NCT01773096

Methylnaltrexone Use for Opioid-induced Postoperative Constipation

The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shriners Hospitals for Children · Academic / Other
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Constipation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-01-23
• Last updated: 2015-05-19

Locations

1 site across 1 country: United States