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

June 10, 2009
March 31, 2014
May 2009
May 2013   (final data collection date for primary outcome measure)
Determine PKs of IV methadone in children undergoing surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00921843 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Methadone in Pediatric Anesthesia
Methadone in Pediatric Anesthesia

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia
Drug: Methadone
Subjects will receive methadone as their intraoperative opioid.
Experimental: Methadone
Methadone administration 0.1mg/kg, 0.2mg/kg or 0.3 mg/kg
Intervention: Drug: Methadone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00921843
08-1195
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Evan Kharasch, MD, PhD Washington University School of Medicine
Washington University School of Medicine
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP