Dental Pain Oral Health Other disorders of teeth and supporting structures
Conditions
Interventions
Subjects were randomly allocated to one of the 5 treatment groups:
1. 400mg Ibuprofen alone
2. 1000mg Acetaminophen alone
3. 400mg Ibuprofen plus 1000mg
Sponsors
Reckitt Benckiser Healthcare (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Had a current history of significant disease deemed by the investigator to render the subject unsuitable for inclusion 2. Had any ongoing painful condition other than that associated with their third molar surgery 3. Had an ongoing condition that may have interfered with the absorption, distribution, metabolism or excretion of the study drug 4. Had a history of allergy (including angioedema, urticaria, bronchospasm and rhinitis) related to the treatment with ibuprofen, acetaminophen, aspirin, other NSAIDs or any other medication used in this study 5. A history of frequent peptic ulcers, duodenal ulcers or GI bleeding 6. A history of frequent dyspepsia, heartburn or indigestion 7. A history of migraine headaches within the past year 8. A history of psychotic illness, attempted suicide or neurosis 9. Those unable to refrain from smoking during their stay in the research centre 10. A positive history of drug or alcohol abuse within the past six months 11. Those who were taking any concomitant medication that might have confounded assessments of pain relief (PAR), such as: psychotropic drugs, antidepressants, sedative-hypnotics (other than those permitted for conscious sedation), or other analgesics taken within five times of their elimination half lives. Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs) were permitted if the subject had been on a stable dose for at least four weeks prior to visit 1 (screening) 12. Those who were unable, in the opinion of the investigator, to comply fully with the study requirements 13. Those previously randomised into this study 14. Those who had participated in a clinical trial in the previous 12 weeks. Twelve weeks (calculated from the time of last dosing in the prior trial to time of anticipated dosing in this trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of Pain Relief and Pain Intensity Differences from 0-8 hours (SPRID 0-8) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States of America
Outcome results
None listed