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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - 10 mg of Ketorolac | Experimental | Subjects will be administered 10 mg of Ketorolac for pain relief. |
|
| Group 2 - 15mg | Experimental | Subjects will be administered 15mg of Ketorolac. |
|
| Group 3 - 30mg | Experimental | Subject will receive 30mg of Ketorolac as a part of standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 mg of Ketorolac | Drug | Patients will receive 10 mg of Ketorolac for pain control. |
|
| 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 |
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sergey Motov, MD | Attending | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8655940 | Background | Catapano MS. The analgesic efficacy of ketorolac for acute pain. J Emerg Med. 1996 Jan-Feb;14(1):67-75. doi: 10.1016/0736-4679(95)02052-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - 10 mg of Ketorolac | Subjects will be administered 10 mg of Ketorolac for pain relief. 10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control. |
| FG001 | Group 2 - 15mg | Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control. |
| FG002 | Group 3 - 30mg | Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - 10 mg of Ketorolac | Subjects will be administered 10 mg of Ketorolac for pain relief. 10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control. |
| BG001 | Group 2 - 15mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | pain score | 30 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - 10 mg of Ketorolac | Subjects will be administered 10 mg of Ketorolac for pain relief. 10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sergey Motov | Maimonides Medical Center | 718-283-8693 | smotov@maimonidesmed.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 15 mg of Ketorolac | Drug | Patients will receive 15mg of Ketorolac for pain control. |
|
|
| 30 mg of Ketorolac | Drug | Patients will receive 30mg of Ketorolac for pain control. |
|
|
| 120 minutes |
| Adverse Effect of Headache | The number of study patients who reported headache after administration of medication | 120 minutes |
Subjects will be administered 15mg of Ketorolac.
15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.
| BG002 | Group 3 - 30mg | Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Group 3 - 30mg | Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control. |
|
|
| Secondary | Adverse Effect of Dizziness | the number of study patients who reported having dizziness after administration of medication. | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Adverse Effect of Nausea | The number of study patients who reported nausea after administration of medication | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Adverse Effect of Headache | The number of study patients who reported headache after administration of medication | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Group 2 - 15mg | Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control. | 0 | 80 | 0 | 80 |
| EG002 | Group 3 - 30mg | Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control. | 0 | 80 | 0 | 80 |
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| D006571 | Heterocyclic Compounds |