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

This study has been completed.
Sponsor:
Collaborator:
Australian and New Zealand College of Anaesthetists
Information provided by:
University of Otago
ClinicalTrials.gov Identifier:
NCT00286650
First received: February 1, 2006
Last updated: February 2, 2006
Last verified: June 2004
  Purpose

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 Intervention Phase
Adult Patients Scheduled for 3rd Molar Teeth Extractions
Procedure: 3rd molar teeth extraction
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of Two Different Doses of Paracetamol for Post-Operative Pain Relief

Resource links provided by NLM:


Further study details as provided by University of Otago:

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

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

Estimated Enrollment: 18
Study Start Date: May 2005
Estimated Study Completion Date: October 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286650

Locations
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
Investigators
Principal Investigator: Mathew Zacharias, Dr Dunedin School of Medicine, Dunedin, New Zealand
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00286650     History of Changes
Other Study ID Numbers: Paracetamol
Study First Received: February 1, 2006
Last Updated: February 2, 2006
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by University of Otago:
Paracetamol

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014