Methylnaltrexone Use for Opioid-induced Postoperative Constipation

Phase 4

Completed

• Conditions: Constipation
• Interventions: Drug: Methylnaltrexone; Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax

• Registration Number: NCT01773096
• Lead Sponsor: Shriners Hospitals for Children

Brief 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.

Study Timeline

• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-23
• Study Start: 2013-05
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-15
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax	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.
Institutional bowel protocol	Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax	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.
Study group	Methylnaltrexone	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.

Primary Outcome Measures

Name	Time	Method
reduction of post-operative opioid induced constipation	first post-operative week

Secondary Outcome Measures

Name	Time	Method
time to ambulation in post-operative pediatric spinal fusion patients	first post-operative week

Trial Locations

Locations (1)

Shriners Hospitals for Children- Spokane; 🇺🇸 Spokane, Washington, United States