Methadone in Pediatric Anesthesia

The Washington University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Control; Drug: Methadone 0.1mg/kg; Drug: Methadone 0.2mg/kg; Drug: Methadone 0.3mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT00921843

08-1195

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 4 patient groups, including a placebo group

Methadone 0.1mg/kg

Experimental group

Description:

Methadone 0.1mg/kg

Treatment:

Drug: Methadone 0.1mg/kg

Methadone 0.2mg/kg

Experimental group

Description:

Methadone 0.2mg/kg

Treatment:

Drug: Methadone 0.2mg/kg

Methadone 0.3mg/kg

Experimental group

Description:

Methadone 0.3mg/kg

Treatment:

Drug: Methadone 0.3mg/kg

Control

Placebo Comparator group

Description:

No methadone

Treatment:

Drug: Control

Drug: Methadone 0.2mg/kg