None listed
Conditions
Brief summary
Patients who are receiving invasive mechanical ventilation treatment are often prescribed a combination of medications to help keep them calm (sedated), and also to remove pain and discomfort. Two commonly used drugs to relieve discomfort are morphine and fentanyl. These are part of the narcotic group of drugs. Currently, either of these agents is prescribed to many thousands of patients in intensive care units in Australia and New Zealand every year. This study will aim to establish which of these two medications that are commonly used for pain relief and sedation in patients receiving treatment with a breathing machine is better with regards to being able to remove the breathing machine earlier, in addition to decreasing the amount of other medications that may be required for sedation and relief of pain or discomfort.
Interventions
This study will use a design know as a ‘cluster crossover design’. There will be two study treatment periods. Each period is 6 months in duration. There is no washout period between treatments. Following randomised blinded allocation using sealed opaque envelopes, during the first treatment period, one of the ICUs will be instructed to use only morphine or fentanyl for pain relief and sedation in patients who are receiving mechanical ventilation, while the other ICU will be instructed to use
This study will use a design know as a ‘cluster crossover design’. There will be two study treatment periods. Each period is 6 months in duration. There is no washout period between treatments. Following randomised blinded allocation using sealed opaque envelopes, during the first treatment period, one of the ICUs will be instructed to use only morphine or fentanyl for pain relief and sedation in patients who are receiving mechanical ventilation, while the other ICU will be instructed to use morphine or fentanyl. During the second treatment period, each ICU will swap to using the opposite treatment. This means that, in situations where morphine and fentanyl are regarded as being equivalent by the treating clinician, the treatment administered will be determined based on the treatment assigned to the ICU. However, if there is a specific indication NOT to use one or other of the drugs (e.g. an allergy to the drug), then the treatment will be allocated irrespective of the treatment assigned to the ICU, and will be up to the treating clinician. An audit of pharmacy medicine supply logs and a site log of patients with identified contra-indications will be performed.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged equal to or greater than 18 years of age Receiving mechanical ventilation
Exclusion criteria
Admission to the intensive care unit following cardiac surgery. Allergic to morphine Allergic to fentanyl
Outcome results
None listed