Clinical trial NCT01356225: A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Dental Impaction
Keywords: pain following dental impaction surgery
Lead sponsor: Egalet Ltd
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Summed Pain Intensity Difference (SPID)
timeFrame: 8 hours postdose
Secondary outcomes:
measure: Summed Pain Intensity Difference (SPID)
timeFrame: 4 and 6 hours postdose
measure: Total Pain Relief (TOTPAR)
timeFrame: 4, 6, and 8 hours postdose
measure: Pain intensity difference (PID) and pain relief scores
timeFrame: Before receiving study drug (baseline), at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours postdose
measure: Peak PID score
timeFrame: 4, 6, and 8 hours postdose
measure: Peak pain relief scores
timeFrame: 4, 6, and 8 hours postdose
measure: Time to onset of perceptible pain and meaningful pain relief
timeFrame: After study drug administration until perceptible and meaningful pain relief was felt (during the 8-hour postdose observation period)
measure: Time to first use of rescue medication
timeFrame: After study drug administration until rescue analgesic therapy was requested (during the 8-hour postdose observation period)
measure: Proportion of subjects taking rescue medication
timeFrame: During 8-hour postdose observation period
measure: Global pain control
timeFrame: At the end of the 8-hour observation period, or at the time the subject took rescue analgesic medication if prior to 8 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Oral Surgery - PPD Development
state: Texas
Study officials:
affiliation: GloboMax (ICON plc)
name: Lincoln Bynum, MD
role: STUDY_CHAIR
References: