None listed
Conditions
Brief summary
Although experimental and observational studies suggest that a raised body temperature after brain injury may be associated with adverse outcomes for patients, there is no evidence that intervening to reduce temperature improves patient outcomes. Current clinical practice involves the variable use of strategies that modify temperature despite the clinical uncertainty. The PARITY study is part of a programme of research developed at St George Hospital and the George Institute for International Health aiming to provide rigorous, high quality research to assess the effect of interventions that target normothermia after traumatic brain injury on patient-centred outcomes.
Interventions
Dose: Intravenous paracetamol, 1 gram (100mls), administered over 30 minutes.
Schedule: Given every 4 hours for 3 days.
Sponsors
South Eastern Sydney and Illawarra Area Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Written informed consent has been obtained from the patient’s next of kin Age > 18 and < 65 Non penetrating head injury requiring mechanical ventilation, and, with an abnormal CT head (defined by the presence of haemorrhage, contusion, swelling, compression of basal cisterns or herniation) Within 72 hours of injury Presence (or imminent placement) of arterial cannula Alanine transferase level < 100
Exclusion criteria
Suspected paracetamol overdose Clinician decision to institute any intervention that modifies body temperature Body temperature at time of recruitment less that 36 degrees celsius or greater than 38.9 degrees celcius Treatment with paracetamol, non-steroidal anti-inflammatory drugs or steroids in 3 days prior to admission History of chronic liver disease or chronic alcohol abuse Suspected malnutrition or weight < 60 kg Renal failure with serum creatinine > 200 Haemodynamic instability defined as systolic blood pressure < 90 mmhg or requirement for noradrenaline or adrenaline exceeding 20mcg/minute Minor head injury: either normal CT head or not expected to be in intensive care for 72 hours Suspected pregnancy GCS<3 with fixed dilated pupils Moribund patient expected to die within 24 hours Allergy to paracetamol
Outcome results
None listed