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

Pain Clinical Trial

Official title:

Comparison of Intravenous Ketorolac 10, 20, and 30mg for Treating Renal Colic Pain in the Emergency Department: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665753
• Other study ID #: 9521307004
• Status: Completed
• Phase: Early Phase 1
• Start date: November 5, 2018
• Est. completion date: November 9, 2019

Study information

• Verified date: July 2020
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Pain
• Renal Colic

Intervention

Drug:
• Ketorolac
Subject will receive 10, 20, and 30mg of Ketorolac.

Locations

Country	Name	City	State
Iran, Islamic Republic of	IKCH	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Adverse Effects	Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)	60 Minutes