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: March 4, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 10, 2009

Last Updated Date

March 4, 2013

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine PKs of IV methadone in children undergoing surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00921843 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Methadone in Pediatric Anesthesia

Official Title ^ICMJE

Methadone in Pediatric Anesthesia

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Anesthesia

Intervention ^ICMJE

Drug: Methadone

Subjects will receive methadone as their intraoperative opioid.

Study Arm (s)

Experimental: Methadone

Methadone administration 0.1mg/kg, 0.2mg/kg or 0.3 mg/kg

Intervention: Drug: Methadone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2014

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00921843

Other Study ID Numbers ^ICMJE

08-1195

Has Data Monitoring Committee

Responsible Party

Washington University School of Medicine

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Evan Kharasch, MD, PhD

Washington University School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

March 2013

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

To Top