A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery

Inclusion Criteria: * Men or women, age 18 years or older. * Body weight \> or = to 100 pounds and \< or = 300 pounds. * Women of childbearing potential must have a negative serum pregnancy test result prior to entry into the study. * Able to provide written informed consent. * At least moderate pain as determined by a PI score of \> or = to 50 mm on a 100-mm VAS. * Willing and able to comply with all testing and requirements defined in the protocol. * Willing and able to complete the posttreatment visit. * Immediately prior to entering the study, surgical removal of 3 or 4 third molars (at least 1 mandibular partial bony or complete bony impaction). Exclusion Criteria: * Allergy or sensitivity to ketorolac or EDTA. * Allergic reaction to aspirin or other NSAIDs. * Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events (AEs). * Use of any IN product within 24 hours prior to study entry. * Clinically significant abnormality on screening laboratory tests. * History of cocaine use resulting in nasal mucosal damage. * Active peptic ulcer disease, recent (defined as within 6 months) history of peptic ulcer disease or gastrointestinal bleeding considered by the investigator to be clinically significant. * Advanced renal impairment (serum creatinine \>1.5 mg/dL) or a risk for renal failure due to volume depletion. * A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation. * Participation within 30 days of study entry or within 5 times the half- life, whichever is longer, in another investigational drug study. * Pregnancy or breastfeeding. * Extraction of teeth other than third molars during the surgical procedure; exceptions:(1) supernumerary third molars; (2) cases whereby extraction of a third molar requires the removal of an adjacent molar. * Previous participation in this study. * Use of any short-acting NSAID (such as aspirin or ibuprofen) or acetaminophen within 12 hours of surgery. * Use of longer-acting NSAIDs (such as naproxen sodium) within 48 hours of surgery or piroxicam within 7 days of surgery. * Use of steroids (other than oral contraceptives) within 72 hours of surgery. * Use of mood-altering drugs, such a cannabis or alcohol, within 12 hours of surgery. * Surgical anesthesia including narcotic agents except fentanyl. Short-acting anesthetics, both DEA scheduled and unscheduled, were allowed. Naloxone in any form was not permitted. * Use of any other medication within 24 hours prior to surgery that, in the opinion of the investigator, could confound the subject's efficacy assessments (eg, sedatives, tranquilizers, MAO inhibitors, phenothiazines). * Consumption of any caffeine-containing products within 4 hours of surgery.