The Paracetamol AfteR Traumatic Brain InjurY Study

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This primary aim is to investigate the effect of paracetamol in reducing body temperature in patients who have sustained traumatic brain injury. This study is also investigating the safety of paracetamol in this patient population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. M.K. Saxena
• Collaborators: Royal Brisbane and Women's Hospital; The George Institute; The University of New South Wales
• Treatments: Acetaminophen

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 or allergy to paracetamol

• Confirmed or suspected pregnancy

• Use of pharmacological or physical intervention that reduces body temperature in the 6-hour period prior to randomisation.

• Clinician decision to institute any pharmacological or physical intervention that modifies body temperature

• Body temperature at time of recruitment less that 36°C or greater than 38.9°C

• History of chronic liver disease or chronic alcohol abuse

• Suspected malnutrition: BMI < 18 kg/m2 or weight < 60 kg

• BMI > 35 kg/m2

• Renal failure with serum creatinine > 200

• Haemodynamic instability defined as systolic blood pressure < 90 mmhg or requirement for noradrenaline or adrenaline exceeding 20mcg/minute

• Use of hepatic enzyme inducers, except for phenytoin

• Minor head injury: either normal CT head or not expected to be in intensive care for 72 hours

• GCS = 3 with fixed dilated pupils

• Moribund patient expected to die within 24 hours