Overview

This trial is active, not recruiting.

Condition anesthesia
Treatment methadone
Sponsor Washington University School of Medicine
Start date May 2009
End date May 2017
Trial size 31 participants
Trial identifier NCT00921843, 08-1195

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Methadone administration 0.1mg/kg, 0.2mg/kg or 0.3 mg/kg
methadone
Subjects will receive methadone as their intraoperative opioid.

Primary Outcomes

Measure
Determine PKs of IV methadone in children undergoing surgery
time frame: 1 year

Eligibility Criteria

Male or female participants from 5 years up to 18 years old.

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

Additional Information

Official title Methadone in Pediatric Anesthesia
Principal investigator Evan Kharasch, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.