Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous and rectal. The per-oral mucosal route is not used for the administration of paracetamol. It is a very interesting way for the rapid absorption of drugs such as nitrates used in angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows very rapid action. In addition, the oral administration-oral mucosa, less restrictive than IV administration and faster than oral administration, seek a single medical procedure unattended after dosing, will entail no pain or risk for infections the patient (in contrast to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the only dosage form of reference used by the IV route in the protocol "Pilot study Pharmacology paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by half permucosal to assess how changing the pharmacodynamics of the form permucosal to 125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual (under the pillar of the language) and compared with paracetamol in IV.
Crossover study, double-blind, randomized, controlled versus placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Change in pain threshold testing mechanical stimulation (von Frey electronic)
CHU Clermont-Ferrand
Clermont-Ferrand, France
Change in pain threshold testing mechanical stimulation (von Frey electronic)
Time frame: T0-5min, T0+3min, T0+7min, T0+15min, T0+30min, T0+50min, T0+90min
Evaluation of the acceptability of the permucosal product by the subject (evaluation questionnaire).
Time frame: T0+70min
Analysing a Sample of saliva for enzymatic determination (pharmacogenomics analysis)
Time frame: T0-10min
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