A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery

NCT02206685 | Completed Phase 4 Results DMC

• 1 other identifier: H32894
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which is a measurement used for evaluation of curves in scoliosis on an anterior-posterior radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40 degrees in the lumbar region) or when the curvature causes significant pain, or respiratory and cardiovascular restriction. Patient undergoing this surgical correction experience severe pain in the postoperative period and the management includes the use of opioid-based patient-controlled analgesia (PCA).

Conditions

Thoracolumbar Scoliosis

Outcome Measures

Primary Outcomes (1)

• Opioid Usage

  Subjects were given access to Patient-Controlled Intravenous Opioid Administration (PCA) to manage their post-operative pain. The doses of morphine were calculated at at PACU, 24 hours, 48 hours and 72 hours respectively.

  Admission to PACU to 72 hours post-operative

Secondary Outcomes (1)

• Pain Scores

  Admission to PACU to 72 hours post-operative

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.

Drug: Methadone

Control Group

PLACEBO COMPARATOR

The control group will receive a 20 ml normal saline placebo infusion over 10 minutes

Drug: Normal Saline

Interventions

Methadone DRUG

The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes

Also known as: Treatment group

Treatment group

Normal Saline DRUG

the control group will receive a 20 ml normal saline placebo infusion over 10 minutes

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient age 10 - 17 years
• Patients undergoing multilevel thoraco-lumbar spine surgery with instrumentation and fusion

You may not qualify if:

• Preoperative methadone therapy
• Inability to use the PCA
• Allergy to methadone or morphine
• Morbid obesity with a body mass index \>36.0 kg/m2
• Patients with chronic renal failure defined by serum creatinine \>2.0 mg/dL
• Liver failure defined as a history of cirrhosis or fulminant hepatic failure
• Preoperative congenital heart disease or arrhythmias
• Patient refusal to participate in study
• Pregnancy (It is standard of care for all post menarche female patients to undergo a urine pregnancy test prior to surgery).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (5)

• Nicholson AB. Methadone for cancer pain. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003971. doi: 10.1002/14651858.CD003971.pub3.

  PMID: 17943808 BACKGROUND

• Gourlay GK, Wilson PR, Glynn CJ. Pharmacodynamics and pharmacokinetics of methadone during the perioperative period. Anesthesiology. 1982 Dec;57(6):458-67. doi: 10.1097/00000542-198212000-00005. No abstract available.

  PMID: 6128949 BACKGROUND

• Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.

  PMID: 20418538 BACKGROUND

• Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.

  PMID: 22037641 BACKGROUND

• Berde CB, Beyer JE, Bournaki MC, Levin CR, Sethna NF. Comparison of morphine and methadone for prevention of postoperative pain in 3- to 7-year-old children. J Pediatr. 1991 Jul;119(1 Pt 1):136-41. doi: 10.1016/s0022-3476(05)81054-6.

  PMID: 2066846 BACKGROUND

MeSH Terms

Interventions

Methadone; Saline Solution; Control Groups

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Kim P. Nguyen, MD, Principal Investigator
• Organization: Baylor College of Medicine

kpnguyen@texaschildrens.org

832-824-5907

Study Officials

• Kim Nguyen, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Anesthesiologist

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 1, 2014
• Study Start: May 1, 2014
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)