Acute Pain
Conditions
Keywords
Paracetamol by permucosal route,, Paracetamol by intraveinous route,, Pain., Patient with minor trauma of lower limb and/or superior limb (sprains, muscle contusions, …).
Brief summary
This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
Detailed description
This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
Interventions
DRUGparacetamol
This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
DRUGPlacebo
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patient admitted to emergency departments with trauma of upper or lower limbs (sprains, muscle contusions,…) associated with intensity moderate of acute pain (VAS between 4 and 6) which require infusion IV of paracetamol 1g. * Patient takes any chronic treatment which considered incompatible with study. * Patient between 18 and 60. * Male or female. * Sufficient cooperation and understanding to comply to the requirements of study. * Acceptance to give a written consent. * Affiliation at system of French social security. * Inscription or acceptation of inscription at national register of voluntaries participant at research
Exclusion criteria
* Against paracetamol-indication: hypersensitivity known at paracétamol, antecedent hepatitis B or C, severe renal insufficiency and liver failure. * Patient with medical or surgical antecedents. * Patient with progressive disease at balance of inclusion. * Alcoholism suspicion or toxicomany at intake. * Patient who presents any inflammation or ulcerative pathology about buccal mucosa. * Patient who refuses to ingest alcohol for personal reasons. * Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman. * Patient who participated in another clinical trial, located in exclusion period or received benefits \> 4500 euros during 12 months before the beginning of trial. * Patient with cooperation and understanding insufficiency to comply to the requirements of protocol * Patient with social protection * No affiliation at system of French social security
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score measured by visual analogue scale | at T0 + 120 minutes |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGisele PICKERING
University Hospital, Clermont-Ferrand
Outcome results
None listed