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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2019-11-09

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Pain Renal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Dose escalation study.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketorolac 10mg

Subjects will be administered 10 mg of Ketorolac.

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

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

Ketorolac 20mg

Subjects will be administered 20 mg of Ketorolac

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

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

Ketorolac 30mg

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

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

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

Interventions

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Ketorolac

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes