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

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

Study Overview

• Status: Completed
• Conditions: Pain; Renal Colic
• Intervention / Treatment: Drug: Ketorolac

Detailed Description

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED). Because of the Ketorolac significant analgesic potency, it is usually used for moderate-to-severe pain. However, ketorolac has several side effects, of which gastrointestinal hemorrhage is most concerning. "Analgesic ceiling" is defined as the dose beyond which no additional analgesia can be achieved and on the other hand, more side effects might be encountered. Several studies suggested 10 mg as analgesic ceiling. Despite this, many recommendations are still advocating several folds higher doses (e.g. 30, 60 mg).

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • IKCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Severe flank and abdominal pain which pertains to renal colic according to emergency physician's gestalt

Exclusion Criteria:

• Age >65
• Active Peptic Ulcer disease
• Acute Gastrointestinal Hemorrhage
• Known History of Renal or Hepatic insufficiency
• History of allergies to NSAIDs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketorolac 10mg; Subjects will be administered 10 mg of Ketorolac.	Drug: Ketorolac; Subject will receive 10, 20, and 30mg of Ketorolac.
Experimental: Ketorolac 20mg; Subjects will be administered 20 mg of Ketorolac	Drug: Ketorolac; Subject will receive 10, 20, and 30mg of Ketorolac.
Experimental: Ketorolac 30mg; As a part of standard care, subjects will be administered 30 mg of Ketorolac.	Drug: Ketorolac; Subject will receive 10, 20, and 30mg of Ketorolac.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 Minutes
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.	45 Minutes
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.	60 Minutes
Adverse Effects	Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)	60 Minutes

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): September 9, 2019
• Study Completion (Actual): November 9, 2019

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 4, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Renal Colic; Colic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: 9521307004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No