A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Mar 2014
Typical duration for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 3, 2014
CompletedFirst Posted
Study publicly available on registry
March 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
April 10, 2017
CompletedApril 10, 2017
February 1, 2017
1.8 years
March 3, 2014
January 3, 2017
February 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain Score at 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.
30 minutes
Secondary Outcomes (3)
Adverse Effect of Dizziness
120 minutes
Adverse Effect of Nausea
120 minutes
Adverse Effect of Headache
120 minutes
Study Arms (3)
Group 1 - 10 mg of Ketorolac
EXPERIMENTALSubjects will be administered 10 mg of Ketorolac for pain relief.
Group 2 - 15mg
EXPERIMENTALSubjects will be administered 15mg of Ketorolac.
Group 3 - 30mg
EXPERIMENTALSubject will receive 30mg of Ketorolac as a part of standard care.
Interventions
Patients will receive 10 mg of Ketorolac for pain control.
Patients will receive 15mg of Ketorolac for pain control.
Patients will receive 30mg of Ketorolac for pain control.
Eligibility Criteria
You may qualify if:
- Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.
You may not qualify if:
- Age \>65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Related Publications (1)
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.
PMID: 8655940BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sergey Motov
- Organization
- Maimonides Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Sergey Motov, MD
Attending
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Manager
Study Record Dates
First Submitted
March 3, 2014
First Posted
March 5, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 10, 2017
Results First Posted
April 10, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share