a single-dose study of intranasal ketorolac in the treatment of pain secondary to dental impaction surgery

Conditions: Pain; Dental Impaction

Summary: the purpose of this study is to evaluate the analgesic efficacy of a single intranasal (in) administration of ketorolac after dental impaction surgery.


Eligibility criteria:
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.

Keywords: pain following dental impaction surgery