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Methadone in Pediatric Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921843
First Posted: June 16, 2009
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  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: Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date: May 2009
Study Completion Date: May 2017
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921843


Locations
United States, Missouri
Washington University School of Medicine
Saint 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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00921843     History of Changes
Other Study ID Numbers: 08-1195
First Submitted: June 10, 2009
First Posted: June 16, 2009
Last Update Posted: May 9, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents