Precedex Special Investigation (in Pediatric Patients)

Study Overview
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Brief Summary
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Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.

Detailed Description
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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.

Official Title
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Precedex(Registered) Intravenous Solution Special Investigation (in Pediatric Patients)

Conditions
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Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria is set out in this study.

Ages Eligible for Study
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Minimum Age: 45 Weeks
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexmedetomidine Hydrochloride<br>Pediatric patients (45 weeks corrected gestational age to <18 years old) administered Precedex (Dexmedetomidine Hydrochloride) for sedation during and after mechanical ventilation in the intensive care setting | Drug: Dexmedetomidine Hydrochloride<br>* [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.<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse drug reactions (ADRs) | Regarding Time Frame, if a participant leaves the ICU before 24 hours after the end of administration of Precedex, adverse events (AEs) observed up to 24 hours after the end of administration should be entered in the case report form (CRF) as much as possible, and the AEs should be monitored until the outcomes become known as far as possible. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who are evaluated as effective (responders) by the investigator | Effectiveness evaluation (effective, not effective, or indeterminate) of Precedex will be performed by investigators at the end of administration of this drug. | At the end of administration of Precedex (up to Month 33, at the longest) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Precedex;, Dexmedetomidine Hydrochloride;, Sedation;, intensive care;, pediatric