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 Clinical Trial

— PARAJUG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586143
• Other study ID #: CHU-0118
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2012
• Last updated: July 4, 2014
• Start date: May 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• 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.
• Placebo

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Bruno PEREIRA, Clinical Research Direction and innovation, Clermont-Ferrand Hospital, Dr Farès MOUSTAFA, Emergency Department, Clermont-Ferrand Hospital, Dr Gisèle PICKERING, Clinical Pharmacology Center, Inserm 501, Clermont-Ferrand Hospital, Pr Jeannot SCHIMDT, Emergency Department, Clermont-Ferrand Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score measured by visual analogue scale		at T0 + 120 minutes	Yes