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Completed

NCT Number: NCT02078492

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

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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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10 mg of Ketorolac

Drug

Patients will receive 10 mg of Ketorolac for pain control.

Other names: Toradol

15 mg of Ketorolac

Drug

Patients will receive 15mg of Ketorolac for pain control.

Other names: Toradol

30 mg of Ketorolac

Drug

Patients will receive 30mg of Ketorolac for pain control.

Other names: Toradol

Primary outcomes

  1. Pain Score at 30 Minutes

    Time frame: 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 outcomes

  1. Adverse Effect of Dizziness

    Time frame: 120 minutes

    the number of study patients who reported having dizziness after administration of medication.

  2. Adverse Effect of Nausea

    Time frame: 120 minutes

    The number of study patients who reported nausea after administration of medication

  3. Adverse Effect of Headache

    Time frame: 120 minutes

    The number of study patients who reported headache after administration of medication

Sponsors and collaborators

Lead sponsor

Antonios Likourezos

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2014
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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