MRI Sedation
Conditions
Keywords
procedural sedation, dexmedetomidine, propofol, MRI
Brief summary
This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to \<17 years of age undergoing MRI scans in the US and Japan.
Interventions
DRUGdexmedetomidine
dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan
DRUGpropofol
propofol IV administration will be given if needed to maintain sedation
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female subject ≥1 month and \<17 years of age. 2. American Society of Anesthesiologists (ASA) Physical Status I, II or III. 3. Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or other proceduralist in attendance. 4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete Key
Exclusion criteria
1. Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects. 2. Weight on Day 1 before randomization is less than the 10th percentile of weight for age and sex in the US and Japan or is greater than the 95th percentile of weight for age and sex in the US or greater than the 97th percentile of weight for age and sex in Japan based on sponsor-provided growth charts. 3. Planned medical procedure during the MRI scan or post-MRI recovery period. 4. Requires endotracheal intubation or laryngeal mask airway (LMA). 5. Known allergy to eggs, egg products, soybeans or soybean products. 6. SpO2 \<93 % on room air -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | Up to maximum of 3 hours during MRI scan on Day 1 | Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | Up to maximum of 3 hours during MRI scan on Day 1 | Percentage of participants who did not require PRO to complete MRI scan in each age cohort and combined age cohorts are reported in this outcome measure. |
| Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | Up to maximum of 3 hours during MRI scan on Day 1 | In this outcome measure percentage of time for which participant had maintained PSSS score of 2 was reported. PSSS score ranges from 0 to 5, where 0= sedation with abnormal physiologic parameters requiring acute intervention, 1= sedation with normal vital signs, but requiring airway intervention, 2= no movement during procedure, no frown, no verbalization of complaint indicating no pain and anxiety, 3= no movement during procedure but expression of pain and anxiety on face, verbalization of complaint, requiring help positioning, 4= movement during procedure requiring gentle immobilization for positioning, verbalization of some discomfort or stress, but no crying or shouting that expresses stress or objection, 5= movement impeding proceduralist and requiring forceful immobilization, crying or shouting during procedure, but vocalization not required. Higher score indicated less sedation. |
| Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | Up to maximum of 3 hours during MRI scan on Day 1 | Participants who did not have PRO administered were censored. |
| Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI | Up to maximum of 3 hours during MRI scan on Day 1 | Percentage of participants who did not require PRO to complete MRI scan in each age cohort are reported in this outcome measure. |
| Number of Participants Who Received PRO - By Age Cohort and Combined Age | Up to maximum of 3 hours during MRI scan on Day 1 | — |
| Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | Up to maximum of 3 hours during MRI scan on Day 1 | — |
| Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | Up to maximum of 3 hours during MRI scan on Day 1 | — |
| Emergence Time - By Age Cohort and Combined Age | Post MRI scan on Day 1 up to 24 hours | Emergence time: time from the end of the MRI scan to when the participant met a Modified Aldrete score \>=9. Participants who were withdrawn or discharged without reaching a Modified Aldrete score \>=9, were censored, time computed from end of MRI scan to time of the last clinical assessment (vital signs). Zero minute was used as the censored time if no vital signs were taken during the post-MRI recovery period. Modified Aldrete score: validated observational medical scoring system that allowed verbal prompts for the measurement of recovery after anesthesia (post anesthesia) which included items: activity, respiration, circulation, consciousness, and oxygenation. Each item was scored from 0 to 2, higher scores signified better recovery. The scores of each item were summed to obtain a total score of 0 to 10, where higher scores indicated well recovered participant post anesthesia. |
Countries
Japan, United States
Participant flow
Recruitment details
Total 141 participants were screened. Out of 141 participants, only 128 participants who met eligibility criteria signed the informed consent document, were enrolled and randomized. Out of 128 randomized participants, 6 participants were not treated.
Pre-assignment details
Pediatric participants were administered with dexmedetomidine (DEX), and with propofol (PRO) as needed, for procedural sedation for magnetic resonance imaging (MRI) scans.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose: Age >=1 Month to <2 Years Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug. | 20 |
| Middle Dose: Age >=1 Month to <2 Years Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug. | 21 |
| High Dose: Age >=1 Month to <2 Years Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug. | 18 |
| Low Dose: Age >=2 Years to <17 Years Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug. | 22 |
| Middle Dose: Age >=2 Years to <17 Years Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug. | 21 |
| High Dose: Age >=2 Years to <17 Years Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug. | 20 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Treatment (Day 1) | Adverse Event | 1 | 0 | 0 | 0 | 1 | 1 |
| Treatment (Day 1) | Not treated | 1 | 1 | 2 | 1 | 0 | 1 |
| Treatment (Day 1) | Other | 0 | 0 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Low Dose: Age >=1 Month to <2 Years | Middle Dose: Age >=1 Month to <2 Years | High Dose: Age >=1 Month to <2 Years | Low Dose: Age >=2 Years to <17 Years | Middle Dose: Age >=2 Years to <17 Years | High Dose: Age >=2 Years to <17 Years | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 0.99 Years STANDARD_DEVIATION 0.612 | 0.90 Years STANDARD_DEVIATION 0.488 | 0.96 Years STANDARD_DEVIATION 0.384 | 6.68 Years STANDARD_DEVIATION 2.922 | 7.40 Years STANDARD_DEVIATION 3.23 | 6.63 Years STANDARD_DEVIATION 3.277 | 4.02 Years STANDARD_DEVIATION 3.743 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 7 Participants | 0 Participants | 3 Participants | 3 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 18 Participants | 11 Participants | 22 Participants | 17 Participants | 17 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 8 Participants | 4 Participants | 11 Participants | 8 Participants | 7 Participants | 41 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) White | 10 Participants | 8 Participants | 11 Participants | 10 Participants | 9 Participants | 9 Participants | 57 Participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 8 Participants | 11 Participants | 10 Participants | 9 Participants | 59 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 10 Participants | 11 Participants | 11 Participants | 11 Participants | 63 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 | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 | 0 / 18 | 0 / 59 | 0 / 22 | 0 / 21 | 0 / 20 | 0 / 63 |
| other Total, other adverse events | 19 / 20 | 20 / 21 | 17 / 18 | 56 / 59 | 19 / 22 | 19 / 21 | 19 / 20 | 57 / 63 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 | 0 / 18 | 0 / 59 | 0 / 22 | 0 / 21 | 1 / 20 | 1 / 63 |
Outcome results
Primary
Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Population: FAS included all randomized participants who received any amount of DEX.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Dose: Combined Age | Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 63.2 Percentage of participants |
| Low Dose: Combined Age | Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 14.3 Percentage of participants |
p-value: <0.00195% CI: [0.03, 0.29]Cochran-Mantel-Haenszel
Secondary
Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Population: FAS included all randomized participants who received any amount of DEX. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose: Combined Age | Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 59.43 mcg per kg per minute | Standard Deviation 18.625 |
| Low Dose: Combined Age | Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 71.38 mcg per kg per minute | Standard Deviation 32.895 |
| High Dose: Age >=2 Years to <17 Years | Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 47.41 mcg per kg per minute | Standard Deviation 14.454 |
| Low Dose: Age >=2 Years to <17 Years | Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 81.28 mcg per kg per minute | Standard Deviation 38.406 |
| Middle Dose: Age >=2 Years to <17 Years | Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 74.70 mcg per kg per minute | Standard Deviation 24.487 |
| Low Dose: Age >=2 Years to <17 Years | Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 76.36 mcg per kg per minute | Standard Deviation 47.656 |
| High Dose: Combined Age | Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 70.96 mcg per kg per minute | Standard Deviation 32.243 |
| Middle Dose: Combined Age | Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 72.28 mcg per kg per minute | Standard Deviation 30.418 |
| Low Dose: Combined Age | Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 56.31 mcg per kg per minute | Standard Deviation 30.007 |
p-value: 0.048ANOVA
p-value: 0.106ANOVA
p-value: 0.196ANOVA
p-value: 0.94ANOVA
p-value: 0.824ANOVA
p-value: 0.678ANOVA
p-value: 0.129ANOVA
p-value: 0.16ANOVA
p-value: 0.872ANOVA
Secondary
Emergence Time - By Age Cohort and Combined Age
Emergence time: time from the end of the MRI scan to when the participant met a Modified Aldrete score \>=9. Participants who were withdrawn or discharged without reaching a Modified Aldrete score \>=9, were censored, time computed from end of MRI scan to time of the last clinical assessment (vital signs). Zero minute was used as the censored time if no vital signs were taken during the post-MRI recovery period. Modified Aldrete score: validated observational medical scoring system that allowed verbal prompts for the measurement of recovery after anesthesia (post anesthesia) which included items: activity, respiration, circulation, consciousness, and oxygenation. Each item was scored from 0 to 2, higher scores signified better recovery. The scores of each item were summed to obtain a total score of 0 to 10, where higher scores indicated well recovered participant post anesthesia.
Time frame: Post MRI scan on Day 1 up to 24 hours
Population: FAS included all randomized participants who received any amount of DEX.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Dose: Combined Age | Emergence Time - By Age Cohort and Combined Age | 30.0 Minutes |
| Low Dose: Combined Age | Emergence Time - By Age Cohort and Combined Age | 41.0 Minutes |
| High Dose: Age >=2 Years to <17 Years | Emergence Time - By Age Cohort and Combined Age | 38.0 Minutes |
| Low Dose: Age >=2 Years to <17 Years | Emergence Time - By Age Cohort and Combined Age | 35.0 Minutes |
| Middle Dose: Age >=2 Years to <17 Years | Emergence Time - By Age Cohort and Combined Age | 46.0 Minutes |
| Low Dose: Age >=2 Years to <17 Years | Emergence Time - By Age Cohort and Combined Age | 50.0 Minutes |
| High Dose: Combined Age | Emergence Time - By Age Cohort and Combined Age | 35.0 Minutes |
| Middle Dose: Combined Age | Emergence Time - By Age Cohort and Combined Age | 42.5 Minutes |
| Low Dose: Combined Age | Emergence Time - By Age Cohort and Combined Age | 45.5 Minutes |
p-value: 0.884Log Rank
p-value: 0.662Log Rank
p-value: 0.236Log Rank
p-value: 0.733Log Rank
p-value: 0.128Log Rank
p-value: 0.165Log Rank
p-value: 0.752Log Rank
p-value: 0.139Log Rank
p-value: 0.051Log Rank
Secondary
Number of Participants Who Received PRO - By Age Cohort and Combined Age
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Population: FAS included all randomized participants who received any amount of DEX.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Dose: Combined Age | Number of Participants Who Received PRO - By Age Cohort and Combined Age | 17 Participants |
| Low Dose: Combined Age | Number of Participants Who Received PRO - By Age Cohort and Combined Age | 19 Participants |
| High Dose: Age >=2 Years to <17 Years | Number of Participants Who Received PRO - By Age Cohort and Combined Age | 9 Participants |
| Low Dose: Age >=2 Years to <17 Years | Number of Participants Who Received PRO - By Age Cohort and Combined Age | 19 Participants |
| Middle Dose: Age >=2 Years to <17 Years | Number of Participants Who Received PRO - By Age Cohort and Combined Age | 8 Participants |
| Low Dose: Age >=2 Years to <17 Years | Number of Participants Who Received PRO - By Age Cohort and Combined Age | 5 Participants |
| High Dose: Combined Age | Number of Participants Who Received PRO - By Age Cohort and Combined Age | 36 Participants |
| Middle Dose: Combined Age | Number of Participants Who Received PRO - By Age Cohort and Combined Age | 27 Participants |
| Low Dose: Combined Age | Number of Participants Who Received PRO - By Age Cohort and Combined Age | 14 Participants |
Secondary
Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI
Percentage of participants who did not require PRO to complete MRI scan in each age cohort are reported in this outcome measure.
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Population: FAS included all randomized participants who received any amount of DEX.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Dose: Combined Age | Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI | 50.0 Percentage of participants |
| Low Dose: Combined Age | Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI | 15.0 Percentage of participants |
| High Dose: Age >=2 Years to <17 Years | Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI | 75.0 Percentage of participants |
| Low Dose: Age >=2 Years to <17 Years | Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI | 13.6 Percentage of participants |
p-value: 0.02295% CI: [0.04, 0.82]Mantel Haenszel
p-value: <0.00195% CI: [0.01, 0.26]Mantel Haenszel
Secondary
Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
Percentage of participants who did not require PRO to complete MRI scan in each age cohort and combined age cohorts are reported in this outcome measure.
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Population: FAS included all randomized participants who received any amount of DEX.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Dose: Combined Age | Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 50.0 Percentage of participants |
| Low Dose: Combined Age | Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 9.5 Percentage of participants |
| High Dose: Age >=2 Years to <17 Years | Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 15.0 Percentage of participants |
| Low Dose: Age >=2 Years to <17 Years | Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 75.0 Percentage of participants |
| Middle Dose: Age >=2 Years to <17 Years | Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 61.9 Percentage of participants |
| Low Dose: Age >=2 Years to <17 Years | Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 13.6 Percentage of participants |
| High Dose: Combined Age | Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 63.2 Percentage of participants |
| Middle Dose: Combined Age | Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 35.7 Percentage of participants |
| Low Dose: Combined Age | Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI | 14.3 Percentage of participants |
p-value: 0.00695% CI: [0.02, 0.59]Mantel Haenszel
p-value: 0.59795% CI: [0.25, 11.27]Mantel Haenszel
p-value: 0.37495% CI: [0.14, 2.07]Mantel Haenszel
p-value: 0.00195% CI: [0.02, 0.44]Mantel Haenszel
p-value: 0.01595% CI: [0.13, 0.81]Mantel Haenszel
p-value: 0.02495% CI: [0.1, 0.87]Mantel Haenszel
Secondary
Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age
In this outcome measure percentage of time for which participant had maintained PSSS score of 2 was reported. PSSS score ranges from 0 to 5, where 0= sedation with abnormal physiologic parameters requiring acute intervention, 1= sedation with normal vital signs, but requiring airway intervention, 2= no movement during procedure, no frown, no verbalization of complaint indicating no pain and anxiety, 3= no movement during procedure but expression of pain and anxiety on face, verbalization of complaint, requiring help positioning, 4= movement during procedure requiring gentle immobilization for positioning, verbalization of some discomfort or stress, but no crying or shouting that expresses stress or objection, 5= movement impeding proceduralist and requiring forceful immobilization, crying or shouting during procedure, but vocalization not required. Higher score indicated less sedation.
