Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED

Early Phase 1

Completed

• Conditions: Pain; Renal Colic
• Interventions: Drug: Ketorolac

• Registration Number: NCT03665753
• Lead Sponsor: Tehran University of Medical Sciences

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

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 Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-11
• Study Start: 2018-11-05
• Primary Completion: 2019-09-09
• Study Completion: 2019-11-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-04
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Ketorolac 30mg	Ketorolac	As a part of standard care, subjects will be administered 30 mg of Ketorolac.
Ketorolac 10mg	Ketorolac	Subjects will be administered 10 mg of Ketorolac.
Ketorolac 20mg	Ketorolac	Subjects will be administered 20 mg of Ketorolac

Primary Outcome Measures

Name	Time	Method
Pain assessed with visual analogue scale (VAS)	30 Minutes	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Effects	60 Minutes	Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)
Pain assessed with visual analogue scale (VAS)	60 Minutes	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.

Trial Locations

Locations (1)

IKCH; 🇮🇷 Tehran, Iran, Islamic Republic of