Paracetamol CSF Pharmacokinetics Study

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Despite its use for decades all over the world, the exact mechanism of action of paracetamol is not fully understood and essentially involves a combination of hypotheses. It is known to have an effect via the central nervous system, and of the many mechanisms proposed, one hypothesis is that it may have indirectly activate CB1 (cannabinoid) receptors, through its novel metabolite AM404.

This study aims to elucidate cerebrospinal levels of paracetamol and to measure the concentration of its metabolites, including AM404 in CSF. This may, in turn, give us useful information on the mechanism of action of paracetamol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barts & The London NHS Trust
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Adult subjects aged 18 to 80 years

• Subjects undergoing surgery who require a spinal anaesthetic and paracetamol as part of their routine anaesthetic plan

• Subjects with an American Society of Anesthesiology score of I-III

Exclusion Criteria:

• Subjects with any contraindication to spinal anaesthesia

• Subjects with known clotting abnormalities

• Pregnant or lactating women

• Subjects with known hypersensitivity to paracetamol

• Patients with severe hepatocellular insufficiency

• Patients already taking regular doses of paracetamol

• Any subjects deemed medically unsuitable by the investigator