Methylnaltrexone Use for Opioid-induced Postoperative Constipation
Information source: Shriners Hospitals for Children
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Constipation
Intervention: Methylnaltrexone (Drug); Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Shriners Hospitals for Children Official(s) and/or principal investigator(s): Deborah J. Vermaire, M.D., Principal Investigator, Affiliation: Shriners Hospitals for Children
Summary
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.
Clinical Details
Official title: The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: reduction of post-operative opioid induced constipation
Secondary outcome: time to ambulation in post-operative pediatric spinal fusion patients
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
Minimum age: 12 Years.
Maximum age: 21 Years.
Gender(s): Both.
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
Locations and Contacts
Shriners Hospitals for Children- Spokane, Spokane, Washington 99203, United States
Additional Information
Starting date: May 2013
Last updated: May 15, 2015
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