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Comparison of Two Different Doses of Paracetamol for Post-Operative Pain Relief

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: NCT00286650
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : February 3, 2006
Australian and New Zealand College of Anaesthetists
Information provided by:
University of Otago

Brief Summary:
Paracetamol is commonly used to reduce pain after operations. Recently anaesthetists have been using bigger doses of paracetamol because it has been suggested that bigger doses will work better. However these bigger doses have never been assessed scientifically in adult patients to see if they work better, and it has not been determined at which dose the maximum effect in reducing pain occurs. We We will investigate whether a 90 mg per kg body weight dose works better than a 60 mg per kilogram dose, in reducing pain after wisdom tooth extraction. We will also examine the pharmacokinetics (the way the body removes the drug) of paracetamol, and whether paracetamol changes the way blood clots at these doses. We will also examine whether these doses are safe, by monitoring liver enzymes, and making sure the blood level of paracetamol is not greater than that previously recognised to cause liver disease. The patients will be healthy volunteers scheduled to have wisdom tooth extraction. They will have blood taken at intervals for four hours after having the paracetamol. They will fill in pain scores at the same times they have blood taken.

Condition or disease Intervention/treatment Phase
Adult Patients Scheduled for 3rd Molar Teeth Extractions Procedure: 3rd molar teeth extraction Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Two Different Doses of Paracetamol for Post-Operative Pain Relief
Study Start Date : May 2005
Study Completion Date : October 2005

Primary Outcome Measures :
  1. Any difference in effectiveness between the 2 dosage schedules

Secondary Outcome Measures :
  1. Any difference in safety between the 2 dosage schedules

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Eighteen healthy adults, male or female, aged 18 to 50 years scheduled for removal of bilateral, impacted, lower wisdom teeth will be recruited for the trial in the dental school.

Exclusion Criteria:

  • Intolerance to oral medication
  • Taking paracetamol and unable to abstain prior to the study
  • Hypersensitivity to paracetamol
  • Liver or renal failure
  • Pregnancy
  • Breast feeding
  • Poor nutritional status, eating disorder, or Body Mass Index (BMI) less than 16
  • Weight greater than 87 kg
  • Anticonvulsant medication
  • Chronic ethanol abuse
  • H/o bleeding disorders

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): NCT00286650

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New Zealand
School of Dentistry, University of Otago
Dunedin, Otago, New Zealand, 913
Sponsors and Collaborators
University of Otago
Australian and New Zealand College of Anaesthetists
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Principal Investigator: Mathew Zacharias, Dr Dunedin School of Medicine, Dunedin, New Zealand
Layout table for additonal information Identifier: NCT00286650    
Other Study ID Numbers: Paracetamol
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: February 3, 2006
Last Verified: June 2004
Keywords provided by University of Otago:
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations