Not Yet RecruitingPhase 4ACTRN12620000207910

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.


Sponsor

Dr Eamon Raith

Enrollment

300 participants

Start Date

Mar 2, 2020

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

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 w

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)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12620000207910


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