Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00406679
First received: November 29, 2006
Last updated: August 10, 2011
Last verified: August 2011

November 29, 2006
August 10, 2011
November 2006
October 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00406679 on ClinicalTrials.gov Archive Site
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Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain
Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Dental Pain Model

The aim of the study is to evaluate the therapeutic efficacy and safety of two different paracetamol-containing solutions in postoperative dental pain. They will be compared to placebo (a dummy treatment which contains no active ingredient).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain, Postoperative
  • Drug: Paracetamol (acetaminophen) solution experimental
    1 gm IV
    Other Names:
    • paracetamol
    • acetaminophen
  • Drug: paracetamol (acetaminophen) solution commercial
    1 gm IV
    Other Names:
    • paracetamol
    • acetaminophen
  • Drug: placebo
    equivalent volume IV 0.9% sodium chloride (equivalent volume)
    Other Names:
    • sodium chloride
    • saline
  • Experimental: 1
    Intervention: Drug: Paracetamol (acetaminophen) solution experimental
  • Placebo Comparator: 2
    Intervention: Drug: placebo
  • Active Comparator: 3
    Intervention: Drug: paracetamol (acetaminophen) solution commercial
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA I or II and scheduled for elective surgical extraction of 1 or more impacted mandibular 3rd molars, at least 1 of which must be a fully or partially impacted mandibular 3rd molar requiring mandibular bone removal.
  • Moderate or severe pain within 4 hours after the completion of surgery.

Exclusion Criteria:

  • Another acute or chronic painful physical condition
  • Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
  • Inability to use and understand Visual Analog Scale and Verbal Rating Score
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00406679
R-01270-A015, EudraCT2005-005575-14
No
Keyvan Tadjalli Mehr, MD, Baxter Healthcare Corporation
Baxter Healthcare Corporation
Not Provided
Study Director: Keyvan Tadjalli-Mehr, MD Baxter Healthcare Corporation
Baxter Healthcare Corporation
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP