NCT01231139.

Trial name or title	The Paracetamol AfteR Traumatic Brain InjurY Study (PARITY)
Methods	Randomised Controlled Trial
Participants	Age > 18 and < 65
Interventions	Intervention: Paracetamol dissolved in 0.9% Sodium Chloride. Intravenous paracetamol, 1 gram (100mls), administered over 30 minutes (every 4 hours for 3 days). Control: 0.9% Sodium Chloride. 100mls saline given intravenous over 30 minutes (every 4 hours for 3 days).
Outcomes	Primary outcome: Core body temperature: bladder temperature probe (Time Frame: 30 minutes after final dose of study drug has been administered) Secondary outcome measures: (1) Blood Pressure (systolic and mean arterial pressure) measured by intra‐arterial pressure monitor (Time Frame: 6 hourly during study treatment) (2) Liver function test (Time Frame: daily from first dose of study treatment to the 7th day) (3) Serum Paracetamol levels (blood analysis) after a single dose of study drug and after final dose of study drug. (Time Frame: baseline, 30, 45, 90, 240 minutes after single dose. 240 minutes after final dose of study drug) (4) Temperature (bladder and tympanic) (Time Frame: Hourly from first study drug treatment until 4 hours after final study drug treatment) (Time‐weighted mean, area under the 3‐day temperature curve, daily maximum and minimum temperature) (5) The use of physical cooling interventions (Time Frame: hourly during the period of study intervention) (6) Intracranial pressure (Time Frame: 6 hourly during the period of study intervention) (Mean daily intracranial pressure for day 1, 2 and 3.) (7) Incidence of cerebral hypoperfusion (Time Frame: During study intervention period) (8) Systolic blood pressure < 90 mmHg or Mean arterial pressure < 50 mmHg for > 15 minutes Cerebral perfusion pressure < 50 mmHg for > 15 minutes
Starting date	October 2010
Contact information	Manoj Saxena m.saxena@unsw.edu.au Parisa Glass pglass@george.org.au
Notes	As of 1 August 2014, the study has completed and the results will be included in the review within one year.