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

This study has been completed.
Information provided by:
Baxter Healthcare Corporation Identifier:
First received: November 29, 2006
Last updated: August 10, 2011
Last verified: August 2011

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 3

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:

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


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

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 identifier: NCT00406679

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
Study Director: Keyvan Tadjalli-Mehr, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Keyvan Tadjalli Mehr, MD, Baxter Healthcare Corporation 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
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses processed this record on April 23, 2014