Precedex Special Investigation (in Pediatric Patients)

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04040439

Collaborator

Maruishi Pharmaceutical (Industry)

110

Enrollment

Location

36.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sedation	Drug: Dexmedetomidine Hydrochloride

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

110 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 30, 2019

Anticipated Primary Completion Date :

Aug 9, 2022

Anticipated Study Completion Date :

Aug 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Dexmedetomidine Hydrochloride 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 [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. Other Names: Precedex

Arm

Intervention/Treatment

Dexmedetomidine Hydrochloride

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

[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.

Other Names:

Precedex

Outcome Measures

Primary Outcome Measures

Number of participants with adverse drug reactions (ADRs) [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)]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Weeks to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.