drugset / Trial / NCT02977286
Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study evaluates the addition of naloxegol (Movantik) to a laxative protocol in critically ill adults requiring scheduled opioid (e.g. fentanyl) therapy. Half of the participants will receive naloxegol and a laxative protocol and half the participants will receive a placebo and a laxative protocol.
Timeline
- Start
- 2017-01-01
- Primary completion
- 2019-10-09
- Completion
- 2019-10-09
Publications
- Background Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.
- Background de Azevedo RP, Freitas FG, Ferreira EM, Pontes de Azevedo LC, Machado FR. Daily laxative therapy reduces organ dysfunction in mechanically ventilated patients: a phase II randomized controlled trial. Crit Care. 2015 Sep 16;19(1):329. doi: 10.1186/s13054-015-1047-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naloxegol | Small molecule | 12.5 mg | Oral |
| Subject | Naloxegol | Small molecule | 25 mg | Oral |
| Background | Bisacodyl | Small molecule | 10 mg | Rectal |
| Background | Docusate Sodium | Unknown | 100 mg | Oral |
| Background | Magnesium Citrate | Unknown | — | Oral |
| Background | Methylnaltrexone | Other / unclassified | 8 mg | Subcutaneous |
| Background | Methylnaltrexone | Other / unclassified | 16 mg | Subcutaneous |
| Background | Polyethylene Glycols | Unknown | 17 g | — |
| Background | Polyethylene Glycols | Unknown | 34 g | — |
| Background | Senna | Traditional medicine (herbal / TCM) | 127 mg | Oral |