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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00406679
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : August 11, 2011
Information provided by:
Baxter Healthcare Corporation

Brief 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).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Paracetamol (acetaminophen) solution experimental Drug: paracetamol (acetaminophen) solution commercial Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00406679

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

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Responsible Party: Keyvan Tadjalli Mehr, MD, Baxter Healthcare Corporation Identifier: NCT00406679    
Other Study ID Numbers: R-01270-A015
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: August 2011
Keywords provided by Baxter Healthcare Corporation:
pain, postoperative
surgery, oral
surgery, dental
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs