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

Baxter Healthcare Corporation2 sites in 1 country135 target enrollmentNovember 2006

ConditionsPain, Postoperative

Interventionsparacetamol (acetaminophen) solution commercial Paracetamol (acetaminophen) solution experimental placebo

DrugsParacetamol (acetaminophen) solution experimental paracetamol (acetaminophen) solution commercial placebo

Overview

Phase: Phase 3
Intervention: paracetamol (acetaminophen) solution commercial
Conditions: Pain, Postoperative
Sponsor: Baxter Healthcare Corporation
Enrollment: 135
Locations: 2
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

October 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

Eligibility 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