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

NCT ID: NCT02078492

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-12-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1 - 10 mg of Ketorolac

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

Group Type: EXPERIMENTAL

10 mg of Ketorolac

Intervention Type: DRUG

Patients will receive 10 mg of Ketorolac for pain control.

Group 2 - 15mg

Subjects will be administered 15mg of Ketorolac.

Group Type: EXPERIMENTAL

15 mg of Ketorolac

Intervention Type: DRUG

Patients will receive 15mg of Ketorolac for pain control.

Group 3 - 30mg

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

Group Type: EXPERIMENTAL

30 mg of Ketorolac

Intervention Type: DRUG

Patients will receive 30mg of Ketorolac for pain control.

Interventions

10 mg of Ketorolac

Patients will receive 10 mg of Ketorolac for pain control.

Intervention Type: DRUG

15 mg of Ketorolac

Patients will receive 15mg of Ketorolac for pain control.

Intervention Type: DRUG

30 mg of Ketorolac

Patients will receive 30mg of Ketorolac for pain control.

Intervention Type: DRUG

Other Intervention Names

Toradol; Toradol; Toradol

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Antonios Likourezos

OTHER

Sponsor Role: lead

Responsible Party

Antonios Likourezos

Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sergey Motov, MD

Role: PRINCIPAL_INVESTIGATOR

Attending

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 8655940 (View on PubMed)

Other Identifiers

2014-01-19

Identifier Type: -

Identifier Source: org_study_id