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

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.

Completed

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Key information

Conditions

Sedation

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Toykyo, 151-8589, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Precedex

Primary outcomes

Number of participants with adverse drug reactions (ADRs)

Time frame: From the time of patient assessment before the start of administration of Precedex to 1 hour after the completion or discontinuation of administration

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Oct 17, 2023
Registry last updated: Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed