Methadone in Pediatric Anesthesia

NCT ID: NCT00921843

Last Updated: 2019-05-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methadone 0.1mg/kg

Methadone 0.1mg/kg

Group Type EXPERIMENTAL

Methadone 0.1mg/kg

Intervention Type DRUG

Subjects will receive methadone as their intraoperative opioid.

Methadone 0.2mg/kg

Methadone 0.2mg/kg

Group Type EXPERIMENTAL

Methadone 0.2mg/kg

Intervention Type DRUG

Subjects will receive methadone as their intraoperative opioid.

Methadone 0.3mg/kg

Methadone 0.3mg/kg

Group Type EXPERIMENTAL

Methadone 0.3mg/kg

Intervention Type DRUG

Subjects will receive methadone as their intraoperative opioid.

Control

No methadone

Group Type PLACEBO_COMPARATOR

Methadone 0.2mg/kg

Intervention Type DRUG

Subjects will receive methadone as their intraoperative opioid.

Control

Intervention Type DRUG

Subjects will not receive methadone as their intraoperative opioid.

Interventions

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Methadone 0.1mg/kg

Subjects will receive methadone as their intraoperative opioid.

Intervention Type DRUG

Methadone 0.2mg/kg

Subjects will receive methadone as their intraoperative opioid.

Intervention Type DRUG

Methadone 0.3mg/kg

Subjects will receive methadone as their intraoperative opioid.

Intervention Type DRUG

Control

Subjects will not receive methadone as their intraoperative opioid.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Evan Kharasch

Vice-Chair for Innovation, Director of Research Entrepreneurship

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evan Kharasch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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08-1195

Identifier Type: -

Identifier Source: org_study_id

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