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 ISSN 2044-6055.

Preview

PDF 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

Request Changes to record.

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
Subjects:	R Medicine > RC Internal medicine
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
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:	Date Event 7 July 2016 Available 1 July 2016 Published 25 May 2016 Accepted 1 March 2016 Submitted
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 (Creative Commons)
Date of first compliant deposit:	1 August 2018
Date of first compliant Open Access:	1 August 2018
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID PB-PG-0613-31073 [NIHR] National Institute for Health Research http://dx.doi.org/10.13039/501100000272

Request changes or add full text files to a record

Repository staff actions (login required)

View Item

Downloads