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Methadone in Pediatric Anesthesia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00921843
First received: June 10, 2009
Last updated: January 13, 2016
Last verified: January 2016

June 10, 2009
January 13, 2016
May 2009
May 2017   (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
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Methadone in Pediatric Anesthesia
Methadone in Pediatric Anesthesia
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.
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Interventional
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
31
May 2017
May 2017   (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   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00921843
08-1195
No
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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
January 2016

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