Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Dental Pain
Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Paracetamol (acetominophen) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Baxter Healthcare Corporation Official(s) and/or principal investigator(s):
Jocelyne Flament, MD, Study Director, Affiliation: Baxter Healthcare Corporation
Summary
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).
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Cardiff, Cardiff CF14 4XY, United Kingdom
University Dental Hospital of Manchester, Manchester M15 6FH, United Kingdom
Additional Information
Starting date: November 2006
Ending date: October 2007
Last updated: October 15, 2007
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