Surgery Clinical Trial
Official title:
Analgesic Effect of Ibuprofen 400, 600 and 800 mg, Paracetamol 500 and 1000 mg, and Paracetamol 1000 mg Plus 60 mg Codeine: Single-dose, Randomized, Placebo-controlled and Double-blind Study on Acute Pain After Third Molar Surgery
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.
Status | Completed |
Enrollment | 350 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 30 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Ullevaal University Hospital | University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sum Pain Intensity Score(SPI) | 3 hour observation period | No | |
Secondary | Sum Pain Intensity Difference Score (SPID) | 3 hours | No | |
Secondary | Sum Pain Intensity Score (SPI) | 6 hours | No | |
Secondary | Sum Pain Intensity Difference Score (SPID) | 6 hours | No | |
Secondary | Maximum Pain Intensity Difference Score (MAXPID) | Unknown, calculated variable | No | |
Secondary | Time to Maximum Pain Intensity Difference Score | Unknown, calculated variable | No | |
Secondary | Self-reported Occurrence of Adverse Effects | 3 hours | Yes | |
Secondary | Self-reported Occurrence of Adverse Effects | 6 hours | Yes |
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