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Trial Outcomes & Findings for Intramuscular Ketorolac at Two Single-Dose Regimens (NCT NCT04763876)

NCT ID: NCT04763876

Last Updated: 2025-10-15

Results Overview

The mean difference of Visual Analog Scale scores between the two treatment groups measured at 60-minutes. The Visual Analog Scale used measures from 0 mm to 100mm. A higher score represents more degree of change. 13 mm was used as the non-inferiority margin. A difference between the two groups less than 13 mm demonstrates that 15 mg is non-inferior to 60 mg.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

110 participants

Primary outcome timeframe

60 minutes from administration of medication

Results posted on

2025-10-15

Participant Flow

For the duration of our study, no study subjects were excluded or disenrolled.

Participant milestones

Participant milestones
Measure
15 mg Ketorolac Intramuscular
Patients who received a single 15 mg dose of ketorolac administered intramuscularly Ketorolac Injection 15 mg: A single dose of 15 mg ketorolac administered intramuscularly.
60 mg Ketorolac Intramuscular
Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly.
Overall Study
STARTED
55
55
Overall Study
COMPLETED
55
55
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
15 mg Ketorolac Intramuscular
n=55 Participants
Patients who received a single 15 mg dose of ketorolac administered intramuscularly Ketorolac Injection 15 mg: A single dose of 15 mg ketorolac administered intramuscularly.
60 mg Ketorolac Intramuscular
n=55 Participants
Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly.
Total
n=110 Participants
Total of all reporting groups
Age, Categorical
<=18 years
17 Participants
n=55 Participants
14 Participants
n=55 Participants
31 Participants
n=110 Participants
Age, Categorical
Between 18 and 65 years
38 Participants
n=55 Participants
41 Participants
n=55 Participants
79 Participants
n=110 Participants
Age, Categorical
>=65 years
0 Participants
n=55 Participants
0 Participants
n=55 Participants
0 Participants
n=110 Participants
Age, Continuous
31.1 years
n=55 Participants
30.7 years
n=55 Participants
30.9 years
n=110 Participants
Sex: Female, Male
Female
13 Participants
n=55 Participants
17 Participants
n=55 Participants
30 Participants
n=110 Participants
Sex: Female, Male
Male
42 Participants
n=55 Participants
38 Participants
n=55 Participants
80 Participants
n=110 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
55 participants
n=55 Participants
55 participants
n=55 Participants
110 participants
n=110 Participants
Weight in kilograms
82.8 kg
n=55 Participants
84.5 kg
n=55 Participants
83.7 kg
n=110 Participants
Duration of pain
69.8 minutes
n=55 Participants
66.3 minutes
n=55 Participants
68 minutes
n=110 Participants

PRIMARY outcome

Timeframe: 60 minutes from administration of medication

The mean difference of Visual Analog Scale scores between the two treatment groups measured at 60-minutes. The Visual Analog Scale used measures from 0 mm to 100mm. A higher score represents more degree of change. 13 mm was used as the non-inferiority margin. A difference between the two groups less than 13 mm demonstrates that 15 mg is non-inferior to 60 mg.

Outcome measures

Outcome measures
Measure
15 mg Ketorolac Intramuscular
n=55 Participants
Patients who received a single 15 mg dose of ketorolac administered intramuscularly Ketorolac Injection 15 mg: A single dose of 15 mg ketorolac administered intramuscularly.
60 mg Ketorolac Intramuscular
n=55 Participants
Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly.
Mean Difference of Visual Analog Scale Scores
-29.74 score on a scale
Standard Deviation 22.46
-29.85 score on a scale
Standard Deviation 23.14

SECONDARY outcome

Timeframe: 30 minutes from administration of medication

The mean difference of Visual Analog Scale scores between the two treatment groups measured at 30-minutes. The Visual Analog Scale used measures from 0 mm to 100mm. A higher score represents more degree of change. 13 mm was used as the non-inferiority margin. A difference between the two groups less than 13 mm demonstrates that 15 mg is non-inferior to 60 mg.

Outcome measures

Outcome measures
Measure
15 mg Ketorolac Intramuscular
n=55 Participants
Patients who received a single 15 mg dose of ketorolac administered intramuscularly Ketorolac Injection 15 mg: A single dose of 15 mg ketorolac administered intramuscularly.
60 mg Ketorolac Intramuscular
n=55 Participants
Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly.
Mean Difference of Visual Analog Scale Scores
-18.99 score on a scale
Standard Deviation 17.73
-17.31 score on a scale
Standard Deviation 18.31

SECONDARY outcome

Timeframe: At time of administration, 30 minutes after administration, and 60 minutes after administration.

The incidence of observed objective and reported subjective adverse events related to the administration of ketorolac.

Outcome measures

Outcome measures
Measure
15 mg Ketorolac Intramuscular
n=55 Participants
Patients who received a single 15 mg dose of ketorolac administered intramuscularly Ketorolac Injection 15 mg: A single dose of 15 mg ketorolac administered intramuscularly.
60 mg Ketorolac Intramuscular
n=55 Participants
Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly.
Number of Participants With Adverse Events Related to the Administration of Ketorolac
1 Participants
9 Participants

Adverse Events

15 mg Ketorolac Intramuscular

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

60 mg Ketorolac Intramuscular

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
15 mg Ketorolac Intramuscular
n=55 participants at risk
Patients who received a single 15 mg dose of ketorolac administered intramuscularly Ketorolac Injection 15 mg: A single dose of 15 mg ketorolac administered intramuscularly.
60 mg Ketorolac Intramuscular
n=55 participants at risk
Patients who received a single 60 mg dose of ketorolac administered intramuscularly Ketorolac Injection 60 mg: A single dose of 60 mg ketorolac administered intramuscularly.
Skin and subcutaneous tissue disorders
Burning at site of injection
0.00%
0/55 • 120 minutes
7.3%
4/55 • Number of events 4 • 120 minutes
Nervous system disorders
Fatigue
1.8%
1/55 • Number of events 1 • 120 minutes
3.6%
2/55 • Number of events 2 • 120 minutes
Nervous system disorders
Headache
0.00%
0/55 • 120 minutes
3.6%
2/55 • Number of events 2 • 120 minutes
Gastrointestinal disorders
Nausea
0.00%
0/55 • 120 minutes
1.8%
1/55 • Number of events 1 • 120 minutes

Additional Information

Nathaniel James Turner

William Beaumont Army Medical Center Department of Emergency Medicine

Phone: 915-742-6228

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place