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

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06085573

Collaborator

(none)

110

Enrollment

48.3

Anticipated Duration (Months)

Study Details

Study Description

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.

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

110 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Precedex Intravenous Injections Special Investigation (Sedation of Non-intubated Pediatric Patients for Non-invasive Procedures and Tests)

Anticipated Study Start Date :

Oct 31, 2023

Anticipated Primary Completion Date :

Nov 9, 2027

Anticipated Study Completion Date :

Nov 9, 2027

Arms and Interventions

Arm	Intervention/Treatment
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"	Drug: Dexmedetomidine Hydrochloride <Sedation of non-invasive procedures and tests without intubation in pediatrics> For children aged 2 years or older, the usual dosage of dexmedetomidine is 12 μg/kg/hr given as a continuous intravenous infusion over 10 minutes (initial loading dose) followed by a maintenance dose of 1.5 μg/kg/hr (maintenance dose). For children aged 1 month to < 2 years old, the usual dosage of dexmedetomidine is 9 μg/kg/hr given as a continuous intravenous infusion over 10 minutes (initial loading dose) followed by a maintenance dose of 1.5 μg/kg/hr (maintenance dose). The infusion rate should be reduced according to patient's condition. Other Names: Precedex

Arm

Intervention/Treatment

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"

Drug: Dexmedetomidine Hydrochloride

<Sedation of non-invasive procedures and tests without intubation in pediatrics> For children aged 2 years or older, the usual dosage of dexmedetomidine is 12 μg/kg/hr given as a continuous intravenous infusion over 10 minutes (initial loading dose) followed by a maintenance dose of 1.5 μg/kg/hr (maintenance dose). For children aged 1 month to < 2 years old, the usual dosage of dexmedetomidine is 9 μg/kg/hr given as a continuous intravenous infusion over 10 minutes (initial loading dose) followed by a maintenance dose of 1.5 μg/kg/hr (maintenance dose). The infusion rate should be reduced according to patient's condition.

Other Names:

Precedex

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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"