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

Egalet

Status and phase

Completed

Phase 2

Conditions

Dental Impaction

Pain

Treatments

Drug: Ketorolac tromethamine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01356225

ROX 2003-05

Details and patient eligibility

About

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

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.