Clinical trial NCT01586143: Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain
Official title: Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Keywords: Paracetamol by permucosal route,
Paracetamol by intraveinous route,
Pain.
Patient with minor trauma of lower limb and/or superior limb (sprains, muscle contusions, …).
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score measured by visual analogue scale
timeFrame: at T0 + 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisele PICKERING
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pickering G, Moustafa F, Macian N, Schmidt J, Pereira B, Dubray C. A New Transmucous-Buccal Formulation of Acetaminophen for Acute Traumatic Pain: A Non-inferiority, Randomized, Double-Blind, Clinical Trial. Pain Physician. 2015 May-Jun;18(3):249-57.