Methylnaltrexone for the Treatment of Opioid Induced Constipation
Research type
Research Study
Full title
Use of Methylnaltrexone for the Treatment of Opioid Induced Constipation & Gastro-Intestinal Stasis in Intensive Care Patients
IRAS ID
153753
Contact name
Parind Patel
Contact email
Eudract number
2014-004687-37
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The drug methylnaltrexone is approved for use in the palliative/end of life care setting for treating constipation caused by opioid drugs. We believe that the use of methylnaltrexone for patients taking opioids will be of even greater benefit in the critical care population.
Opioid drugs form a fundamental part of the sedation and pain relief required for critically ill patients to tolerate mechanical breathing assistance to sustain life. Unfortunately, along with the desired effects of opioids come considerable side effects including pruritus (itching), suppression of the immune system and most clinically relevant gastrointestinal dysfunction. This leads to the upper gastrointestinal passage being unable to properly digest food, constipation leading to stomach bloating, a large immobile stool volume in the bowel (faecal impaction) and infection.
There have been several case reports supporting use of methylnaltrexone in the intensive care setting, and we ourselves have used the drug successfully at Hammersmith Hospital. Our published retrospective study demonstrated a significant prevalence of opioid induced constipation in critical care patients, despite standard treatment given to prevent constipation. Those patients that were treated with methylnaltrexone opened bowels within 24 hours, a result that was not achieved with standard therapy. There were also some benefits in feeding/digestion of food and mortality although these were not statistically significant.
The logical next step is to perform a multi-centre randomised controlled trial comparing methylnaltrexone to placebo following 48 hours of opioid induced constipation, essentially replicating the trials from palliative care in the critical care setting.
The primary outcome of the study will be relief of constipation, with secondary outcomes including tolerance of feeding, infection and mortality. The potential advantages in improving gastrointestinal function as well as reversing the opioid induced immune suppression are likely to be even more ground breaking, as ultimately patient outcome and mortality will be improved.REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/2004
Date of REC Opinion
17 Dec 2014
REC opinion
Further Information Favourable Opinion