Methylnaltrexone Use for Opioid-induced Postoperative Constipation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Shriners Hospitals for Children
Sponsor:
Information provided by (Responsible Party):
Deborah J. Vermaire MD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01773096
First received: January 15, 2013
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Constipation
Drug: Methylnaltrexone
Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • reduction of post-operative opioid induced constipation [ Time Frame: first post-operative week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time to ambulation in post-operative pediatric spinal fusion patients [ Time Frame: first post-operative week ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • time to oral intake of pediatric post-operative spinal fusion patient [ Time Frame: first post-operative week ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Methylnaltrexone
Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.
Other Name: Relistor
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.
Other Name: Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol
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.
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.
Other Name: Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol

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.

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773096

Contacts
Contact: Deborah J. Vermaire, M.D. 509-623-0428 dvermaire@shrinenet.org

Locations
United States, Washington
Shriners Hospitals for Children- Spokane Recruiting
Spokane, Washington, United States, 99203
Contact: Vermaire, M.D.    509-623-0428      
Contact: Charlotte Preuschoff    509-623-0427      
Principal Investigator: Deborah J. Vermaire, M.D.         
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Deborah J. Vermaire, M.D. Shriners Hospitals for Children
  More Information

Publications:
Responsible Party: Deborah J. Vermaire MD, Anesthesiologist, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01773096     History of Changes
Other Study ID Numbers: MNTX-2013
Study First Received: January 15, 2013
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
opioid-induced

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Bisacodyl
Bismuth subsalicylate
Magnesium Hydroxide
Methylnaltrexone
Naltrexone
Analgesics, Opioid
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antidiarrheals
Antacids
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 24, 2014