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

Antonios Likourezos

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: 30 mg of Ketorolac; Drug: 10 mg of Ketorolac; Drug: 15 mg of Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT02078492

2014-01-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups

Group 1 - 10 mg of Ketorolac

Experimental group

Description:

Subjects will be administered 10 mg of Ketorolac for pain relief.

Treatment:

Drug: 10 mg of Ketorolac

Group 2 - 15mg

Experimental group

Description:

Subjects will be administered 15mg of Ketorolac.

Treatment:

Drug: 15 mg of Ketorolac

Group 3 - 30mg

Experimental group

Description:

Subject will receive 30mg of Ketorolac as a part of standard care.

Treatment:

Drug: 30 mg of Ketorolac