Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED

Study Overview
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Brief Summary
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Hypothesis: Intravenous administration of Ketorolac 10 mg and 20 mg is as effective as 30 mg in treating renal colic pain in patients presenting to the emergency department

Detailed Description
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Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED). Because of the Ketorolac significant analgesic potency, it is usually used for moderate-to-severe pain. However, ketorolac has several side effects, of which gastrointestinal hemorrhage is most concerning. Analgesic ceiling is defined as the dose beyond which no additional analgesia can be achieved and on the other hand, more side effects might be encountered. Several studies suggested 10 mg as analgesic ceiling. Despite this, many recommendations are still advocating several folds higher doses (e.g. 30, 60 mg).

Official Title
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Comparison of Intravenous Ketorolac 10, 20, and 30mg for Treating Renal Colic Pain in the Emergency Department: A Randomized Controlled Trial

Conditions
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Pain, Renal Colic

Intervention / Treatment
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* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe flank and abdominal pain which pertains to renal colic according to emergency physician's gestalt Exclusion Criteria: Age >65 Active Peptic Ulcer disease Acute Gastrointestinal Hemorrhage Known History of Renal or Hepatic insufficiency History of allergies to NSAIDs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Dose escalation study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac 10mg<br>Subjects will be administered 10 mg of Ketorolac. | Drug: Ketorolac<br>* Subject will receive 10, 20, and 30mg of Ketorolac.<br>|
| Experimental: Ketorolac 20mg<br>Subjects will be administered 20 mg of Ketorolac | Drug: Ketorolac<br>* Subject will receive 10, 20, and 30mg of Ketorolac.<br>|
| Experimental: Ketorolac 30mg<br>As a part of standard care, subjects will be administered 30 mg of Ketorolac. | Drug: Ketorolac<br>* Subject will receive 10, 20, and 30mg of Ketorolac.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed with visual analogue scale (VAS) | The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity. | 30 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed with visual analogue scale (VAS) | The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity. | 15 Minutes | 
| Pain assessed with visual analogue scale (VAS) | The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity. | 45 Minutes | 
| Pain assessed with visual analogue scale (VAS) | The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity. | 60 Minutes | 
| Adverse Effects | Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect) | 60 Minutes |