A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.

Detailed Description
-----------------
Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED) for the treatment of moderate-to-severe pain. Ketorolac is available in both oral and parenteral forms and possess significant analgesic potency. However, ketorolac provides few advantages over other currently available analgesics and its use is limited by a virtue of having an analgesic ceiling with the dose being 10mg as well as having a range of severe side effects, of which gastrointestinal hemorrhage is most concerning.The concept of an analgesic ceiling is that doses beyond this value (10mg) do not provide additional analgesia and do contribute to side effects. In spite of this, the majority of research conducted on ketorolac in the ED and recommendations in Tintinalli's Emergency Medicine Textbook advocating for use of three-to-six fold higher dosages. Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.

Official Title
-----------------
A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management in the Emergency Department

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: 10 mg of Ketorolac
* Drug: 15 mg of Ketorolac
* Drug: 30 mg of Ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain. Exclusion Criteria: Age >65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - 10 mg of Ketorolac<br>Subjects will be administered 10 mg of Ketorolac for pain relief. | Drug: 10 mg of Ketorolac<br>* Patients will receive 10 mg of Ketorolac for pain control.<br>* Other names: Toradol;|
| Experimental: Group 2 - 15mg<br>Subjects will be administered 15mg of Ketorolac. | Drug: 15 mg of Ketorolac<br>* Patients will receive 15mg of Ketorolac for pain control.<br>* Other names: Toradol;|
| Experimental: Group 3 - 30mg<br>Subject will receive 30mg of Ketorolac as a part of standard care. | Drug: 30 mg of Ketorolac<br>* Patients will receive 30mg of Ketorolac for pain control.<br>* Other names: Toradol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score at 30 Minutes | Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effect of Dizziness | the number of study patients who reported having dizziness after administration of medication. | 120 minutes | 
| Adverse Effect of Nausea | The number of study patients who reported nausea after administration of medication | 120 minutes | 
| Adverse Effect of Headache | The number of study patients who reported headache after administration of medication | 120 minutes |