Prevention of opioid-associated constipation in ventilated intensive care patients
PRevention of Opioid-associated constipation in Ventilated INtensive CarE patients (PROVINCE) Study: A randomised controlled trial of enterally-administered naloxone for the prevention of opioid-associated constipation in ventilated intensive care patients.
Dr Eamon Raith
300 participants
Mar 2, 2020
Interventional
Conditions
Summary
This study will provide information as to whether administration of naloxone to the gut prevents constipation (and its associated complications) in ICU patients; this is important, as it will potentially improve patient comfort, reduce the amount of interventions needed during a patient’s stay in ICU, and may reduce the amount of time that they require ICU care. In this study, one group of ventilated patients will receive a combined preparation of naloxone, while a second group will receive a placebo fluid only, This will be administered via a tube, placed via the nose, in the patient's stomach. This allows us to compare the effect of naloxone on gut function. We hypothesise that administering naloxone will reduce rates of constipation in ICU patients.
Eligibility
Inclusion Criteria5
- Age greater than or equal to 18 years.
- Receiving opiates.
- Mechanically ventilated.
- Suitable for or receiving enteral nutrition.
- Likely to stay in the ICU for at least 72h
Exclusion Criteria4
- Age <18 years.
- Contraindications to the use of enteral naloxone/oxycodone combination.
- Have a colostomy
- Bowel obstruction
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Interventions
Enteral administration of a preparation of Naloxone Hydrochloride: 5mg 8-hourly to ventilated intensive care patients for 7 days. Administration will be performed by the bedside ICU nurse, who will be blinded to the intervention. Administration of the trial drug or control drug will be documented in an appropriate position on the ICU drug chart. A research coordinator will ensure that an appropriate field on the ICU drug chart is present each day.
Locations(1)
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ACTRN12620000207910