Sedation
Conditions
Keywords
Precedex;, Dexmedetomidine Hydrochloride;, Sedation;, intensive care;, pediatric
Brief summary
Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.
Detailed description
To assess the data, including safety profile, of Precedex Intravenous Solution administered for sedation during and after mechanical ventilation in the intensive care setting in pediatric patients under actual medical practice in Japan. Maruishi Pharmaceutical Co., Ltd. and Pfizer Japan Inc. will collect 50 subjects each.
Interventions
DRUGDexmedetomidine Hydrochloride
\[Sedation during and after mechanical ventilation in the intensive care setting\] For pediatric patients ages of 6 years and over, dexmedetomidine is usually administrated by continuous intravenous (IV) infusion of at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.0 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. For pediatric patients with corrected gestational ages (gestational age + postnatal age) of 45 weeks to under 6 years, dexmedetomidine is usually administrated by continuous IV infusion at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.4 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. The dosing rate could be decreased according to the patient's condition as appropriate.
Sponsors
Maruishi Pharmaceutical
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Weeks to 17 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered this drug for sedation during and after mechanical ventilation in the intensive care setting.
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | From the start of administration of Precedex (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Precedex in a participant who received Precedex. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Precedex was assessed by the physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician | At the end of administration of Precedex (up to Month 33, at the longest) | Overall effectiveness of Precedex was evaluated at the end of Precedex administration by the physician. Clinical effectiveness was evaluated as effective, not effective, or indeterminate by the physician. Clinical effectiveness proportion was defined as the proportion of responders divided by the total number of responders and non-responders. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex for sedation during and after mechanical ventilation in the intensive care setting as indicated in the approved local product document were observed from the start of administration (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest). The dosage can be adjusted as per physician's discretion. | 98 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Invalid registration | 11 |
| Overall Study | No IC* on publication of study results | 2 |
Baseline characteristics
| Characteristic | PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | — |
|---|---|---|
| Age, Customized ≥12 to <24 months of age | 14 Participants | — |
| Age, Customized ≥2 to <6 years | 27 Participants | — |
| Age, Customized ≥45 weeks of corrected gestational age to <12 months of age | 35 Participants | — |
| Age, Customized ≥6 to <18 years | 22 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 46 Participants | — |
| Sex: Female, Male Male | 52 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 98 |
| other Total, other adverse events | 8 / 98 |
| serious Total, serious adverse events | 4 / 98 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Precedex in a participant who received Precedex. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Precedex was assessed by the physician.
Time frame: From the start of administration of Precedex (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest).
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Precedex at least once. Participants with invalid registration or without informed consent were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | Number of Participants With Adverse Drug Reactions | ADR | 9 Participants |
| PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | Number of Participants With Adverse Drug Reactions | Serious ADR | 2 Participants |
Secondary
Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician
Overall effectiveness of Precedex was evaluated at the end of Precedex administration by the physician. Clinical effectiveness was evaluated as effective, not effective, or indeterminate by the physician. Clinical effectiveness proportion was defined as the proportion of responders divided by the total number of responders and non-responders.
Time frame: At the end of administration of Precedex (up to Month 33, at the longest)
Population: The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation by the physician at the end of Precedex administration. Participants who received Precedex for an out-of-scope indication, or those who received inadequate duration or dose of Precedex were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician | Effective | 100.0 Percentage of participants |
| PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician | Not effective | 0.0 Percentage of participants |
| PRECEDEX INTRAVENOUS SOLUTION (Dexmedetomidine Hydrochloride) | Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician | Indeterminate | 0.0 Percentage of participants |