Ibuprofen and Acetaminophen Versus Intranasal Ketorolac (Sprix) in an Untreated Endodontic Pain Model: A Randomized, Double-blind Investigation.

ABSTRACT

INTRODUCTION: Previously, ketorolac was available for primary use only via intravenous and intramuscular routes. Its availability in intranasal form offers an alternative route of administration that patients can self-administer. The purpose of this study was to compare the efficacy of intranasal ketorolac (Sprix; Egalet US Inc, Wayne, PA) with a combination of ibuprofen/acetaminophen in an acute pain model of untreated endodontic patients experiencing moderate to severe pain and symptomatic apical periodontitis. METHODS: Seventy patients experiencing moderate to severe pain, a pulpal diagnosis of symptomatic irreversible pulpitis or necrosis, and a periapical diagnosis of symptomatic apical periodontitis participated. Patients were randomly divided into 2 groups and received either 31.5 mg intranasal ketorolac and placebo capsules or 1000 mg acetaminophen/600 mg ibuprofen capsules and a mock nasal spray. Patients recorded perceived pain scores on a visual analog scale every 15 minutes from drug administration up to 240 minutes. The time to 50% pain relief, the first sign of pain relief, and meaningful pain relief were recorded, and the data were analyzed. RESULTS: A decline in reported pain was observed until 120 minutes after dosing, after which reported pain remained relatively constant. There was no significant difference between the 2 groups for the time to 50% pain relief, the first sign of pain relief, or meaningful pain relief. CONCLUSIONS: The effectiveness of intranasal ketorolac was not significantly different from that of a 1000 mg acetaminophen/600 mg ibuprofen combination. Intranasal ketorolac provides a nonnarcotic alternative and an additional route of medication administration to practicing clinicians.