Methylnaltrexone Use for Opioid-induced Postoperative Constipation

May 15, 2015 updated by: Deborah J. Vermaire MD, Shriners Hospitals for Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99203
        • Shriners Hospitals for Children- Spokane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study group
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.
Drug: Methylnaltrexone
Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.
Other Names:
  • Relistor
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.
Other Names:
  • Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol
ACTIVE_COMPARATOR: Institutional bowel protocol
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.
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.
Other Names:
  • Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction of post-operative opioid induced constipation
Time Frame: first post-operative week
first post-operative week

Secondary Outcome Measures

Outcome Measure
Time Frame
time to ambulation in post-operative pediatric spinal fusion patients
Time Frame: first post-operative week
first post-operative week

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shriners Hospitals for Children

Investigators

  • Principal Investigator: Deborah J. Vermaire, M.D., Shriners Hospitals for Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (ESTIMATE)

January 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNTX-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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