Laparoscopic Cholecystectomy
Conditions
Keywords
paracetamol, acetaminophen, pharmacokinetic, intravenous, oral, analgesia, pain, opioid
Brief summary
To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs.
Interventions
Sponsors
Melbourne Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18-75 * Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia
Exclusion criteria
* Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available. * History of allergy or sensitivity to paracetamol * Administration of oral paracetamol within previous 8 hours * American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity * Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol. | — |
Countries
Australia
Outcome results
None listed