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Population: FAS included all randomized participants who received any amount of DEX. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose: Combined Age | Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | 77.5 Percentage of time | Standard Deviation 15.94 |
| Low Dose: Combined Age | Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | 82.5 Percentage of time | Standard Deviation 12.04 |
| High Dose: Age >=2 Years to <17 Years | Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | 87.8 Percentage of time | Standard Deviation 23.93 |
| Low Dose: Age >=2 Years to <17 Years | Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | 76.8 Percentage of time | Standard Deviation 18.36 |
| Middle Dose: Age >=2 Years to <17 Years | Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | 92.2 Percentage of time | Standard Deviation 9.72 |
| Low Dose: Age >=2 Years to <17 Years | Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | 94.1 Percentage of time | Standard Deviation 12.22 |
| High Dose: Combined Age | Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | 77.2 Percentage of time | Standard Deviation 17.04 |
| Middle Dose: Combined Age | Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | 87.2 Percentage of time | Standard Deviation 11.88 |
| Low Dose: Combined Age | Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age | 91.1 Percentage of time | Standard Deviation 18.71 |
p-value: 0.021Wilcoxon (Mann-Whitney)
p-value: 0.007Wilcoxon (Mann-Whitney)
p-value: 0.225Wilcoxon (Mann-Whitney)
p-value: 0.213Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: 0.006Wilcoxon (Mann-Whitney)
p-value: 0.011Wilcoxon (Mann-Whitney)
p-value: <0.001Wilcoxon (Mann-Whitney)
p-value: 0.004Wilcoxon (Mann-Whitney)
Secondary
Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age
Participants who did not have PRO administered were censored.
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Population: FAS included all randomized participants who received any amount of DEX.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Dose: Combined Age | Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | 16.0 Minutes |
| Low Dose: Combined Age | Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | 17.0 Minutes |
| High Dose: Age >=2 Years to <17 Years | Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | 62.0 Minutes |
| Low Dose: Age >=2 Years to <17 Years | Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | 16.5 Minutes |
| Middle Dose: Age >=2 Years to <17 Years | Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | NA Minutes |
| Low Dose: Age >=2 Years to <17 Years | Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | NA Minutes |
| High Dose: Combined Age | Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | 16.0 Minutes |
| Middle Dose: Combined Age | Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | 31.5 Minutes |
| Low Dose: Combined Age | Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age | NA Minutes |
p-value: 0.016Log Rank
p-value: 0.005Log Rank
p-value: 0.368Log Rank
p-value: 0.358Log Rank
p-value: 0Log Rank
p-value: 0.001Log Rank
p-value: 0.02Log Rank
p-value: 0Log Rank
p-value: 0.005Log Rank
Secondary
Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age
Time frame: Up to maximum of 3 hours during MRI scan on Day 1
Population: FAS included all randomized participants who received any amount of DEX. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose: Combined Age | Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 4012.1 mcg per kg | Standard Deviation 2334.66 |
| Low Dose: Combined Age | Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 4730.3 mcg per kg | Standard Deviation 3398.21 |
| High Dose: Age >=2 Years to <17 Years | Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 2822.8 mcg per kg | Standard Deviation 1593.84 |
| Low Dose: Age >=2 Years to <17 Years | Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 5559.2 mcg per kg | Standard Deviation 4038.95 |
| Middle Dose: Age >=2 Years to <17 Years | Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 5001.9 mcg per kg | Standard Deviation 4093.7 |
| Low Dose: Age >=2 Years to <17 Years | Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 4513.0 mcg per kg | Standard Deviation 4620.56 |
| High Dose: Combined Age | Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 4828.6 mcg per kg | Standard Deviation 3390.42 |
| Middle Dose: Combined Age | Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 4810.7 mcg per kg | Standard Deviation 3538.71 |
| Low Dose: Combined Age | Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age | 3426.4 mcg per kg | Standard Deviation 2973 |
p-value: 0.124ANOVA
p-value: 0.186ANOVA
p-value: 0.47ANOVA
p-value: 0.845ANOVA
p-value: 0.621ANOVA
p-value: 0.747ANOVA
p-value: 0.218ANOVA
p-value: 0.181ANOVA
p-value: 0.984ANOVA