NCT06085573

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 111 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-10-18
• Primary completion: 2025-06-20
• Completion: 2025-06-20
• First posted: 2023-10-17
• Last updated: 2025-08-21

Locations

1 site across 1 country: Japan