ICU Sedation
Conditions
Brief summary
To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects \[≥ 45 weeks CGA (corrected gestational age) to \<17 years old\] requiring sedation under intensive care unit
Interventions
DRUGDexmedetomidine hydrochloride
* 45 weeks CGA to \< 6 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.4 µg/kg/h according to the pediatric subject's sedative state * 6 years old to \< 17 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.0 µg/kg/h according to the pediatric subject's sedative state
Sponsors
Maruishi Pharmaceutical
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Weeks to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects whose consent is obtained in writing prior to the clinical trial from a guardian after a full explanation. For subjects over 7 years old, it is desirable that an informed assent is also obtained from the pediatric subject him/herself when possible. 2. Subjects aged ≥45 weeks CGA to \<17 years old at time of consent. No restriction on sex of subject. 3. \[Elective surgical cases\] Subjects classified as American Society of Anesthesiologists (ASA) (ASA physical status classification) Class I to III by preoperative diagnosis. 4. \[Elective surgical cases\] Subjects who require at least 6 hours of respiratory management with intubation under intensive care from immediately after surgery and are anticipated to require sedation. 5. \[Medical ICU cases\] Subjects who require at least 24 hours of respiratory management with intubation under intensive care and are anticipated to require sedation. For medical ICU cases, sedatives used prior to treatment with the investigational product should be discontinued before the start of treatment with the investigational product. 6. If a subject is a female of childbearing potential, she should not be pregnant or possibly pregnant, or lactating.
Exclusion criteria
1. Subjects who are judged by investigator or sub-investigator to have a neurological disease that will make sedation assessment difficult, such as: * Subjects with brain damage which is expected to increase intracranial pressure due to trauma or central nervous system disease * Subjects with cerebral palsy, autism, severe mental retardation, etc. * Subjects with paralysis due to continuous administration of a muscle relaxant or due to a spinal injury of class T5 or higher. 2. Subjects with 2nd or 3rd degree heart block during the tests at the screening visit (excluding subjects using a pacemaker). 3. Subjects with any of the following low blood pressure levels during the tests at the screening visit: * Age ≥ 45 weeks CGA to \< 1 year old: Systolic Blood Pressure (SBP) \<70 mmHg * Age ≥ 1 year old to \< 10 years old: SBP \< 70 + (2 x age in years) mmHg * Age ≥ 10 years old to \< 17 years old: SBP \< 90 mmHg 4. Subject of bradycardia (≤10th centile of heart rate for healthy children) during the physical examination at screening period. 5. Subjects with ALT ≥100 U/L during the laboratory tests at the screening visit. 6. Subjects in whom dexmedetomidine or other alfa 2 receptor agonists, alfa 2 receptor antagonists and drug that may be used in this study are contraindicated. 7. Subjects who may need a sedative or analgesic (including narcotics) other than dexmedetomidine, midazolam or fentanyl during treatment with the investigational product. 8. Subjects who have acute febrile illness \[with a temperature (core or tympanic) ≥ 38.0°Centigrade\] at the screening visit. 9. Subjects who received other investigational product within 30 days before baseline or subjects who will participate in other study that uses an investigational product during the study period. 10. Subjects who received dexmedetomidine within 48 hours before baseline. 11. Subjects who, in the opinion of the investigator or sub-investigator, may be at increased risk to the subject due to the conduct of the study or may have a disease or factor which will probably preclude the obtainment of sufficient study data. 12. Subjects for whom, in the opinion of the investigator or sub-investigator, risks involved with administration of dexmedetomidine outweigh its benefits (e.g., \>2 doses of vasopressor due to cardiogenic shock). 13. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Sponsor's employees directly involved in the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) | Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation \[placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs\], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation \[removal of endotracheal tube\], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) | Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue analgesic (Fentanyl) based on the investigator's judgement were reported. |
| Percentage of Maintenance Duration of Target Sedation Level After Extubation | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) | Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive. |
| Total Amount of Rescue Sedative Taken After Extubation | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) | Total amount of rescue sedative (Midazolam) administered by the participants after extubation. |
| Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) | Total amount of rescue sedative (midazolam) administered by the participants after extubation. Dose was adjusted for body weight (mg divided by kg). |
| Total Amount of Rescue Analgesic Taken After Extubation | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) | Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. |
| Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) | Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. Dose was adjusted for body weight (mcg divided by kg). |
| Median Time to Conclusion of Mechanical Ventilation | Baseline (start of study drug dosing) until end of mechanical ventilation (up to 28 days) | Time to conclusion of mechanical ventilation was defined as time duration from start of study drug administration until the end of mechanical ventilation. |
| Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) | Percentage of participants who did not require administration of a rescue analgesic (Fentanyl) in addition to administration of the study drug based on investigator's judgement were reported. |
| Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) | Total amount of rescue sedative (midazolam) administered Within 24 Hours of dosing of study drug. |
| Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) | Total amount of rescue sedative (midazolam) required within 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg). |
| Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) | Total amount of rescue sedative (fentanyl) required Within 24 Hours of dosing of study drug. |
| Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) | Total amount of rescue analgesic (fentanyl) within 24 Hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg). |
| Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) | Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the SBS. SBS was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive. |
| Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug | From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days) | Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive. |
| Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) | Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and SBS (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation \[placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs\], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation \[removal of endotracheal tube\], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported. |
| Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) | Total amount of rescue sedative (midazolam) administered after 24 hours of dosing of study drug. |
| Body Weight Adjusted Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) | Total amount of rescue sedative (midazolam) required after 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg). |
| Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) | Total amount of rescue analgesic (Fentanyl) administered by the participants after 24 hours of dosing of study drug. |
| Body Weight Adjusted Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) | Total amount of rescue analgesic (fentanyl) after 24 hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg). |
| Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) | Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more stability and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more stability. |
| Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days) | Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive. |
| Duration of Maintenance of Target Sedation Level After Extubation | From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days) | Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Laboratory Test Abnormalities | Baseline up to 28 days after end of study drug dosing (Day 56) | Criteria for abnormality: hemoglobin, hematocrit and red blood cell count \<0.8\*lower limit of normal(LLN); platelet \<0.5\*LLN; \>1.75\*upper limit of normal(ULN); white blood cell count \<0.6\*LLN; \>1.5\*ULN; lymphocytes, neutrophils and stab cells \<0.8\*LLN; \>1.2\*ULN; eosinophils, basophils and monocytes \>1.2\*ULN; total bilirubin \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase and gamma guanosine triphosphate and alkaline phosphatase \>3\*ULN; total protein and albumin \<0.8\*LLN; \>1.2\*ULN; glucose \<0.6\*LLN; \>1.5\*ULN; blood urea nitrogen and creatinine \>1.3\*ULN; uric acid \>1.2\*ULN; sodium \<0.95\*LLN; \>1.05\*ULN, potassium, calcium and magnesium \<0.9\*LLN; \>1.1\*ULN; phosphate \<0.8\*LLN; \>1.2\*ULN. |
| Total Input/Output Fluid Volume | Baseline up to 28 days after end of study drug dosing (Day 56) | Total input fluid volume was defined as the quantity of total fluids administered and total output fluid volume was defined as the quantity of total fluids excreted or lost during the specified evaluation period. |
| Incidence of Potential Withdrawal Symptoms | Baseline up to 28 days after end of study drug dosing (Day 56) | The potential withdrawal symptoms were defined as AEs that occurred or worsened after end of administration of dexmedetomidine. It included bradycardia, abdominal discomfort, abdominal pain, dry mouth, nausea, vomiting, injection site pain, pyrexia, body temperature increased, electrocardiogram QT prolonged, neuralgia, agitation, atelectasis, oropharyngeal pain and hypotension. Incidence of potential withdrawal symptoms was reported in terms of number of participants who had any of the mentioned withdrawal symptoms. |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Baseline up to 28 days after end of study drug dosing (Day 56) | Criteria for clinically significant electrocardiogram abnormalities was based on Investigators decision. |
| Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | Baseline up to 28 days after end of study drug dosing (up to 56 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to up to 28 days after end of study drug dosing (up to 56 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious adverse events (AEs) and SAEs. |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to 28 days after end of study drug dosing (Day 56) | Vital signs included: systolic and diastolic blood pressure, heart rate, respiratory rate, percutaneous oxygen saturation, end-tidal carbon dioxide, core body temperature and body weight. Criteria for clinically significant vital signs abnormalities was based on Investigators decision. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. | 14 |
| Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. | 18 |
| Dexmedetomidine: >=2 Years to <6 Years Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. | 19 |
| Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state. | 12 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Investigator's discretion | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Dexmedetomidine: >=45 Weeks CGA to <12 Months | Total | Dexmedetomidine: >=6 Years to <17 Years | Dexmedetomidine: >=2 Years to <6 Years | Dexmedetomidine: >=12 Months to <24 Months |
|---|---|---|---|---|---|
| Age, Continuous | 6.1 months STANDARD_DEVIATION 2.1 | 41.3 months STANDARD_DEVIATION 41.8 | 112.1 months STANDARD_DEVIATION 37.9 | 45.7 months STANDARD_DEVIATION 14.6 | 16.9 months STANDARD_DEVIATION 3.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 63 Participants | 12 Participants | 19 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 27 Participants | 5 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 36 Participants | 7 Participants | 12 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 18 | 0 / 19 | 0 / 12 | 0 / 63 |
| other Total, other adverse events | 11 / 14 | 16 / 18 | 16 / 19 | 12 / 12 | 55 / 63 |
| serious Total, serious adverse events | 0 / 14 | 0 / 18 | 1 / 19 | 0 / 12 | 1 / 63 |
Outcome results
Primary
Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug
Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation \[placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs\], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation \[removal of endotracheal tube\], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.
