Back to resultsA Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery
Primary Purpose
Pain, Dental Impaction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketorolac tromethamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring pain following 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.
Sites / Locations
- Austin Oral Surgery - PPD Development
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intranasal Ketorolac tromethamine
Intranasal placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Time to first use of rescue medication
Duration of analgesia represented by the time until rescue analgesic therapy was requested.
Proportion of subjects taking rescue medication
Proportion of subjects taking rescue medication in either group during the 8-hour postdose observation period.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01356225
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Egalet Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Dental Impaction
Keywords
pain following dental impaction surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Ketorolac tromethamine
Arm Type
Experimental
Arm Title
Intranasal placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketorolac tromethamine
Intervention Description
30 mg Intranasal (2 x 100 uL of a 15% solution), single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IN placebo
Primary Outcome Measure Information:
Title
Summed Pain Intensity Difference (SPID)
Description
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.
Time Frame
8 hours postdose
Secondary Outcome Measure Information:
Title
Summed Pain Intensity Difference (SPID)
Description
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.
Time Frame
4 and 6 hours postdose
Title
Total Pain Relief (TOTPAR)
Description
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.
Time Frame
4, 6, and 8 hours postdose
Title
Pain intensity difference (PID) and pain relief scores
Description
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.
Time Frame
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
Title
Peak PID score
Description
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.
Time Frame
4, 6, and 8 hours postdose
Title
Peak pain relief scores
Description
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.
Time Frame
4, 6, and 8 hours postdose
Title
Time to onset of perceptible pain and meaningful pain relief
Description
The onset of pain relief was measured by the subjects stopping stopwatches when perceptible and meaningful relief was felt.
Time Frame
After study drug administration until perceptible and meaningful pain relief was felt (during the 8-hour postdose observation period)
Title
Time to first use of rescue medication
Description
Duration of analgesia represented by the time until rescue analgesic therapy was requested.
Time Frame
After study drug administration until rescue analgesic therapy was requested (during the 8-hour postdose observation period)
Title
Proportion of subjects taking rescue medication
Description
Proportion of subjects taking rescue medication in either group during the 8-hour postdose observation period.
Time Frame
During 8-hour postdose observation period
Title
Global pain control
Description
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.
Time Frame
At the end of the 8-hour observation period, or at the time the subject took rescue analgesic medication if prior to 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lincoln Bynum, MD
Organizational Affiliation
GloboMax (ICON plc)
Official's Role
Study Chair
Facility Information:
Facility Name
Austin Oral Surgery - PPD Development
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery
We'll reach out to this number within 24 hrs