A Single Centre Prospective Randomised Study to Investigate the Metabolism of Intravenous Paracetamol in Humans - Paracetamol CSF Study Version 1
- Conditions
- The study is looking at the cerebrospinal fluid pharmacokinetics of intravenous paracetamol.
- Registration Number
- EUCTR2010-019488-12-GB
- Lead Sponsor
- Joint Research Office, Barts and The London NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Adult patients aged 18 and 80 years from whom full written informed consent will be sought.
Patients undergoing surgery who require a spinal anaesthetic and paracetamol as part of their routine anaesthetic
Patients who fall into the American Society of Anesthesiologists scoring system of ASA I-III.
Patients with no known clotting abnormalities
Patients who have given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients with any contraindication to spinal anaesthesia
Patients with known clotting abnormalities.
Pregnant women.
Patients who have known hypersensitivity to paracetamol.
Any patients who are deemed unsuitable by the investigators due to medical reasons.
Subjects who have received an investigational drug or have used an investigational device in the 30 days preceding to study entry.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the distribution of intravenous paracetamol within the body, in particular the penetration from blood into the fluid surrounding the spinal cord. ;Secondary Objective: To measure the effect of intravenous paracetamol on prostaglandins (mediators involved in inflammation in the body).<br>To measure the concentration of AM404 (a metabolite of paracetamol which prevents the reuptake of cannabinoids). This may provide more information on the mechanism of action of paracetamol. ;Primary end point(s): The cerebrospinal levels of paracetamol post administration of intravenous paracetamol
- Secondary Outcome Measures
Name Time Method