Status:
COMPLETED
Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain
Lead Sponsor:
Ullevaal University Hospital
Collaborating Sponsors:
University of Oslo
Conditions:
Surgery
Eligibility:
All Genders
18-30 years
Phase:
PHASE4
Brief Summary
The purpose of this placebo controlled clinical trial is to evaluate the dose response relationship of ibuprofen in doses from 400 mg to 800 mg and paracetamol (acetaminophen)in doses from 500 mg to 1...
Detailed Description
Acetaminophen (paracetamol) and related aspirin-like drugs have traditionally been used for pain control of minor to moderate postoperative pain. Gradually traditional non-steroidal anti-inflammatory ...
Eligibility Criteria
Inclusion
- Patients of both sexes referred for surgical removal of impacted third molars, due to symptoms or after being advised to do so by their dentist.
- Persons of both sexes (ASA type I).
- Females who are not pregnant or plan conception.
- Persons who have not used analgesics for 3 days prior to the day of surgery.
- Persons without known active ulcus or gastrointestinal bleeding.
- Persons without any known hypersensitivity for NSAIDs.
- Persons under no other continuous drug treatment than contraceptives.
- Caucasian origin.
- Persons with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars.
Exclusion
- Patients with surgery time exceeding 60 minutes
- Peroperative complications such as profuse bleeding or perforation to the maxillary sinus requiring additional drug treatment during or after the surgical removal of the third molar.
- Postoperative complications such as extended bleeding, nausea and regurgitation during the observation period.
- Smoking before taking the test-drug or during the observation period.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00699114
Start Date
June 1 2007
End Date
December 1 2009
Last Update
July 6 2011
Active Locations (1)
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1
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Oslo, Norway, N-0407