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.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000207910

Acronym

PROVINCE

Enrollment

300

Registered

2020-02-20

Start date

2020-03-02

Completion date

2021-02-07

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- 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 criteria

- Age <18 years. - Contraindications to the use of enteral naloxone/oxycodone combination. - Have a colostomy - Bowel obstruction

Outcome results