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

NCT00286650 | Completed Phase 4

• 1 other identifier: Paracetamol
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Patients Scheduled for 3rd Molar Teeth Extractions

Keywords

Paracetamol

Outcome Measures

Primary Outcomes (1)

• Any difference in effectiveness between the 2 dosage schedules

Secondary Outcomes (1)

• Any difference in safety between the 2 dosage schedules

Interventions

3rd molar teeth extraction PROCEDURE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Otago: lead
• Australian and New Zealand College of Anaesthetists: collaborator

Study Sites (1)

School of Dentistry, University of Otago

Dunedin, Otago, 913, New Zealand

Location

Study Officials

• Mathew Zacharias, Dr

  Dunedin School of Medicine, Dunedin, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 3, 2006
• Study Start: May 1, 2005
• Study Completion: October 1, 2005
• Last Updated: February 3, 2006

Record last verified: 2004-06

Locations

NZ (1)