Methadone in Pediatric Anesthesia

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Methadone 0.2mg/kg; Drug: Methadone 0.3mg/kg; Drug: Methadone 0.1mg/kg; Drug: Control

• Registration Number: NCT00921843
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2018-06-18
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-19
• Last Update Submitted: 2019-04-19
• Results First Posted: 2019-05-14
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Age 5-18
• Undergoing General anesthesia and surgery with anticipated postoperative inpatient stay of greater than or equal to 3 days
• Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria

• History of or known liver or kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Methadone 0.2mg/kg	No methadone
Methadone 0.3mg/kg	Methadone 0.3mg/kg	Methadone 0.3mg/kg
Methadone 0.2mg/kg	Methadone 0.2mg/kg	Methadone 0.2mg/kg
Methadone 0.1mg/kg	Methadone 0.1mg/kg	Methadone 0.1mg/kg
Control	Control	No methadone

Primary Outcome Measures

Name	Time	Method
R-methadone Plasma AUC 0-96hr/Dose	96 hr

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States