Methadone in Pediatric Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00921843
First received: June 10, 2009
Last updated: March 31, 2014
Last verified: March 2014
  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: 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.

  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

Locations
United States, Missouri
Washington University School of Medicine
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
ClinicalTrials.gov 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:
Anesthetics
Methadone
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on April 20, 2014