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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

Page last updated: August 23, 2015

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