Trial Outcomes & Findings for Dosing of Ketorolac in the Emergency Department (NCT NCT03464461)

Results Overview

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

289 participants

Primary outcome timeframe

30 minutes

Results posted on

2024-11-05

Participant Flow

Participants were excluded if they were giving medications that could interfere with study results, if study medication could not be administered, at the providers discretion, or if the participant decided to withdraw from the study. 31 participants signed consent but withdrew/were excluded before study drug administration 4 participants were excluded after study drug administration (see below)

Participant milestones

Participant milestones
Measure	0 mg 0 mg ketorolac - placebo Ketorolac: IV drug	10 mg 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug	30 mg 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug
Overall Study STARTED	83	92	83
Overall Study COMPLETED	82	89	83
Overall Study NOT COMPLETED	1	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	0 mg 0 mg ketorolac - placebo Ketorolac: IV drug	10 mg 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug	30 mg 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug
Overall Study exclusionary medication given ,	1	2	0
Overall Study Physician Decision	0	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0 mg n=82 Participants 0 mg ketorolac - placebo Ketorolac: IV drug	10 mg n=89 Participants 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug	30 mg n=83 Participants 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug	Total n=254 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 17 • n=82 Participants	44 years STANDARD_DEVIATION 16 • n=89 Participants	41 years STANDARD_DEVIATION 16 • n=83 Participants	43 years STANDARD_DEVIATION 16 • n=254 Participants
Sex: Female, Male Female	31 Participants n=82 Participants	51 Participants n=89 Participants	46 Participants n=83 Participants	128 Participants n=254 Participants
Sex: Female, Male Male	51 Participants n=82 Participants	38 Participants n=89 Participants	37 Participants n=83 Participants	126 Participants n=254 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	82 participants n=82 Participants	89 participants n=89 Participants	83 participants n=83 Participants	254 participants n=254 Participants
Baseline Pain Score	67.2 millimeters (mm) STANDARD_DEVIATION 15.1 • n=82 Participants	65.3 millimeters (mm) STANDARD_DEVIATION 15.6 • n=89 Participants	66.4 millimeters (mm) STANDARD_DEVIATION 16.7 • n=83 Participants	66.30 millimeters (mm) STANDARD_DEVIATION 21.39 • n=254 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: Patients presenting to the Emergency Department with pain that falls in one of the for categories: abdominal, headache, trauma/musculoskeletal, viral

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Outcome measures

Outcome measures
Measure	0 mg n=82 Participants 0 mg ketorolac - placebo Ketorolac: IV drug	10 mg n=89 Participants 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug	30 mg n=83 Participants 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type	15.1 mm Standard Deviation 18.5	15.6 mm Standard Deviation 19.4	16.7 mm Standard Deviation 20.7

PRIMARY outcome

Timeframe: 30 minutes

Population: Patients presenting to the Emergency Department with abdominal pain

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Outcome measures

Outcome measures
Measure	0 mg n=37 Participants 0 mg ketorolac - placebo Ketorolac: IV drug	10 mg n=46 Participants 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug	30 mg n=47 Participants 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain	12.4 mm Standard Deviation 16.5	19.4 mm Standard Deviation 19.9	22.1 mm Standard Deviation 21.0

PRIMARY outcome

Timeframe: 30 minutes

Population: Patients presenting to the Emergency Department with headache

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Outcome measures

Outcome measures
Measure	0 mg n=9 Participants 0 mg ketorolac - placebo Ketorolac: IV drug	10 mg n=4 Participants 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug	30 mg n=7 Participants 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache	13.3 mm Standard Deviation 14.8	10.8 mm Standard Deviation 8.7	11.1 mm Standard Deviation 18.4

PRIMARY outcome

Timeframe: 30 min

Population: Patients presenting to the Emergency Department with trauma/musculoskeletal pain

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Outcome measures

Outcome measures
Measure	0 mg n=24 Participants 0 mg ketorolac - placebo Ketorolac: IV drug	10 mg n=27 Participants 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug	30 mg n=19 Participants 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain	16.5 mm Standard Deviation 21.0	5.4 mm Standard Deviation 15.6	10.0 mm Standard Deviation 19.0

PRIMARY outcome

Timeframe: 30 min

Population: Patients presenting to the Emergency Department with viral pain

The outcome measure is the average change in pain score. Change in pain score is calculated for each participant by subtracting the post-treatment pain score from the pretreatment pain score (i.e. pre-treatment pain score minus post-treatment pain score), then averaging them within each group. The pain score is collected using the visual analog scale, which is a 100mm line that participants make a mark on to indicate their pain intensity. The line is then measured from the left end of the line to where the mark was made. The minimum value is 0mm (left end of the line) being no pain and the maximum value is 100mm (right end of the line) being the worst pain possible.

Outcome measures

Outcome measures
Measure	0 mg n=12 Participants 0 mg ketorolac - placebo Ketorolac: IV drug	10 mg n=12 Participants 10 mg ketorolac - low dose ketorolac Ketorolac: IV drug	30 mg n=10 Participants 30 mg ketorolac - usual dose ketorolac Ketorolac: IV drug
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain	21.8 mm Standard Deviation 19.3	25.4 mm Standard Deviation 17.5	8.4 mm Standard Deviation 15.7

Adverse Events

0 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

30 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthew Robinson

University of Missouri

Phone: 573 884-4400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place