Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED
Comparison of Intravenous Ketorolac 10, 20, and 30mg for Treating Renal Colic Pain in the Emergency Department: A Randomized Controlled Trial
1 other identifier
interventional
165
1 country
1
Brief Summary
Hypothesis: Intravenous administration of Ketorolac 10 mg and 20 mg is as effective as 30 mg in treating renal colic pain in patients presenting to the emergency department
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 pain
Started Nov 2018
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
First Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 11, 2018
CompletedStudy Start
First participant enrolled
November 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2019
CompletedJuly 7, 2020
July 1, 2020
10 months
September 5, 2018
July 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Pain assessed with visual analogue scale (VAS)
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
30 Minutes
Secondary Outcomes (4)
Pain assessed with visual analogue scale (VAS)
15 Minutes
Pain assessed with visual analogue scale (VAS)
45 Minutes
Pain assessed with visual analogue scale (VAS)
60 Minutes
Adverse Effects
60 Minutes
Study Arms (3)
Ketorolac 10mg
EXPERIMENTALSubjects will be administered 10 mg of Ketorolac.
Ketorolac 20mg
EXPERIMENTALSubjects will be administered 20 mg of Ketorolac
Ketorolac 30mg
EXPERIMENTALAs a part of standard care, subjects will be administered 30 mg of Ketorolac.
Interventions
Subject will receive 10, 20, and 30mg of Ketorolac.
Eligibility Criteria
You may qualify if:
- Severe flank and abdominal pain which pertains to renal colic according to emergency physician's gestalt
You may not qualify if:
- Age \>65
- Active Peptic Ulcer disease
- Acute Gastrointestinal Hemorrhage
- Known History of Renal or Hepatic insufficiency
- History of allergies to NSAIDs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IKCH
Tehran, Iran
Related Publications (1)
Eidinejad L, Bahreini M, Ahmadi A, Yazdchi M, Thiruganasambandamoorthy V, Mirfazaelian H. Comparison of intravenous ketorolac at three doses for treating renal colic in the emergency department: A noninferiority randomized controlled trial. Acad Emerg Med. 2021 Jul;28(7):768-775. doi: 10.1111/acem.14202. Epub 2021 Feb 17.
PMID: 33370510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Emergency Medicine
Study Record Dates
First Submitted
September 5, 2018
First Posted
September 11, 2018
Study Start
November 5, 2018
Primary Completion
September 9, 2019
Study Completion
November 9, 2019
Last Updated
July 7, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share