Paracetamol CSF Study Version 1

• Research type

  Research Study

• Full title

  A Single Centre Prospective Randomised Study to Investigate the Metabolism of Intravenous Paracetamol in Humans

• IRAS ID

  32186

• Contact name

  Vivek Mehta

• Sponsor organisation

  Joint Research Office, Barts and The London NHS Trust

• Eudract number

  2010-019488-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Paracetamol is a commonly used analgesic agent for peri-operative pain management. It forms the step 1 of the WHO Pain Ladder and constitutes an essential component of balanced analgesia to produce synergistic effects while reducing the need for opioid analgesics. Although it has been used orally since early 19th century, it has been recently formulated as a ready to use intravenous preparation in 2004. This new development is potentially beneficial to patients with an added advantage of 100% bioavailability and a relative ease of administration in intra- and post-operative period. There is evidence that when administered intravenously, paracetamol has a fast onset of action within 5-10 minutes with a peak analgesic action within 15 minutes.Although paracetamol has been used for decades there is relative little evidence about its CSF pharmacokinetics particularly after intravenous administration. Further the exact mechanism of action of paracetamol is not fully understood and essentially involves a combination of hypotheses. It is known to have a central effect perhaps by selective inhibiton of Prostaglandin H2 synthase. However it is hypothesised that it could also perhaps modulate the serotoninergic system and may have an indirect activation of CB1 (cannabinoid) receptors. The study aims to measure the CSF levels of paracetamol and its metabolites after it has been given intravenously. Patients who will be having spinal anaesthetics as part of their routine intra-operative care will be recruited.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/80

• Date of REC Opinion

  1 Nov 2010

• REC opinion

  Further Information Favourable Opinion