Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 1000 mg compared with paracetamol (acetaminophen)1000 mg plus codeine 60 mg on acute postoperative pain after surgical removal of impacted third molars.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ullevaal University Hospital
• Collaborator: University of Oslo
• Treatments: Acetaminophen; Analgesics; Codeine; Ibuprofen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.