A Study to Learn About the Study Medicine - Precedex in Children From Japan.

Active, not recruiting

• Conditions: Sedation
• Interventions: Drug: Dexmedetomidine Hydrochloride

• Registration Number: NCT06085573
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.

This study is seeking for children who are 1 month to less than 18 years old.

The patients are planned to be looked over:

* From the time of patient check before receiving Precedex

* To 1 hour after the completion or stop of using Precedex.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-17
• Study Start: 2023-10-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-06-20
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Pediatric patients (1 month to < 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"

Exclusion Criteria

• No exclusion criteria is set out in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Pediatric patients (1 month to \< 18 years old) administered Precedex (Dexmedetomidine Hydrochloride) for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse drug reactions (ADRs)	From the time of patient assessment before the start of administration of Precedex to 1 hour after the completion or discontinuation of administration

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Toykyo, Japan