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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356225
• Other study ID #: ROX 2003-05
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2011
• Last updated: February 7, 2017
• Start date: February 2004

Study information

• Verified date: February 2017
• Source: Egalet Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Impaction
• Pain
• Tooth, Impacted

Intervention

Drug:
• Ketorolac tromethamine
30 mg Intranasal (2 x 100 uL of a 15% solution), single dose
• Placebo
IN placebo

Locations

Country	Name	City	State
United States	Austin Oral Surgery - PPD Development	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Egalet Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summed Pain Intensity Difference (SPID)	Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at 8 hours.	8 hours postdose
Secondary	Summed Pain Intensity Difference (SPID)	Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at 4 and 6 hours.	4 and 6 hours postdose
Secondary	Total Pain Relief (TOTPAR)	Scores were obtained from the pain relief evaluations by taking a weighted sum of pain relief scores. Pain relief was measured at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours on a 5-point categorical scale where 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.	4, 6, and 8 hours postdose
Secondary	Pain intensity difference (PID) and pain relief scores	Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. Pain relief was measured on a 5-point categorical scale with 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.	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
Secondary	Peak PID score	PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. Peak PID was defined as the maximum PID score.	4, 6, and 8 hours postdose
Secondary	Peak pain relief scores	Pain relief was measured on a 5-point categorical scale with 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief. Peak pain relief was defined as the maximum peak pain relief score.	4, 6, and 8 hours postdose
Secondary	Time to onset of perceptible pain and meaningful pain relief	The onset of pain relief was measured by the subjects stopping stopwatches when perceptible and meaningful relief was felt.	After study drug administration until perceptible and meaningful pain relief was felt (during the 8-hour postdose observation period)
Secondary	Time to first use of rescue medication	Duration of analgesia represented by the time until rescue analgesic therapy was requested.	After study drug administration until rescue analgesic therapy was requested (during the 8-hour postdose observation period)
Secondary	Proportion of subjects taking rescue medication	Proportion of subjects taking rescue medication in either group during the 8-hour postdose observation period.	During 8-hour postdose observation period
Secondary	Global pain control	The subject was asked the question "How was your pain control overall?" This evaluation was measured on a 5-point categorical scale with 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.	At the end of the 8-hour observation period, or at the time the subject took rescue analgesic medication if prior to 8 hours