None listed
Conditions
Brief 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.
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
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.
Sponsors
Dr Paul Sherwin
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male volunteers aged 18 to 55 years
Exclusion criteria
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
Outcome results
None listed