The study is looking at the cerebrospinal fluid pharmacokinetics of intravenous paracetamol.
Conditions
Interventions
Trade Name: Perfalgan (Intravenous Paracetamol)
Product Name: Intravenous Paracetamol (trade name Perfalgan)
Product Code: N/A
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paraceta
Sponsors
Joint Research Office, Barts and The London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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 | — |
Countries
United Kingdom
Outcome results
None listed