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Methylnaltrexone Use for Opioid-induced Postoperative Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methylnaltrexone
Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax
Sponsored by
Shriners Hospitals for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring opioid-induced

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Shriners Hospitals for Children- Spokane

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Institutional bowel protocol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

reduction of post-operative opioid induced constipation

Secondary Outcome Measures

time to ambulation in post-operative pediatric spinal fusion patients

Full Information

First Posted
January 15, 2013
Last Updated
May 15, 2015
Sponsor
Shriners Hospitals for Children
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1. Study Identification

Unique Protocol Identification Number
NCT01773096
Brief Title
Methylnaltrexone Use for Opioid-induced Postoperative Constipation
Official Title
The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
opioid-induced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Institutional bowel protocol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylnaltrexone
Other Intervention Name(s)
Relistor
Intervention Description
Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.
Intervention Type
Drug
Intervention Name(s)
Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax
Other Intervention Name(s)
Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol
Intervention Description
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.
Primary Outcome Measure Information:
Title
reduction of post-operative opioid induced constipation
Time Frame
first post-operative week
Secondary Outcome Measure Information:
Title
time to ambulation in post-operative pediatric spinal fusion patients
Time Frame
first post-operative week
Other Pre-specified Outcome Measures:
Title
time to oral intake of pediatric post-operative spinal fusion patient
Time Frame
first post-operative week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah J. Vermaire, M.D.
Organizational Affiliation
Shriners Hospitals for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children- Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21998076
Citation
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):67-72. doi: 10.1002/jhm.943. Epub 2011 Oct 13.
Results Reference
result

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Methylnaltrexone Use for Opioid-induced Postoperative Constipation

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