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

NCT06085573 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 111

Last updated 2025-08-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2025-06-20
Completion
2025-06-20

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085573 on ClinicalTrials.gov