Status:
COMPLETED
Analgesic Effect of Paracetamol, Paracetamol + Codeine, Ibuprofen and Their Combination
Lead Sponsor:
Ullevaal University Hospital
Collaborating Sponsors:
University of Oslo
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-30 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether the combination of paracetamol (acetaminophen) and other NSAIDs with or without weak opioids can give synergistic analgesic effect.
Detailed Description
Combining paracetamol and other NSAIDs could give a theoretical synergistic analgesic effect according to already known or assumed mechanisms of action. Synergism is defined as an additive or supra-ad...
Eligibility Criteria
Inclusion
- Patients of ASA class I in need of surgical removal of impacted third molars and with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars.
Exclusion
- Females stating not suspected or not verified pregnancy after being questioned by investigator.
- Patients who have used analgesics for 3 days prior to the day of surgery.
- Patients with known active gastrointestinal bleeding or ulcer.
- Patients with any known hypersensitivity to NSAIDs.
- Patients with other drug treatment than contraceptives.
- Patients smoking before taking the test-drug or during the observation period.
- Drug addicts or rehabilitated drug addicts.
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00921700
Start Date
June 1 2009
End Date
April 1 2015
Last Update
March 30 2016
Active Locations (1)
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1
Ullevaal University Hospital
Oslo, Norway, NO-0407