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Methadone in Pediatric Anesthesia

This study has been completed.
Information provided by (Responsible Party):
Washington University School of Medicine Identifier:
First received: June 10, 2009
Last updated: March 31, 2014
Last verified: March 2014

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

Condition Intervention
Drug: Methadone

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Methadone in Pediatric Anesthesia

Resource links provided by NLM:

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 ]

Enrollment: 31
Study Start Date: May 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methadone
Methadone administration 0.1mg/kg, 0.2mg/kg or 0.3 mg/kg
Drug: Methadone
Subjects will receive methadone as their intraoperative opioid.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00921843

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Evan Kharasch, MD, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine Identifier: NCT00921843     History of Changes
Other Study ID Numbers: 08-1195
Study First Received: June 10, 2009
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Pediatric patients undergoing surgery

Additional relevant MeSH terms:
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses processed this record on November 19, 2014