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

Tehran University of Medical Sciences

Status and phase: Completed; Early Phase 1

Conditions: Pain; Renal Colic

Treatments: Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT03665753

9521307004

Details and patient eligibility

About

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

Full 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).

Enrollment: 165 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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165 participants in 3 patient groups

Ketorolac 10mg

Experimental group

Description:

Subjects will be administered 10 mg of Ketorolac.

Treatment:

Drug: Ketorolac

Ketorolac 20mg

Experimental group

Description:

Subjects will be administered 20 mg of Ketorolac

Treatment:

Drug: Ketorolac

Ketorolac 30mg

Experimental group

Description:

As a part of standard care, subjects will be administered 30 mg of Ketorolac.

Treatment:

Drug: Ketorolac