Comparison of Two Different Doses of Paracetamol for Post-Operative Pain Relief
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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 |
- Any difference in effectiveness between the 2 dosage schedules
- 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 |
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| New Zealand | |
| School of Dentistry, University of Otago | |
| Dunedin, Otago, New Zealand, 913 | |
| 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 Postoperative Complications Pathologic Processes Pain Signs and Symptoms Acetaminophen Antipyretics Physiological Effects of Drugs |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013