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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00286650
Registration number
NCT00286650
Ethics application status
Date submitted
1/02/2006
Date registered
3/02/2006
Date last updated
3/02/2006
Titles & IDs
Public title
Comparison of Two Different Doses of Paracetamol for Post-Operative Pain Relief
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Scientific title
Comparison of Two Different Doses of Paracetamol for Post-Operative Pain Relief
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Secondary ID [1]
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Paracetamol
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Adult Patients Scheduled for 3rd Molar Teeth Extractions
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Any difference in effectiveness between the 2 dosage schedules
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Any difference in safety between the 2 dosage schedules
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Otago
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Otago
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australian and New Zealand College of Anaesthetists
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00286650
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mathew Zacharias, Dr
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Address
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Dunedin School of Medicine, Dunedin, New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00286650
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