Time frame: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
Population: FAS included all participants who received at least one dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug | 78.6 percentage of participants |
| Dexmedetomidine: >=12 Months to <24 Months | Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug | 66.7 percentage of participants |
| Dexmedetomidine: >=2 Years to <6 Years | Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug | 78.9 percentage of participants |
| Dexmedetomidine: >=6 Years to <17 Years | Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug | 91.7 percentage of participants |
| Dexmedetomidine: All Participants | Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug | 77.8 percentage of participants |
Secondary
Body Weight Adjusted Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Total amount of rescue analgesic (fentanyl) after 24 hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg).
Time frame: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).
Secondary
Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation
Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. Dose was adjusted for body weight (mcg divided by kg).
Time frame: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dexmedetomidine: >=2 Years to <6 Years | Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation | 3.00 mcg/kg |
| Dexmedetomidine: All Participants | Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation | 3.00 mcg/kg |
Secondary
Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug
Total amount of rescue analgesic (fentanyl) within 24 Hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg).
Time frame: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | 15.00 mcg/kg | Standard Deviation 9.899 |
| Dexmedetomidine: >=2 Years to <6 Years | Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | 5.00 mcg/kg | Standard Deviation 0 |
| Dexmedetomidine: >=6 Years to <17 Years | Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | 3.78 mcg/kg | Standard Deviation 1.311 |
| Dexmedetomidine: All Participants | Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | 7.16 mcg/kg | Standard Deviation 6.789 |
Secondary
Body Weight Adjusted Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Total amount of rescue sedative (midazolam) required after 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg).
Time frame: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period).
Secondary
Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation
Total amount of rescue sedative (midazolam) administered by the participants after extubation. Dose was adjusted for body weight (mg divided by kg).
Time frame: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation | 0.109 mg/kg | Standard Deviation 0.0976 |
| Dexmedetomidine: >=12 Months to <24 Months | Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation | 0.072 mg/kg | Standard Deviation 0.0304 |
| Dexmedetomidine: >=2 Years to <6 Years | Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation | 0.370 mg/kg | — |
| Dexmedetomidine: All Participants | Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation | 0.146 mg/kg | Standard Deviation 0.1364 |
Secondary
Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug
Total amount of rescue sedative (midazolam) required within 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg).
Time frame: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug | 0.135 mg/kg | Standard Deviation 0.116 |
| Dexmedetomidine: >=12 Months to <24 Months | Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug | 0.353 mg/kg | Standard Deviation 0.2219 |
| Dexmedetomidine: >=2 Years to <6 Years | Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug | 0.142 mg/kg | Standard Deviation 0.0668 |
| Dexmedetomidine: >=6 Years to <17 Years | Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug | 0.100 mg/kg | Standard Deviation 0 |
| Dexmedetomidine: All Participants | Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug | 0.228 mg/kg | Standard Deviation 0.1866 |
Secondary
Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more stability and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more stability.
