Methylnaltrexone Use for Opioid-induced Postoperative Constipation

Overview

The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation.

Full Title of Study: “The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2015

Detailed Description

Methylnaltrexone will be given to pediatric patients post-operative from spinal fusion surgery on post-operative day number 3 and then again on postoperative day number 4, if no laxation achieved. Various outcome measures, safety and efficacy of the drug will be observed and recorded.

Interventions

  • Drug: Methylnaltrexone
    • Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.
  • Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax
    • Standard institutional bowel protocol will begin on post-operative day 1. Miralax,Docusate sodium or senna will be given on a weight-based dosing. If no bowel movement in 72 hours, bisacodyl or magnesium hydroxide will be added.

Arms, Groups and Cohorts

  • Experimental: Study group
    • Weight-based dose (0.15 mg/kg for patients less than 38 kg, 8 mg for patients weighing 38-62 kg, or 12 mg for patients weighing greater than 62 kg) of methylnaltrexone will be administered on post-operative day 3 and again, if indicated, on post-operative day 4. This group will also receive the standard bowel protocol beginning on postoperative day one as per protocol.
  • Active Comparator: Institutional bowel protocol
    • Patient will receive institutional standard bowel protocol. Beginning on post-operative day one either miralx,docusate sodium or senna, on a weight-based dose. If no bowel movement in 72 hours, either oral bisacodyl or magnesium hydroxide, on a weight-based dosing, will be added.

Clinical Trial Outcome Measures

Primary Measures

  • reduction of post-operative opioid induced constipation
    • Time Frame: first post-operative week

Secondary Measures

  • time to ambulation in post-operative pediatric spinal fusion patients
    • Time Frame: first post-operative week

Participating in This Clinical Trial

Inclusion Criteria

  • spinal fusion surgery – current opioid use – 12 years of age and older – no or inadequate bowel movement by post-operative day 3 Exclusion Criteria:

  • known or expected mechanical bowel obstruction – known or suspected lesions of the GI tract – unexpected transfer to ICU – unexpected return to the operating room – patient or parent refusal of methylnaltrexone – incomplete data concerning time to laxation

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shriners Hospitals for Children
  • Provider of Information About this Clinical Study
    • Principal Investigator: Deborah J. Vermaire MD, Anesthesiologist – Shriners Hospitals for Children
  • Overall Official(s)
    • Deborah J. Vermaire, M.D., Principal Investigator, Shriners Hospitals for Children

Citations Reporting on Results

Anissian L, Schwartz HW, Vincent K, Vincent HK, Carpenito J, Stambler N, Ramakrishna T. Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. J Hosp Med. 2012 Feb;7(2):67-72. doi: 10.1002/jhm.943. Epub 2011 Oct 13.

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