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NCT06085573 Clinical Trial

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

Sedation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06085573
Other study ID # C0801044
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2023
Est. completion date November 9, 2027

Study information
Verified date November 2023
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 110
Est. completion date November 9, 2027
Est. primary completion date November 9, 2027
Accepts healthy volunteers No
Gender All
Age group 1 Month to 17 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Japan Pfizer Toykyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT02171910 - Doxapram as an Additive to Propofol Sedation in Sedation for ERCP Phase 4
Completed NCT02211118 - Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD Phase 4
Completed NCT01694745 - EUROpean Pain Audit In Neonates N/A
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