Time frame: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)
Population: Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 0.81 hours | Standard Deviation 0.672 |
| Dexmedetomidine: >=2 Years to <6 Years | Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 0.92 hours | Standard Deviation 0 |
| Dexmedetomidine: All Participants | Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 0.84 hours | Standard Deviation 0.479 |
Secondary
Duration of Maintenance of Target Sedation Level After Extubation
Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time frame: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)
Population: FAS included all participants who received at least one dose of the study drug. Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Duration of Maintenance of Target Sedation Level After Extubation | 11.68 hours | Standard Deviation 11.589 |
| Dexmedetomidine: >=12 Months to <24 Months | Duration of Maintenance of Target Sedation Level After Extubation | 7.73 hours | Standard Deviation 7.543 |
| Dexmedetomidine: >=2 Years to <6 Years | Duration of Maintenance of Target Sedation Level After Extubation | 7.60 hours | Standard Deviation 4.355 |
| Dexmedetomidine: >=6 Years to <17 Years | Duration of Maintenance of Target Sedation Level After Extubation | 6.73 hours | Standard Deviation 5.036 |
| Dexmedetomidine: All Participants | Duration of Maintenance of Target Sedation Level After Extubation | 8.42 hours | Standard Deviation 7.679 |
Secondary
Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug
Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the SBS. SBS was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time frame: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
Population: FAS included all participants who received at least one dose of the study drug. Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 7.95 hours | Standard Deviation 7.191 |
| Dexmedetomidine: >=12 Months to <24 Months | Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 3.89 hours | Standard Deviation 2.859 |
| Dexmedetomidine: >=2 Years to <6 Years | Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 3.52 hours | Standard Deviation 5.495 |
| Dexmedetomidine: >=6 Years to <17 Years | Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 2.96 hours | Standard Deviation 2.017 |
| Dexmedetomidine: All Participants | Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 4.50 hours | Standard Deviation 5.112 |
Secondary
Median Time to Conclusion of Mechanical Ventilation
Time to conclusion of mechanical ventilation was defined as time duration from start of study drug administration until the end of mechanical ventilation.
Time frame: Baseline (start of study drug dosing) until end of mechanical ventilation (up to 28 days)
Population: FAS: all participants who received at least one dose of the investigational product.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Median Time to Conclusion of Mechanical Ventilation | 9.5 hours |
| Dexmedetomidine: >=12 Months to <24 Months | Median Time to Conclusion of Mechanical Ventilation | 6.0 hours |
| Dexmedetomidine: >=2 Years to <6 Years | Median Time to Conclusion of Mechanical Ventilation | 4.1 hours |
| Dexmedetomidine: >=6 Years to <17 Years | Median Time to Conclusion of Mechanical Ventilation | 4.5 hours |
| Dexmedetomidine: All Participants | Median Time to Conclusion of Mechanical Ventilation | 6.0 hours |
Secondary
Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time frame: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)
Population: Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 75.00 percentage of time | Standard Deviation 35.355 |
| Dexmedetomidine: >=2 Years to <6 Years | Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 100.00 percentage of time | Standard Deviation 0 |
| Dexmedetomidine: All Participants | Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 83.33 percentage of time | Standard Deviation 28.868 |
Secondary
Percentage of Maintenance Duration of Target Sedation Level After Extubation
Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time frame: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)
Population: FAS included all participants who received at least one dose of the study drug. Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Percentage of Maintenance Duration of Target Sedation Level After Extubation | 69.99 Percentage of time | Standard Deviation 28.26 |
| Dexmedetomidine: >=12 Months to <24 Months | Percentage of Maintenance Duration of Target Sedation Level After Extubation | 53.93 Percentage of time | Standard Deviation 28.613 |
| Dexmedetomidine: >=2 Years to <6 Years | Percentage of Maintenance Duration of Target Sedation Level After Extubation | 54.45 Percentage of time | Standard Deviation 30.805 |
| Dexmedetomidine: >=6 Years to <17 Years | Percentage of Maintenance Duration of Target Sedation Level After Extubation | 55.82 Percentage of time | Standard Deviation 41.195 |
| Dexmedetomidine: All Participants | Percentage of Maintenance Duration of Target Sedation Level After Extubation | 58.19 Percentage of time | Standard Deviation 31.829 |
Secondary
Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug
Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive.
Time frame: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
Population: FAS included all participants who received at least one dose of the study drug. Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 54.08 percentage of time | Standard Deviation 31.825 |
| Dexmedetomidine: >=12 Months to <24 Months | Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 60.97 percentage of time | Standard Deviation 28.104 |
| Dexmedetomidine: >=2 Years to <6 Years | Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 50.54 percentage of time | Standard Deviation 27.898 |
| Dexmedetomidine: >=6 Years to <17 Years | Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 62.25 percentage of time | Standard Deviation 34.836 |
| Dexmedetomidine: All Participants | Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug | 56.54 percentage of time | Standard Deviation 29.911 |
Secondary
Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug
Percentage of participants who did not require administration of a rescue analgesic (Fentanyl) in addition to administration of the study drug based on investigator's judgement were reported.
Time frame: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
Population: FAS included all participants who received at least one dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug | 85.7 percentage of participants |
| Dexmedetomidine: >=12 Months to <24 Months | Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug | 100.0 percentage of participants |
| Dexmedetomidine: >=2 Years to <6 Years | Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug | 94.7 percentage of participants |
| Dexmedetomidine: >=6 Years to <17 Years | Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug | 66.7 percentage of participants |
| Dexmedetomidine: All Participants | Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug | 88.9 percentage of participants |
Secondary
Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue analgesic (Fentanyl) based on the investigator's judgement were reported.
Time frame: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)
Population: Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 100.0 percentage of participants |
| Dexmedetomidine: >=2 Years to <6 Years | Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 100.0 percentage of participants |
| Dexmedetomidine: All Participants | Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 100.0 percentage of participants |
Secondary
Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and SBS (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation \[placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs\], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation \[removal of endotracheal tube\], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.
Time frame: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)
Population: Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 100.0 percentage of participants |
| Dexmedetomidine: >=2 Years to <6 Years | Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 100.0 percentage of participants |
| Dexmedetomidine: All Participants | Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation | 100.0 percentage of participants |
Secondary
Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Total amount of rescue analgesic (Fentanyl) administered by the participants after 24 hours of dosing of study drug.
Time frame: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).
Secondary
Total Amount of Rescue Analgesic Taken After Extubation
Total amount of rescue analgesic (fentanyl) administered by the participants after extubation.
Time frame: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Dexmedetomidine: >=2 Years to <6 Years | Total Amount of Rescue Analgesic Taken After Extubation | 42.90 mcg |
| Dexmedetomidine: All Participants | Total Amount of Rescue Analgesic Taken After Extubation | 42.90 mcg |
Secondary
Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug
Total amount of rescue sedative (fentanyl) required Within 24 Hours of dosing of study drug.
Time frame: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | 91.70 micrograms | Standard Deviation 78.772 |
| Dexmedetomidine: >=2 Years to <6 Years | Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | 97.50 micrograms | Standard Deviation 0 |
| Dexmedetomidine: >=6 Years to <17 Years | Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | 81.74 micrograms | Standard Deviation 15.754 |
| Dexmedetomidine: All Participants | Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug | 86.84 micrograms | Standard Deviation 34.676 |
Secondary
Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug
Total amount of rescue sedative (midazolam) administered Within 24 Hours of dosing of study drug.
Time frame: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug | 0.882 milligrams (mg) | Standard Deviation 0.8282 |
| Dexmedetomidine: >=12 Months to <24 Months | Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug | 3.188 milligrams (mg) | Standard Deviation 1.6935 |
| Dexmedetomidine: >=2 Years to <6 Years | Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug | 2.469 milligrams (mg) | Standard Deviation 1.3975 |
| Dexmedetomidine: >=6 Years to <17 Years | Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug | 1.960 milligrams (mg) | — |
| Dexmedetomidine: All Participants | Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug | 2.401 milligrams (mg) | Standard Deviation 1.5793 |
Secondary
Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation
Total amount of rescue sedative (midazolam) administered after 24 hours of dosing of study drug.
Time frame: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).
Secondary
Total Amount of Rescue Sedative Taken After Extubation
Total amount of rescue sedative (Midazolam) administered by the participants after extubation.
