Methadone in Pediatric Anesthesiology II

NCT01990573 | Completed Results

• 1 other identifier: 201302099
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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 (0.3 and 0.4 mg/kg).

Conditions

Pain

Keywords

spinal surgery; Methadone

Outcome Measures

Primary Outcomes (2)

• Total Opioid Consumption (Morphine Equivalent)

  Measure of overall morphine consumption

  6 days

• Pain Scores

  Assessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated .

  6 days

Secondary Outcomes (1)

• Cmax of R and S Methadone

  96 hours

Study Arms (3)

methadone HCl 0.3 mg/kg

EXPERIMENTAL

0.3mg/kg IV methadone HCl

Drug: 0.3mg/kg IV methadone HCl

methadone HCl 0.4 mg/kg

EXPERIMENTAL

0.4mg/kg IV methadon HCl

Drug: 0.4mg/kg IV methadon HCl

control group

ACTIVE COMPARATOR

control no methadone, standard of care opioids.

Other: control no methadone

Interventions

0.3mg/kg IV methadone HCl DRUG

Group I will receive 0.3mg/kg IV methadone HCl

Also known as: methadone HCl, dolophine

methadone HCl 0.3 mg/kg

0.4mg/kg IV methadon HCl DRUG

Group II will receive 0.4mg/kg IV methadone HCl.

Also known as: methadone HCl, dolophine

methadone HCl 0.4 mg/kg

control no methadone OTHER

The control group will not receive methadone.

control group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Amidines; Methadone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organic Chemicals; Ketones

Results Point of Contact

• Title: Dr. Anshuman Sharma
• Organization: Washington University School of Medicine

sharma.a@wustl.edu

314-457-3147

Study Officials

• Anshuman Sharma, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 21, 2013
• Study Start: April 10, 2013
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: January 28, 2020
• Results First Posted: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)