Comparison of Advil® and Tylenol® Extra Strength, separately and in combination, to alleviate postoperative dental pain

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2010
INTERVENTION: Subjects were randomly allocated to one of the 5 treatment groups: 1. 400mg Ibuprofen alone 2. 1000mg Acetaminophen alone 3. 400mg Ibuprofen plus 1000mg acetaminophen 4. 200mg Ibuprofen plus 500mg acetaminophen 5. Placebo CONDITION: Dental Pain ; Oral Health ; Other disorders of teeth and supporting structures PRIMARY OUTCOME: Sum of Pain Relief and Pain Intensity Differences from 0‐8 hours (SPRID 0‐8) SECONDARY OUTCOME: 1. Total Pain Relief from 0 to 8 hours (TOTPAR 0‐8); 2. Sum of the Pain Intensity Differences from 0 to 8 hours (SPID 0‐8) ; 3. Sum of the Pain Intensity Differences on the VAS scale from 0 to 8 hours (SPID VAS 0‐8); 4. TOTPAR, SPID, SPRID, and SPID VAS from 0 to 4 hours (0‐4) and 0 to 6 hours (0‐6); 5. Individual pain relief (PR) readings at each time point from 15 minutes to 8 hours; 6. Peak PR recorded during the 8‐hour evaluation period; 7. Individual PID at each time point from 15 minutes to 8 hours; 8. Individual PID for the VAS scale (PID VAS) at each time point from 15 minutes to 8 hours; 9. Peak PID and peak PID VAS recorded during the 8‐hour evaluation period; 10. First time at which the PID was at least 1; 11. Time to first perceptible pain relief; 12. Time to first confirmed perceptible pain relief; 13. Time to first meaningful pain relief; 14. Time to use of rescue medication; 15. Time to pain half gone; 16. Subject?s overall (global) assessment INCLUSION CRITERIA: 1. Age: between the ages of 16 and 40 years of age 2. Sex: either male or female 3. Primary diagnosis: At least three impacted third molars (two of which must have been mandibular impacted molars) indicated for removal. Both mandibular impactions must have required bone removal, and there must have been a total score of 9 or greater on the impaction grading scale for the three or four impacted third molar 4. Baseline Pain Intensity: were experiencing postoperative pain of at least moderate based on the pain intensity categorical rating scale and a pain intensity VAS score of 50mm or greater on the 100mm VAS Scale 5. Consent: gave written informed consent. Subjects who were 16 or 17 years of age also required their parents or legal guardian to provide written informed consent in addition to their written assent
Epistemonikos ID: 85f2b4e75a314e4aeaa9f8d1201983f72fed4865
First added on: Aug 22, 2024