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Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients

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ClinicalTrials.gov Identifier: NCT02558010
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Roger A Fons, MD, Medical College of Wisconsin

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Scoliosis Pain Drug: Methadone Other: Normal Saline Drug: Morphine Phase 3

Detailed Description:
This study is a double blind comparison, evaluating the benefits of intraoperative methadone in extensive posterior spine fusion surgery for idiopathic scoliosis. Methadone 0.2 mg/kg will be given to the treatment group. Postoperative evaluation for narcotic use, pain control, and adverse effects will be compared to a standard treatment approach used at Children's Hospital of Wisconsin.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

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.
Drug: Methadone
perioperative IV methadone to be given
Other Name: generic methadone only

Drug: Morphine
Both groups will receive morphine via Patient-Controlled Analgesia pump.

Active Comparator: Control Group
Patient will receive normal saline placebo initially, then morphine prior to emergence.
Other: Normal Saline
control arm
Other Name: salt water

Drug: Morphine
Both groups will receive morphine via Patient-Controlled Analgesia pump.




Primary Outcome Measures :
  1. Post-operative Pain Score on the verbal numeric pain scale [ Time Frame: 72 hours ]
    Scores range from 0 (no pain) - 10 (worst possible pain)


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 10-17 years
  • Idiopathic scoliosis
  • Fusion levels of 10 or greater
  • English speaking
  • American Society of Anesthesiology (ASA) class 1 and 2

Exclusion Criteria:

  • Current narcotic use / History of substance abuse
  • Morphine, hydromorphone or methadone allergies
  • Pregnancy
  • Seizure Disorders
  • Bleeding disorders
  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558010


Contacts
Contact: Keri Hainsworth, PhD 414266-6306 khainsworth@chw.org
Contact: Ellen Edwards, BS eedwards@mcw.edu

Locations
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53201
Contact: Roger A Fons, MD    414-266-3561    rfons@mcw.edu   
Contact: Keri Hainsworth, PhD    4142666306    khainsworth@chw.org   
Sub-Investigator: Steven Weisman, MD         
Principal Investigator: Roger Fons, MD         
Sponsors and Collaborators
Medical College of Wisconsin
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:
Responsible Party: Roger A Fons, MD, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02558010     History of Changes
Other Study ID Numbers: CHW-Methadone-001
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Roger A Fons, MD, Medical College of Wisconsin:
Methadone
Gabapentin
Postoperative Pain
Posterior Spinal Fusion
Pediatric

Additional relevant MeSH terms:
Methadone
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents