Pain
Conditions
Keywords
mechanism of action of paracetamol in the brain structures
Brief summary
Paracetamol is one of the most widely used analgesic in the world, indicated for the symptomatic treatment of fever and pain. The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation.
Detailed description
Visit 1 / Visit 2 Inclusion of the subject, Clinical examination Trainings tests Study period 1 Clinical examination Measurement of the basal pain thresholds Administration of product (T0) T0+100min : Thermal stimulation according to the established paradigm and fMRI data acquisition T0+180min : Thermal stimulation according to the established paradigm and fMRI data acquisition Study period 2: same of period 1.
Interventions
The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation
Sponsors
Dr. Gisèle PICKERING (MCU, PH)
Dr. Betty JEAN (PH)
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* \- Healthy volunteers * Aged at last 18 years and over 60 years * Male * Non-smoking subject * Fasting coffe, tea, coca-cola or other stimulant products since the last evening * Subject free of any treatment within 7 days prior to inclusion including no use of analgesics or anti-inflammatory treatments
Exclusion criteria
* Contraindications to the administration of paracetamol * Contraindications to the completion of MRI * Medical history and/or surgical judged by the investigator as being incompatible with the test * Progressive disease at the inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 100 min after administration of paracetamol or placebo in brain structures | 100 min after administration of paracetamol or placebo |
Secondary
| Measure | Time frame |
|---|---|
| Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 180 min after administration of paracetamol or placebo in brain structures | 180 min after administration of paracetamol or placebo |
Countries
France
Outcome results
None listed