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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078492
• Other study ID #: 2014-01-19
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2014
• Last updated: September 5, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 10 mg of Ketorolac
Patients will receive 10 mg of Ketorolac for pain control.
• 15 mg of Ketorolac
Patients will receive 15mg of Ketorolac for pain control.
• 30 mg of Ketorolac
Patients will receive 30mg of Ketorolac for pain control.

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Antonios Likourezos

Country where clinical trial is conducted

United States, 

References & Publications (1)

Catapano MS. The analgesic efficacy of ketorolac for acute pain. J Emerg Med. 1996 Jan-Feb;14(1):67-75. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between 3 groups in pain relief at 30 minutes.	The difference between 3 groups in pain relief at 30 minutes.	1 year	Yes
Secondary	The rate of side effects related to administration of Ketorolac	The rate of side effects related to administration of Ketorolac that will include: acute gastrointestinal hemorrhage (required re-admission, EGD, colonoscopy or PRBC transfusion; new onset CHF; worsening of pre-existing CHF, new onset of renal or hepatic failure, severe allergic reactions.	1 year	Yes