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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02078492
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Tracking Information
First Submitted Date  ICMJE March 3, 2014
First Posted Date  ICMJE March 5, 2014
Results First Submitted Date  ICMJE January 3, 2017
Results First Posted Date  ICMJE April 10, 2017
Last Update Posted Date April 10, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2014)
The difference between 3 groups in pain relief at 30 minutes. [ Time Frame: 1 year ]
The difference between 3 groups in pain relief at 30 minutes.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2017)
  • Adverse Effect of Dizziness [ Time Frame: 120 minutes ]
    the number of study patients who reported having dizziness after administration of medication.
  • Adverse Effect of Nausea [ Time Frame: 120 minutes ]
    The number of study patients who reported nausea after administration of medication
  • Adverse Effect of Headache [ Time Frame: 120 minutes ]
    The number of study patients who reported headache after administration of medication
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2014)
The rate of side effects related to administration of Ketorolac [ Time Frame: 1 year ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management
Official Title  ICMJE A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management in the Emergency Department"
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: 10 mg of Ketorolac
    Patients will receive 10 mg of Ketorolac for pain control.
    Other Name: Toradol
  • Drug: 15 mg of Ketorolac
    Patients will receive 15mg of Ketorolac for pain control.
    Other Name: Toradol
  • Drug: 30 mg of Ketorolac
    Patients will receive 30mg of Ketorolac for pain control.
    Other Name: Toradol
Study Arms  ICMJE
  • Experimental: Group 1 - 10 mg of Ketorolac
    Subjects will be administered 10 mg of Ketorolac for pain relief.
    Intervention: Drug: 10 mg of Ketorolac
  • Experimental: Group 2 - 15mg
    Subjects will be administered 15mg of Ketorolac.
    Intervention: Drug: 15 mg of Ketorolac
  • Experimental: Group 3 - 30mg
    Subject will receive 30mg of Ketorolac as a part of standard care.
    Intervention: Drug: 30 mg of Ketorolac
Publications * Catapano MS. The analgesic efficacy of ketorolac for acute pain. J Emerg Med. 1996 Jan-Feb;14(1):67-75. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2014)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02078492
Other Study ID Numbers  ICMJE 2014-01-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Antonios Likourezos, Maimonides Medical Center
Study Sponsor  ICMJE Antonios Likourezos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sergey Motov, MD Attending
PRS Account Maimonides Medical Center
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP