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Acute Pain | Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain

Acute Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:paracetamolThis 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.

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

transbuccal paracetamol 125 mgThis 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.

placeboThis 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.

Study Status

Completed

Start Date: May 2012

Completed Date: May 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Pain score measured by visual analogue scale

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Gisele PICKERING

Lead Sponsor: University Hospital, Clermont-Ferrand

Collaborator: Dr Gisèle PICKERING, Clinical Pharmacology Center, Inserm 501, Clermont-Ferrand Hospital

More information:https://clinicaltrials.gov/show/NCT01586143

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