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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01773096

Enrollment

Registered

2013-01-23

Start date

2013-05-31

Completion date

2015-05-31

Last updated

2015-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

opioid-induced

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.

Interventions

DRUGMethylnaltrexone

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

DRUGSenna, 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 21 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
reduction of post-operative opioid induced constipation	first post-operative week

Secondary

Measure	Time frame
time to ambulation in post-operative pediatric spinal fusion patients	first post-operative week

Other

Measure	Time frame
time to oral intake of pediatric post-operative spinal fusion patient	first post-operative week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026