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Completed

NCT Number: NCT01773096

Methylnaltrexone Use for Opioid-induced Postoperative Constipation

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shriners Hospitals for Children- Spokane

Spokane, Washington, 99203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylnaltrexone

Drug

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

Other names: Relistor

Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax

Drug

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

Primary outcomes

  1. reduction of post-operative opioid induced constipation

    Time frame: first post-operative week

Secondary outcomes

  1. time to ambulation in post-operative pediatric spinal fusion patients

    Time frame: first post-operative week

Other outcomes

  1. time to oral intake of pediatric post-operative spinal fusion patient

    Time frame: first post-operative week

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2013
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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