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

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
paracetamol
Placebo
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Paracetamol by permucosal route,, Paracetamol by intraveinous route,, Pain., Patient with minor trauma of lower limb and/or superior limb (sprains, muscle contusions, …).

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

transbuccal paracetamol 125 mg

placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Pain score measured by visual analogue scale

Secondary Outcome Measures

Full Information

First Posted
April 10, 2012
Last Updated
July 4, 2014
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT01586143
Brief Title
Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Paracetamol by permucosal route,, Paracetamol by intraveinous route,, Pain., Patient with minor trauma of lower limb and/or superior limb (sprains, muscle contusions, …).

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transbuccal paracetamol 125 mg
Arm Type
Experimental
Arm 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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain score measured by visual analogue scale
Time Frame
at T0 + 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisele PICKERING
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26000668
Citation
Pickering G, Moustafa F, Macian N, Schmidt J, Pereira B, Dubray C. A New Transmucous-Buccal Formulation of Acetaminophen for Acute Traumatic Pain: A Non-inferiority, Randomized, Double-Blind, Clinical Trial. Pain Physician. 2015 May-Jun;18(3):249-57.
Results Reference
derived

Learn more about this trial

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

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