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Protocol for a randomised control trial of methylnaltrexone for the treatment of opioid-induced constipation and gastrointestinal stasis in intensive care patients (MOTION)
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Patel, Parind B., Brett, Stephen J., O'Callaghan, David, Anjum, Aisha, Cross, Mary, Warwick, Jane and Gordon, Anthony C. (2016) Protocol for a randomised control trial of methylnaltrexone for the treatment of opioid-induced constipation and gastrointestinal stasis in intensive care patients (MOTION). BMJ Open, 6 (7). e011750. doi:10.1136/bmjopen-2016-011750
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WRAP-protocol-randomised-control-trial-methylnaltrexone-Warwick-2016.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1034Kb) | Preview |
Official URL: http://dx.doi.org/10.1136/bmjopen-2016-011750
Abstract
Introduction
Gastrointestinal dysmotility and constipation are common problems in intensive care patients. The majority of critical care patients are sedated with opioids to facilitate tolerance of endotracheal tubes and mechanical ventilation, which inhibit gastrointestinal motility and lead to adverse outcomes. Methylnaltrexone is a peripheral opioid antagonist that does not cross the blood–brain barrier and can reverse the peripheral side effects of opioids without affecting the desired central properties. This trial will investigate whether methylnaltrexone can reverse opioid-induced constipation and gastrointestinal dysmotility.
Methods
This is a single-centre, multisite, double-blind, randomised, placebo-controlled trial. 84 patients will be recruited from 4 intensive care units (ICUs) within Imperial College Healthcare NHS Trust. Patients will receive intravenous methylnaltrexone or placebo on a daily basis if they are receiving opioid infusion to facilitate mechanical ventilation and have not opened their bowels for 48 hours. All patients will receive standard laxatives as per the clinical ICU bowel protocol prior to randomisation. The primary outcome of the trial will be time to significant rescue-free laxation following randomisation. Secondary outcomes will include tolerance of enteral feed, gastric residual volumes, incidence of pneumonia, blood stream and Clostridium difficile infection, and any reversal of central opioid effects.
Ethics and dissemination
The trial protocol, the patient/legal representative information sheets and consent forms have been reviewed and approved by the Harrow Research Ethics Committee (REC Reference 14/LO/2004). An independent Trial Steering Committee and Data Monitoring Committee are in place, with patient representation. On completion, the trial results will be published in peer-reviewed journals and presented at national and international scientific meetings.
Trial registration number
2014-004687-37
| Item Type: | Journal Article | ||||||||||
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| Subjects: | R Medicine > RC Internal medicine | ||||||||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Opioids -- Side effects, Critical care medicine, Constipation | ||||||||||
| Journal or Publication Title: | BMJ Open | ||||||||||
| Publisher: | BMJ | ||||||||||
| ISSN: | 2044-6055 | ||||||||||
| Official Date: | 1 July 2016 | ||||||||||
| Dates: |
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| Date of first compliant deposit: | 1 August 2018 | ||||||||||
| Volume: | 6 | ||||||||||
| Number: | 7 | ||||||||||
| Article Number: | e011750 | ||||||||||
| DOI: | 10.1136/bmjopen-2016-011750 | ||||||||||
| Status: | Peer Reviewed | ||||||||||
| Publication Status: | Published | ||||||||||
| Access rights to Published version: | Open Access | ||||||||||
| RIOXX Funder/Project Grant: |
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