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

Phase 3

Completed

• Conditions: Acute Pain
• Interventions: Drug: Placebo; Drug: paracetamol

• Registration Number: NCT01586143
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Study Start: 2012-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	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.
transbuccal paracetamol 125 mg	paracetamol	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.

Primary Outcome Measures

Name	Time	Method
Pain score measured by visual analogue scale	at T0 + 120 minutes

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France