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

Phase 4

Completed

Interventions: Drug: 30 mg of Ketorolac
Drug: 15 mg of Ketorolac
Drug: 10 mg of Ketorolac

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Group 3 - 30mg	30 mg of Ketorolac	Subject will receive 30mg of Ketorolac as a part of standard care.
Group 2 - 15mg	15 mg of Ketorolac	Subjects will be administered 15mg of Ketorolac.
Group 1 - 10 mg of Ketorolac	10 mg of Ketorolac	Subjects will be administered 10 mg of Ketorolac for pain relief.

Primary Outcome Measures

Name	Time	Method
Pain Score at 30 Minutes	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Effect of Nausea	120 minutes	The number of study patients who reported nausea after administration of medication
Adverse Effect of Dizziness	120 minutes	the number of study patients who reported having dizziness after administration of medication.
Adverse Effect of Headache	120 minutes	The number of study patients who reported headache after administration of medication