- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02558010
Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions.
Spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. While the standard management of post-surgical pain involves a multimodal approach, opioids provide the predominant benefit. However, opioid use is associated with many adverse effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease total opioid consumption and adverse effects as well as improve satisfaction with pain management after scoliosis repair.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53201
- Children's Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 10-18 years
- Idiopathic scoliosis
- Fusion levels planned for 10 or greater
- English speaking
- American Society of Anesthesiology (ASA) class 1 - 3
Exclusion Criteria:
- Current narcotic use / History of substance use disorder
- Morphine, hydromorphone or methadone allergies
- Pregnancy
- Seizure disorders
- Bleeding disorders
- Neuromuscular scoliosis
- History of renal or hepatic disease
- Long QT syndrome
- Obstructive sleep apnea
- Body mass index > 40
- Inability to tolerate standard analgesic medications (gabapentin, ketorolac, acetaminophen)
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Methadone Group
Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg.
|
Perioperative IV methadone to be given
Other Names:
Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Other Names:
|
Active Comparator: Control Group
Patient will receive normal saline placebo initially, then morphine prior to emergence.
|
Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Other Names:
control arm
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Opioid Consumption (mg/kg)
Time Frame: 72 hours
|
Total amount of opioids consumed during the first 72 hours after surgery.
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Itching as assessed by number of doses of benadryl required post-operatively
Time Frame: 72 Hours
|
Number of doses benadryl per patient over 3 post-op days
|
72 Hours
|
Patient satisfaction as assessed by the question "How satisfied were you with your pain management?"
Time Frame: 72 hours
|
Responses can range from 0 (very dissatisfied) to 10 (very satisfied)
|
72 hours
|
Nausea as assessed by number of doses of ondansetron required post-operatively
Time Frame: 72 hours
|
Number of doses ondansetron per patient over 3 post-op days
|
72 hours
|
Constipation as assessed by number of days to first bowel movement
Time Frame: 72 hours
|
Number of days to first bowel movement will be recorded for each patient
|
72 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Steven Weisman, MD, Children's Hospital and Health System Foundation, Wisconsin
- Principal Investigator: Roger A Fons, MD, Children's Hospital and Health System Foundation, Wisconsin
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Spinal Diseases
- Bone Diseases
- Spinal Curvatures
- Scoliosis
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Morphine
- Methadone
Other Study ID Numbers
- CHW-Methadone-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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