Methods: Practitioner-investigators (55) enrolled N=2528 patients scheduled for a dental procedure that would have post-operative pain requiring either a recommendation by the dentist for an OTC or Rx analgesic medication. Prior to the procedure dentists rated the amount of anticipated pain that would be experienced by the patient and five days post operatively the patient was asked to give their own evaluation of their pain experience and effectiveness of the analgesic taken. The instrument used was a 5-point Likert scale.
Results: Median age of the patients was 51 (11-93); 42% male and 58% female with a diverse representative population. As per protocol a planned procedure was performed 98.5% of the time. The procedures are classified as: crown preparation (37.1%); pulp capping (1.5%); endodontic therapy (16%); periodontal surgery (12.2%); extraction (31.8%); abscess treatment (0.5%); onlay restoration (0.9%). OTC analgesic medications were predominately prescribed with the exception of periodontal surgery (56.7% Rx vs. 43.3% OTC) and extraction (66.4% Rx vs. 33.6% OTC). The highest percentage (23.4%) of days prescribed/recommended was five. The dentist and the patient agreed on the same level of pain 37.7% of the time. Rx (21%) vs. OTC (3.4%) patient-reported side effects differed by 17.6%. Patients who took the recommended OTC medications (59.5%) compared to those who took the prescribed medications (73%) differed by 13.5%. For all procedures severe and very severe pain accounted for 6.6%.
Conclusions: The data suggests that PEARL Network practitioners can add to the drug safety data base as proposed by the FDA. Clarification of OTC analgesic pharmacokinetics may reduce the number and use of prescribed analgesics. Supported by NIDCR U01-DE016755.