Methylnaltrexone Use for Opioid-induced Postoperative Constipation

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773096
• Other study ID #: MNTX-2013
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2013
• Last updated: May 15, 2015
• Start date: May 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Methylnaltrexone
Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.
• 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.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children- Spokane	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (1)

Anissian L, Schwartz HW, Vincent K, Vincent HK, Carpenito J, Stambler N, Ramakrishna T. Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. J Hosp Med. 2012 Feb;7(2):6 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to oral intake of pediatric post-operative spinal fusion patient		first post-operative week
Primary	reduction of post-operative opioid induced constipation		first post-operative week
Secondary	time to ambulation in post-operative pediatric spinal fusion patients		first post-operative week