Acute PainPhase 4NCT03464461

Dosing of Ketorolac in the Emergency Department

A Phase 4 study testing Ketorolac in people with Acute Pain, run by University of Missouri-Columbia at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Pain
What is being tested?: Ketorolac
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 289 participants
Where: 1 siteUnited States
Study dates: 1 May 2018to 30 May 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

> 18 y/o

Who cannot join

pregnant allergic other contraindication

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Missouri Health Care
Columbia, Missouri, 65212

Other trials in United States

About this study

Official title: Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department

The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.

Read the detailed description

Patients from 4 groups will be treated with 3 different doses of ketorolac. The groups are 1. headache 2. abdominal pain 3. musculo-skeletal pain 4. viral syndrome. The doses will be 0, 10, 30mgs of ketorolac to clarify the placebo effect and the optimal dosage as a function of condition.

Conditions: Acute Pain
Being tested: Ketorolac
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KetorolacDrug
Also called Use of placebo, low, usual dose ketorolac
IV drug

Study groups in NCT03464461
Study group	Role	What they receive
0 mg	Placebo comparator	0 mg ketorolac - placebo Receives: Drug: Ketorolac
10 mg	Active comparator	10 mg ketorolac - low dose ketorolac Receives: Drug: Ketorolac
30 mg	Active comparator	30 mg ketorolac - usual dose ketorolac Receives: Drug: Ketorolac

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type
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.
Measured: 30 minutes
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants 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.
Measured: 30 minutes
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants 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.
Measured: 30 minutes
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants 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.
Measured: 30 min
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants 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.
Measured: 30 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201830 May 2024

First posted14 Mar 2018
Study start1 May 2018
Primary completion30 May 2024
Study completion30 May 2024

Why it stopped: Pandemic related supply shortages and slowed enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute PainStudies of the same condition, open and under way.
More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 4 groups with 3 different treatments
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 289 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03464461
Sponsor's protocol ID: 2010856
Status last verified: Oct 2024
First submitted: 7 Mar 2018
Last updated: 5 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Healthy Volunteers
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All Acute Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dosing of Ketorolac for Four Classes of Complaints in the Emergency Department
ClinicalTrials.gov ID: NCT03464461
Acronym / sponsor ID: 2010856
Conditions: Acute Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Pandemic related supply shortages and slowed enrollment.
Enrolment: 289 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Study start: 1 May 2018 (actual)
Primary completion: 30 May 2024 (actual)
Study completion: 30 May 2024 (actual)
First posted: 14 Mar 2018 (actual)
Results: Posted 5 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The optimal dose of ketorolac in the Emergency Department setting is no clear. We will compare 3 doses to determine the optimal dose.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3
Model description: 4 groups with 3 different treatments

Arm	Type	Receives
0 mg	Placebo comparator	Drug: Ketorolac0 mg ketorolac - placebo
10 mg	Active comparator	Drug: Ketorolac10 mg ketorolac - low dose ketorolac
30 mg	Active comparator	Drug: Ketorolac30 mg ketorolac - usual dose ketorolac

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

> 18 y/o

Key exclusion criteria (1 listed)

pregnant allergic other contraindication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KetorolacAlso: Use of placebo, low, usual dose ketorolacIV drug	Drug	0 mg, 10 mg, 30 mg

Primary outcome

Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type
Time frame: 30 minutes
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.
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain
Time frame: 30 minutes
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.
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache
Time frame: 30 minutes
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.
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain
Time frame: 30 min
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.
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Viral Pain
Time frame: 30 min
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.

Results and safety

Results posted to the registry on 5 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0 mg	83	82
10 mg	92	89
30 mg	83	83

Primary outcome: Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type

Time frame: 30 minutes. Mean (Standard Deviation). Unit: mm

Measure	0 mg n = 82	10 mg n = 89	30 mg n = 83
Value	15.1 (18.5)	15.6 (19.4)	16.7 (20.7)

0 mg vs 10 mg vs 30 mg: p = 0.9844, Kruskal-Wallis

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

Primary outcome: Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Abdominal Pain

Time frame: 30 minutes. Mean (Standard Deviation). Unit: mm

Measure	0 mg n = 37	10 mg n = 46	30 mg n = 47
Value	12.4 (16.5)	19.4 (19.9)	22.1 (21.0)

0 mg vs 10 mg vs 30 mg: p = 0.1580, Kruskal-Wallis

Population analysed: Patients presenting to the Emergency Department with abdominal pain

Primary outcome: Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Headache

Time frame: 30 minutes. Mean (Standard Deviation). Unit: mm

Measure	0 mg n = 9	10 mg n = 4	30 mg n = 7
Value	13.3 (14.8)	10.8 (8.7)	11.1 (18.4)

0 mg vs 10 mg vs 30 mg: p = 0.8730, Kruskal-Wallis

Population analysed: Patients presenting to the Emergency Department with headache

Primary outcome: Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Trauma/Musculoskeletal Pain

Time frame: 30 min. Mean (Standard Deviation). Unit: mm

Measure	0 mg n = 24	10 mg n = 27	30 mg n = 19
Value	16.5 (21.0)	5.4 (15.6)	10.0 (19.0)

0 mg vs 10 mg vs 30 mg: p = 0.0740, Kruskal-Wallis

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

Adverse events

Time frame: Approximately 40 minutes, from the time of consent until post-treatment pain score was obtained. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0 mg	0 of 82 (0%)	0 of 82 (0%)	0 of 82
10 mg	0 of 89 (0%)	0 of 89 (0%)	0 of 89
30 mg	0 of 83 (0%)	0 of 83 (0%)	0 of 83

Limitations and caveats (from the sponsor): Study enrollment ended early, resulting in less than half of the number of participants needed according to the power analysis. Our study site was closed to enrollment during the recent pandemic, and there was major supply chain issues for saline and IV equipment. Ultimately the study was closed due to the extenuating circumstances.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Acute Pain

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew Robinson, MD principal investigator

University of Missouri-Columbia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketorolac in people with Acute Pain, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type (time frame: 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03464461.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.