Dosing of Ketorolac in the Emergency Department

Phase 4

Terminated

• Conditions: Acute Pain
• Interventions: Drug: Ketorolac

• Registration Number: NCT03464461
• Lead Sponsor: University of Missouri-Columbia

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.

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.

Study Timeline

• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Study Start: 2018-05-01
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Results First Submitted: 2024-09-19
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Results First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 289

Inclusion Criteria

> 18 y/o

Exclusion Criteria

pregnant allergic other contraindication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 mg	Ketorolac	10 mg ketorolac - low dose ketorolac
0 mg	Ketorolac	0 mg ketorolac - placebo
30 mg	Ketorolac	30 mg ketorolac - usual dose ketorolac

Primary Outcome Measures

Name	Time	Method
Difference of Pain Intensity Before and 30 Minute After Study Drug Administration in Participants With Any Pain Type	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	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	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	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	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.

Trial Locations

Locations (1)

University of Missouri Health Care; 🇺🇸 Columbia, Missouri, United States