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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

Scientific title

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

Secondary ID [1]

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

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Any difference in effectiveness between the 2 dosage schedules

Timepoint [1]

Secondary outcome [1]

Any difference in safety between the 2 dosage schedules

Timepoint [1]

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]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Primary sponsor type

Other

Name

University of Otago

Address

Country

Other collaborator category [1]

Other

Name [1]

Australian and New Zealand College of Anaesthetists

Address [1]

Country [1]

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/study/NCT00286650

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mathew Zacharias, Dr

Address

Dunedin School of Medicine, Dunedin, New Zealand

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

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

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00286650