Time frame: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)
Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Total Amount of Rescue Sedative Taken After Extubation | 0.537 mg | Standard Deviation 0.3741 |
| Dexmedetomidine: >=12 Months to <24 Months | Total Amount of Rescue Sedative Taken After Extubation | 0.719 mg | Standard Deviation 0.3379 |
| Dexmedetomidine: >=2 Years to <6 Years | Total Amount of Rescue Sedative Taken After Extubation | 5.994 mg | — |
| Dexmedetomidine: All Participants | Total Amount of Rescue Sedative Taken After Extubation | 1.701 mg | Standard Deviation 2.4148 |
Other Pre-specified
Incidence of Potential Withdrawal Symptoms
The potential withdrawal symptoms were defined as AEs that occurred or worsened after end of administration of dexmedetomidine. It included bradycardia, abdominal discomfort, abdominal pain, dry mouth, nausea, vomiting, injection site pain, pyrexia, body temperature increased, electrocardiogram QT prolonged, neuralgia, agitation, atelectasis, oropharyngeal pain and hypotension. Incidence of potential withdrawal symptoms was reported in terms of number of participants who had any of the mentioned withdrawal symptoms.
Time frame: Baseline up to 28 days after end of study drug dosing (Day 56)
Population: Safety analysis set included all participants who received at least one dose of the investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Electrocardiogram QT prolonged | 0 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Body temperature increased | 1 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Pyrexia | 1 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Bradycardia | 0 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Oropharyngeal pain | 0 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Abdominal pain | 0 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Atelectasis | 1 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Dry mouth | 0 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Hypotension | 0 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Agitation | 1 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Nausea | 0 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Abdominal discomfort | 0 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Neuralgia | 0 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Vomiting | 1 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Incidence of Potential Withdrawal Symptoms | Injection site pain | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Vomiting | 1 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Injection site pain | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Bradycardia | 4 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Body temperature increased | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Dry mouth | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Neuralgia | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Pyrexia | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Agitation | 1 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Oropharyngeal pain | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Abdominal discomfort | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Electrocardiogram QT prolonged | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Abdominal pain | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Hypotension | 1 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Atelectasis | 1 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Incidence of Potential Withdrawal Symptoms | Nausea | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Pyrexia | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Bradycardia | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Abdominal discomfort | 1 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Abdominal pain | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Dry mouth | 1 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Nausea | 2 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Vomiting | 1 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Injection site pain | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Body temperature increased | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Electrocardiogram QT prolonged | 1 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Neuralgia | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Agitation | 1 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Atelectasis | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Oropharyngeal pain | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Incidence of Potential Withdrawal Symptoms | Hypotension | 1 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Neuralgia | 1 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Abdominal pain | 1 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Electrocardiogram QT prolonged | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Atelectasis | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Nausea | 3 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Dry mouth | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Abdominal discomfort | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Hypotension | 1 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Pyrexia | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Bradycardia | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Agitation | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Injection site pain | 1 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Oropharyngeal pain | 1 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Body temperature increased | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Incidence of Potential Withdrawal Symptoms | Vomiting | 4 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Body temperature increased | 1 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Oropharyngeal pain | 1 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Electrocardiogram QT prolonged | 1 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Nausea | 5 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Bradycardia | 4 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Neuralgia | 1 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Dry mouth | 1 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Agitation | 3 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Abdominal pain | 1 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Hypotension | 3 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Atelectasis | 2 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Abdominal discomfort | 1 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Pyrexia | 1 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Injection site pain | 1 Participants |
| Dexmedetomidine: All Participants | Incidence of Potential Withdrawal Symptoms | Vomiting | 7 Participants |
Other Pre-specified
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs included: systolic and diastolic blood pressure, heart rate, respiratory rate, percutaneous oxygen saturation, end-tidal carbon dioxide, core body temperature and body weight. Criteria for clinically significant vital signs abnormalities was based on Investigators decision.
Time frame: Baseline up to 28 days after end of study drug dosing (Day 56)
Population: Safety analysis set included all participants who received at least one dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Dexmedetomidine: All Participants | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
Other Pre-specified
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Criteria for clinically significant electrocardiogram abnormalities was based on Investigators decision.
