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

This study has been completed.
Sponsor:
Collaborators:
Dr Gisèle PICKERING, Clinical Pharmacology Center, Inserm 501, Clermont-Ferrand Hospital
Pr Jeannot SCHIMDT, Emergency Department, Clermont-Ferrand Hospital
Dr Farès MOUSTAFA, Emergency Department, Clermont-Ferrand Hospital
Bruno PEREIRA, Clinical Research Direction and innovation, Clermont-Ferrand Hospital
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01586143
First received: April 10, 2012
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Acute Pain
Drug: paracetamol
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Pain score measured by visual analogue scale [ Time Frame: at T0 + 120 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: May 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transbuccal paracetamol 125 mg
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.
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 Comparator: 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.
Drug: Placebo

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586143

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Dr Gisèle PICKERING, Clinical Pharmacology Center, Inserm 501, Clermont-Ferrand Hospital
Pr Jeannot SCHIMDT, Emergency Department, Clermont-Ferrand Hospital
Dr Farès MOUSTAFA, Emergency Department, Clermont-Ferrand Hospital
Bruno PEREIRA, Clinical Research Direction and innovation, Clermont-Ferrand Hospital
Investigators
Principal Investigator: Gisele PICKERING University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01586143     History of Changes
Other Study ID Numbers: CHU-0118
Study First Received: April 10, 2012
Last Updated: July 4, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Paracetamol by permucosal route,
Paracetamol by intraveinous route,
Pain.
Patient with minor trauma of lower limb and/or superior limb (sprains, muscle contusions, …).

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014