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NCT00921843 Clinical Trial

Methadone in Pediatric Anesthesia

Anesthesia Clinical Trial

Official title:
Methadone in Pediatric Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00921843
Other study ID # 08-1195
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2009
Est. completion date May 2011

Study information
Verified date April 2019
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Methadone 0.1mg/kg
Subjects will receive methadone as their intraoperative opioid.
• Methadone 0.2mg/kg
Subjects will receive methadone as their intraoperative opioid.
• Methadone 0.3mg/kg
Subjects will receive methadone as their intraoperative opioid.
• Control
Subjects will not receive methadone as their intraoperative opioid.

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary R-methadone Plasma AUC 0-96hr/Dose 96 hr
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