Methadone in Pediatric Anesthesia

This study is currently recruiting participants.

Verified by Washington University School of Medicine, September 2009

First Received: June 10, 2009 Last Updated: September 11, 2009 History of Changes

Sponsor:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00921843

Purpose

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

Condition	Intervention
Anesthesia	Drug: Methadone

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Methadone in Pediatric Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Determine PKs of IV methadone in children undergoing surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will receive methadone as their intraoperative opioid.

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921843

Contacts

Contact: Jane Blood, RN	314-747-5531	bloodj@wustl.edu
Contact: Evan D Kharasch, MD, PhD	314-362-8796	kharasch@wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Evan Kharasch, MD, PhD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University School of Medicine ( Evan Kharasch, MD, PhD )
Study ID Numbers:	08-1195
Study First Received:	June 10, 2009
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00921843 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Pediatric patients undergoing surgery

Additional relevant MeSH terms:

Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Methadone
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010