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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Comparison of Two Different Doses of Paracetamol for Post-Operative Pain Relief
Secondary ID [1] 0 0
Paracetamol
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Patients Scheduled for 3rd Molar Teeth Extractions 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - 3rd molar teeth extraction

Treatment: Surgery: 3rd molar teeth extraction
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Any difference in effectiveness between the 2 dosage schedules
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Any difference in safety between the 2 dosage schedules
Timepoint [1] 0 0

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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otago

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand College of Anaesthetists
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00286650
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mathew Zacharias, Dr
Address 0 0
Dunedin School of Medicine, Dunedin, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00286650