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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: May 8, 2017
Last verified: May 2017
June 10, 2009
May 8, 2017
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 ]
Same as current
Complete list of historical versions of study NCT00921843 on ClinicalTrials.gov Archive Site
Not Provided
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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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (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 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
Sexes Eligible for Study: All
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
Not Provided
Not Provided
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
May 2017

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