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

Early Phase 1CompletedNCT03665753

Tehran University of Medical Sciences165 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

165

Conditions

Pain Renal Colic

Interventions

KetorolacDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

IKCH

Tehran, Iran

Outcomes

Primary Outcomes

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.

Time frame: 30 Minutes

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 60 Minutes

Adverse Effects

Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)

Time frame: 60 Minutes

Data from ClinicalTrials.gov

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