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

NCT06085573 | Completed

• 2 other identifiers: C0801044NCT06085573
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Keywords

Precedex;; Dexmedetomidine Hydrochloride;; Sedation;; non-intubated;; pediatric;; non-invasive procedures and tests

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Dexmedetomidine Hydrochloride DRUG

\<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.

Also known as: Precedex

Dexmedetomidine Hydrochloride

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Toykyo, 151-8589, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: October 18, 2023
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)