Do the post operative nausea and vomiting (PONV) drugs Granisetron and Ondansetron negate the analgesic effects of Paracetamol?
Do the post operative nausea and vomiting (PONV) drugs Granisetron and Ondansetron negate the analgesic effects of Paracetamol in healthy male volunteers?
Dr Paul Sherwin
40 participants
Oct 20, 2009
Interventional
Conditions
Summary
12/11/2009. A pilot study checking the sensitivity of the Painmatcher is currently underway. This involves 20 healthy male volunteers who are randomised to receive either 100mls Normal Saline intravenously or 1g Paracetamol intravenously in a blinded crossover fashion. Pain thresholds are checked using the PainMatcher at T0, T30, T60, T120, T180, T240. Each volunteer has been trained four times prior to the first clinical session in the use of the PainMatcher. 18/07/2010. The pilot study has now been completed.
Eligibility
Inclusion Criteria1
- Healthy male volunteers aged 18 to 55 years
Exclusion Criteria1
- Female, minors, known hypersensitivity to one of the drugs, excessive caffeine consumption (> 4 cups coffee per day), excessive cigarette smoking, illicit drugs, concomitant use of prescription medication
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Interventions
Volunteers will be cannulated and a baseline pain threshold measured using a "PainMatcher". Volunteers will receive either Granisetron 1mg intravenously (iv), ondansetron 4mg intravenously (iv) or 5mls normal saline intravenously (iv) (placebo). 30 minutes later (time T 0) pain threshold will be measured followed by administration of paracetamol 1g intravenously (iv) and decannulation. Pain thresholds will be measured at T30, T60, T120, T180 and T240 using the "PainMatcher". The trial is fully randomised and double blinded. Each volunteer will attend 3 clinical sessions spaced one week apart so that they receive all three medications in a crossover fashion.
Locations(1)
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ACTRN12609000915257