Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
The surgical placement of dental implants is presently a common procedure performed by oral
surgeons, periodontists, and general dentists. The surgery can be performed under local
anesthesia and involves the incision of soft tissue to expose the underlying bone,
preparation of the implant site using a specialized surgical drill, and.screwing the implant
into bone using a specialized headpiece. Dental implant patients experience postoperative
pain yet there are no studies in the literature which have evaluated the efficacy of
analgesics in this patient population. The current pilot study will evaluate the analgesic
effects and tolerability of a recently FDA-approved analgesic formulation of intranasal
ketorolac (SPRIX®) in 25 patients who have 1 - 3 dental implants surgically placed. Patients
will self administer the ketorolac nasal spray (one spray in each nostril, 31.5 mg total
dose) when their postoperative pain reaches at least a moderate severity. Pain intensity and
pain relief scores will then be recorded every 20 minutes for the first hour, at 1.5 and 2
hours and then hourly through 6 hours on a validated analgesic diary. Side effects will be
recorded when and if they occur. Patients will then transition to a multi-dose phase where
they will be allowed to dose with ketorolac as indicated in the package insert (up to 4 times
per day for 5 days). Patients will record the time of each dose, a daily assessment of
overall efficacy and side effects, and the use of any rescue medication (acetaminophen 650
mg) on a take home diary.