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

This study has been completed.

First Received on November 29, 2006. Last Updated on August 10, 2011 History of Changes

Sponsor:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00406679

Purpose

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).

Condition	Intervention	Phase
Pain, Postoperative	Drug: Paracetamol (acetaminophen) solution experimental Drug: paracetamol (acetaminophen) solution commercial Drug: placebo	Phase III

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

Resource links provided by NLM:

Drug Information available for: Chlorides Acetaminophen CT 2584 Sodium chloride

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Enrollment:	135
Study Start Date:	November 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Paracetamol (acetaminophen) solution experimental 1 gm IV Other Names: paracetamol acetaminophen
Placebo Comparator: 2	Drug: placebo equivalent volume IV 0.9% sodium chloride (equivalent volume) Other Names: sodium chloride saline
Active Comparator: 3	Drug: paracetamol (acetaminophen) solution commercial 1 gm IV Other Names: paracetamol acetaminophen

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406679

Locations

United Kingdom
University Dental Hospital of Manchester
Manchester, England, United Kingdom
University Dental Hospital NHS Trust Cardiff
Cardiff, Wales, United Kingdom

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Study Director:

Keyvan Tadjalli-Mehr, MD

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Keyvan Tadjalli Mehr, MD, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00406679 History of Changes
Other Study ID Numbers:	R-01270-A015, EudraCT2005-005575-14
Study First Received:	November 29, 2006
Last Updated:	August 10, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Baxter Healthcare Corporation:

pain, postoperative
surgery, oral
surgery, dental

Additional relevant MeSH terms:

Pain, Postoperative
Toothache
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Acetaminophen

Analgesics
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012