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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406679
• Other study ID #: R-01270-A015
• Secondary ID: EudraCT2005-0055
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2006
• Last updated: August 10, 2011
• Start date: November 2006
• Est. completion date: October 2007

Study information

• Verified date: August 2011
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Paracetamol (acetaminophen) solution experimental
1 gm IV
• paracetamol (acetaminophen) solution commercial
1 gm IV
• placebo
equivalent volume IV 0.9% sodium chloride (equivalent volume)

Locations

Country	Name	City	State
United Kingdom	University Dental Hospital NHS Trust Cardiff	Cardiff	Wales
United Kingdom	University Dental Hospital of Manchester	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United Kingdom,