A double-blind placebo-controlled four period crossover study of paracetamol and tramadol in the electrical hyperalgesia model of central sensitisation in healthy volunteers

INTERVENTION: Trade Name: Perfalgan Product Name: Perfalgan Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Paracetamol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Trade Name: Tramal Product Name: Tramal Pharmaceutical Form: Solution for injection INN or Proposed INN: Tramadol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use CONDITION: The primary aim of the present study is to investigate the effects of intravenous paracetamol and tramadol and their combination on the experimentally‐induced central sensitization in an electrical hyperagesia model, using dosing regimens utilised in the clinic in a double‐blind, placebo‐controlled and ramdomized cross‐over design. PRIMARY OUTCOME: Main Objective: To investigate the effects of intravenous paracetamol and tramadol on the areas of hyperalgesia and allodynia in an electrical hyperalgesia model in healthy volunteers. Primary end point(s): Primary end points are areas of pin‐prick hyperalgesia (260nM vonFrey filament) and areas of touch‐evoked allodynia (stroking by cotton wool tip) Secondary Objective: To investigate the effects of intravenous paracetamol and tramadol on pain and flare in an electrical hyperalgesia model in healthy volunteers. INCLUSION CRITERIA: healthy volunteers, male and female, age 18‐45 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) no F.1.3.1 Number of subjects for this age range