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Methadone in Pediatric Anesthesia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Washington University School of Medicine Identifier:
First received: June 10, 2009
Last updated: January 13, 2016
Last verified: January 2016
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.

Condition Intervention
Drug: Methadone

Study Type: Interventional
Study Design: 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 ]

Enrollment: 31
Study Start Date: May 2009
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (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   (Child, Adult)
Sexes Eligible for Study:   All
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

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: January 13, 2016

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

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents processed this record on March 28, 2017