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Methadone in Pediatric Anesthesiology II

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Group 1- 0.4mg/kg IV methadone HCl (Drug); Group 2 - 0.5mg/kg IV methadon HCI (Drug); Group 3 - control no methadone (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Anshuman Sharma, MD, Principal Investigator, Affiliation: Washington University School of Medicine


Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0. 4 and 0. 5 mg/kg).

Clinical Details

Official title: Methadone in Pediatric Anesthesia II

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Morphine consumption

Pain scores

Secondary outcome: Methadone clearance

Detailed description: Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care are not altered for study purposes. All patients are induced by propofol and muscle relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1: 2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0. 4 mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized 1: 2 to either control (standard intraop opioid) or methadone HCl (0. 5 mg/kg ideal body weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. In the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. Patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.


Minimum age: 11 Years. Maximum age: 18 Years. Gender(s): Both.


Inclusion Criteria.

- Age 11-18 years

- Undergoing general anesthesia and idiopathic posterior spinal surgery with

anticipated postop inpatient stay of > 3 days

- Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria.

- History of or known liver or kidney disease.

- Females who are pregnant or nursing.

- Children with developmental delay

- Children undergoing surgery for scoliosis of musculoskeletal origin

Locations and Contacts

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Jane Blood, RN, Phone: 314-757-5531, Email: bloodj@anest.wustl.edu
Anshuman Sharma, MD, Principal Investigator
Additional Information

Starting date: June 2013
Last updated: August 13, 2015

Page last updated: August 23, 2015

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