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

Baxter

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Paracetamol (acetaminophen) solution experimental; Drug: placebo; Drug: paracetamol (acetaminophen) solution commercial

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406679

R-01270-A015

EudraCT2005-005575-14

Details and patient eligibility

About

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).

Enrollment: 135 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Paracetamol (acetaminophen) solution experimental

2

Placebo Comparator group

Treatment:

Drug: placebo

3

Active Comparator group

Treatment:

Drug: paracetamol (acetaminophen) solution commercial