Dosing of Ketorolac in the Emergency Department

NCT03464461 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2010856
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  30 min

Study Arms (3)

0 mg

PLACEBO COMPARATOR

0 mg ketorolac - placebo

Drug: Ketorolac

10 mg

ACTIVE COMPARATOR

10 mg ketorolac - low dose ketorolac

Drug: Ketorolac

30 mg

ACTIVE COMPARATOR

30 mg ketorolac - usual dose ketorolac

Drug: Ketorolac

Interventions

Ketorolac DRUG

IV drug

Also known as: Use of placebo, low, usual dose ketorolac

0 mg; 10 mg; 30 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 y/o

You may not qualify if:

• pregnant allergic other contraindication

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Matthew Robinson
• Organization: University of Missouri

robinsonmt@health.missouri.edu

573 884-4400

Study Officials

• Matthew Robinson, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: blinded drug
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 4 groups with 3 different treatments

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: May 1, 2018
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Locations

US (1)