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Completed

NCT Number: NCT01586143

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About 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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol

Drug

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

Drug

Primary outcomes

  1. Pain score measured by visual analogue scale

    Time frame: at T0 + 120 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: PARAJUG

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2012
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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