Trial Outcomes & Findings for An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain (NCT NCT01471639)
NCT ID: NCT01471639
Last Updated: 2025-08-15
Results Overview
Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
up to 4 hours
Results posted on
2025-08-15
Participant Flow
December 01, 2011 Emergency Department
Chronic pain, critical illness
Participant milestones
| Measure |
Intranasal Ketorolac (Sprix)
FDA approved drug used in single arm study
intranasal ketorolac: 15 mg
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
Baseline characteristics by cohort
| Measure |
Intranasal Ketorolac (Sprix)
n=37 Participants
FDA approved drug used in single arm study
intranasal ketorolac: 15 mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 4 hoursPopulation: Improvement in pain score rating among participants rating from baseline pain scores, 20 minutes, 40 minutes, 1 hour, 2 hour, 3 hour and 4 hour post dose. Pain scale ranging from 0 (no pain) - 10 (worst possible pain)
Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)
Outcome measures
| Measure |
Intranasal Ketorolac (Sprix)
n=37 Participants
FDA approved drug used in single arm study
intranasal ketorolac: 15 mg
|
|---|---|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · No Rating
|
37 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 10
|
10 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 9
|
2 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 8
|
12 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 7
|
5 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 6
|
5 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 5
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 4
|
2 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · REported Pain Score of 3
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 2
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 1
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · Reported Pain Score of 0
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
Baseline · No Rating
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 10
|
3 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 9
|
2 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 8
|
3 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 7
|
2 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 6
|
2 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 5
|
6 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 4
|
3 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · REported Pain Score of 3
|
4 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 2
|
5 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 1
|
3 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · Reported Pain Score of 0
|
4 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
20 minutes · No Rating
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 10
|
2 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 9
|
3 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 8
|
3 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 7
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 6
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 5
|
3 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 4
|
2 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · REported Pain Score of 3
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 2
|
4 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 1
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · Reported Pain Score of 0
|
6 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
40 minutes · No Rating
|
10 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 10
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 9
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 8
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 7
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 6
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 5
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 4
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · REported Pain Score of 3
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 2
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 1
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · Reported Pain Score of 0
|
3 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
1 hour · No Rating
|
29 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 10
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 9
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 8
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 7
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 6
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 5
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 4
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · REported Pain Score of 3
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 2
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 1
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · Reported Pain Score of 0
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
2 hoiurs · No Rating
|
36 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 10
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 9
|
1 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 8
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 7
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 6
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 5
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 4
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · REported Pain Score of 3
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 2
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 1
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · Reported Pain Score of 0
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
3 hours · No Rating
|
36 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 10
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 9
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 8
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 7
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 6
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 5
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 4
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · REported Pain Score of 3
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 2
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 1
|
0 Participants
|
|
Efficacy of Intranasal Ketorolac on Numeric Pain Scale
4 hours · Reported Pain Score of 0
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 hoursPopulation: Participants who reported discomfort or unpleasant feeling associated with use of intranasal ketorolac
Safety assessed by reporting of all adverse events and side effects.
Outcome measures
| Measure |
Intranasal Ketorolac (Sprix)
n=37 Participants
FDA approved drug used in single arm study
intranasal ketorolac: 15 mg
|
|---|---|
|
Adverse Event/Side Effects
Reported a "burning" feeling
|
7 Participants
|
|
Adverse Event/Side Effects
No adverse event/Side effect reported
|
30 Participants
|
Adverse Events
Intranasal Ketorolac (Sprix)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Ketorolac (Sprix)
n=37 participants at risk
FDA approved drug used in single arm study
intranasal ketorolac: 15 mg
|
|---|---|
|
Skin and subcutaneous tissue disorders
Discomfort (burning feeling of nasal mucosa)
|
18.9%
7/37 • Number of events 7 • 7 months
Definition same as Clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place