Time frame: Baseline up to 28 days after end of study drug dosing (Day 56)
Population: Safety analysis set included all participants who received at least one dose of the investigational product. Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 Participants |
| Dexmedetomidine: All Participants | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 Participants |
Other Pre-specified
Number of Participants With Laboratory Test Abnormalities
Criteria for abnormality: hemoglobin, hematocrit and red blood cell count \<0.8\*lower limit of normal(LLN); platelet \<0.5\*LLN; \>1.75\*upper limit of normal(ULN); white blood cell count \<0.6\*LLN; \>1.5\*ULN; lymphocytes, neutrophils and stab cells \<0.8\*LLN; \>1.2\*ULN; eosinophils, basophils and monocytes \>1.2\*ULN; total bilirubin \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase and gamma guanosine triphosphate and alkaline phosphatase \>3\*ULN; total protein and albumin \<0.8\*LLN; \>1.2\*ULN; glucose \<0.6\*LLN; \>1.5\*ULN; blood urea nitrogen and creatinine \>1.3\*ULN; uric acid \>1.2\*ULN; sodium \<0.95\*LLN; \>1.05\*ULN, potassium, calcium and magnesium \<0.9\*LLN; \>1.1\*ULN; phosphate \<0.8\*LLN; \>1.2\*ULN.
Time frame: Baseline up to 28 days after end of study drug dosing (Day 56)
Population: Safety analysis set included all participants who received at least one dose of the investigational product. Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Number of Participants With Laboratory Test Abnormalities | 13 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Number of Participants With Laboratory Test Abnormalities | 18 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Number of Participants With Laboratory Test Abnormalities | 15 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Number of Participants With Laboratory Test Abnormalities | 11 Participants |
| Dexmedetomidine: All Participants | Number of Participants With Laboratory Test Abnormalities | 57 Participants |
Other Pre-specified
Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to up to 28 days after end of study drug dosing (up to 56 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious adverse events (AEs) and SAEs.
Time frame: Baseline up to 28 days after end of study drug dosing (up to 56 days)
Population: Safety analysis set included all participants who received at least one dose of the investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | AEs | 11 Participants |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | SAEs | 0 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | AEs | 16 Participants |
| Dexmedetomidine: >=12 Months to <24 Months | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | SAEs | 0 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | AEs | 16 Participants |
| Dexmedetomidine: >=2 Years to <6 Years | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | SAEs | 1 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | SAEs | 0 Participants |
| Dexmedetomidine: >=6 Years to <17 Years | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | AEs | 12 Participants |
| Dexmedetomidine: All Participants | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | AEs | 55 Participants |
| Dexmedetomidine: All Participants | Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | SAEs | 1 Participants |
Other Pre-specified
Total Input/Output Fluid Volume
Total input fluid volume was defined as the quantity of total fluids administered and total output fluid volume was defined as the quantity of total fluids excreted or lost during the specified evaluation period.
Time frame: Baseline up to 28 days after end of study drug dosing (Day 56)
Population: Safety analysis set included all participants who received at least one dose of the investigational product. Here N signifies number of participants who were evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Total Input/Output Fluid Volume | Input Volume | 779.39 milliliters (mL) | Standard Deviation 342.617 |
| Dexmedetomidine: >=45 Weeks CGA to <12 Months | Total Input/Output Fluid Volume | Output Volume | 975.06 milliliters (mL) | Standard Deviation 436.904 |
| Dexmedetomidine: >=12 Months to <24 Months | Total Input/Output Fluid Volume | Input Volume | 799.18 milliliters (mL) | Standard Deviation 356.254 |
| Dexmedetomidine: >=12 Months to <24 Months | Total Input/Output Fluid Volume | Output Volume | 801.53 milliliters (mL) | Standard Deviation 353.379 |
| Dexmedetomidine: >=2 Years to <6 Years | Total Input/Output Fluid Volume | Input Volume | 1023.60 milliliters (mL) | Standard Deviation 337.825 |
| Dexmedetomidine: >=2 Years to <6 Years | Total Input/Output Fluid Volume | Output Volume | 1041.80 milliliters (mL) | Standard Deviation 356.375 |
| Dexmedetomidine: >=6 Years to <17 Years | Total Input/Output Fluid Volume | Output Volume | 1313.58 milliliters (mL) | Standard Deviation 625.474 |
| Dexmedetomidine: >=6 Years to <17 Years | Total Input/Output Fluid Volume | Input Volume | 1415.96 milliliters (mL) | Standard Deviation 822.212 |
| Dexmedetomidine: All Participants | Total Input/Output Fluid Volume | Input Volume | 979.24 milliliters (mL) | Standard Deviation 520.514 |
| Dexmedetomidine: All Participants | Total Input/Output Fluid Volume | Output Volume | 1009.58 milliliters (mL) | Standard Deviation 461.471 |