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Methylnaltrexone Use for Opioid-induced Postoperative Constipation

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ClinicalTrials.gov Identifier: NCT01773096
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
Deborah J. Vermaire MD, Shriners Hospitals for Children

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.

Condition or disease Intervention/treatment Phase
Constipation Drug: Methylnaltrexone Drug: Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax Phase 4

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Methylnaltrexone to Reduce Post-operative Opioid-induced Constipation in the Pediatric Spinal Fusion Patient
Study Start Date : May 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


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 Name: 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 Name: 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 Name: Senokot,Colace, Dulcolax, Milk of Magnesia, polyethylene glycol



Primary Outcome Measures :
  1. reduction of post-operative opioid induced constipation [ Time Frame: first post-operative week ]

Secondary Outcome Measures :
  1. time to ambulation in post-operative pediatric spinal fusion patients [ Time Frame: first post-operative week ]

Other Outcome Measures:
  1. time to oral intake of pediatric post-operative spinal fusion patient [ Time Frame: first post-operative week ]


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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773096


Locations
United States, Washington
Shriners Hospitals for Children- Spokane
Spokane, Washington, United States, 99203
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Deborah J. Vermaire, M.D. Shriners Hospitals for Children

Publications of Results:
Responsible Party: Deborah J. Vermaire MD, Anesthesiologist, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01773096     History of Changes
Other Study ID Numbers: MNTX-2013
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Deborah J. Vermaire MD, Shriners Hospitals for Children:
opioid-induced

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Bisacodyl
Polyethylene glycol 3350
Bismuth subsalicylate
Magnesium Hydroxide
Methylnaltrexone
Naltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cathartics
Gastrointestinal Agents
Laxatives
Narcotic Antagonists
Antidiarrheals
Antacids
Molecular Mechanisms of Pharmacological Action