Overview

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

Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baxter Healthcare Corporation
Treatments:
Acetaminophen
Analgesics
Pharmaceutical Solutions
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