Lidocaine vs Ketorolac for Management of Renal Colic in the Emergency Department

Last updated: July 9, 2018
Sponsor: The Brooklyn Hospital Center
Overall Status: Active - Recruiting

Phase

4

Condition

Colic

Acute Pain

Kidney Stones

Treatment

N/A

Clinical Study ID

NCT03137498
902683
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The hypothesis of the study is that lidocaine will be as effective as ketorolac in decreasing patient's perception of pain as measured by the 10 point Visual Analogue Scale (VAS). The aim of the study is to compare the safety & efficacy of lidocaine versus ketorolac for acute pain secondary to renal colic in the Emergency Department (ED).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years old and older

  • Presenting with acute generalized pain secondary to suspected or confirmed renal colic

  • Describes pain to be greater than or equal to 3 out of 10 on the numeric rating scale (NRS)

  • Provides informed consent.

Exclusion

Exclusion Criteria:

  • Reported/documented allergy to lidocaine OR ketorolac (Toradol) OR morphine, corn,aspirin, ibuprofen

  • Patients who are hemodynamically unstable as dictated by the medical resident orattending [(Heart rate not within 60-110bpm); (Respiratory rate not within 12-20 bpm); (Blood pressure not within 90/50 to 180/100); (Oxygen saturation not within 94-100%)]

  • Patient with unwillingness to provide informed consent

  • Patients with past medical history of cardiovascular disorders (examples include butare not limited to: myocardial infarction, ischemic heart disease, atrialfibrillation, heart blocks, Wolff-Parkinson-White syndrome, slow heart rate,bradycardia, coronary artery disease, QT prolongation)

  • Past medical history of: liver dysfunction (ie: cirrhosis), chronic alcohol abuse,gastrointestinal bleed or recent gastrointestinal bleed (within past 5 days), renaldysfunction or disease, seizures (or currently actively receiving treatment forseizures), inflammatory bowel disease (or currently actively receiving treatment forinflammatory bowel disease), hepatitis (or currently actively receiving treatment forhepatitis).

  • History of liver transplant

  • Currently on dialysis

  • Has acute heart, kidney, liver, respiratory failure or trauma

  • In altered mental status

  • In significant trauma, actively breastfeeding or pregnant

  • Has language barriers who are unable to describe pain,

  • Weighing at or over 130kg

  • Has a blood pressure reading greater than 180/120 mmHg at triage,

  • Previously enrolled to the study

Study Design

Total Participants: 60
Study Start date:
March 06, 2017
Estimated Completion Date:
March 06, 2019

Study Description

The hypothesis of the study is that lidocaine will be as effective as ketorolac in decreasing patient's perception of pain as measured by the 10 point Visual Analogue Scale (VAS). The aim of the study is to compare the safety & efficacy of lidocaine versus ketorolac for acute pain secondary to renal colic in the Emergency Department (ED). The primary endpoint is patient's perception of pain as described by the use of numeric rating scale (NRS) at 15 minutes after initial study interventions. The secondary endpoints are incidence of adverse events during the study period, patient perception of pain as described by the use of NRS at 0, 5, 15, 30, 45, 60, 75, 90 minutes after initial administration of study interventions, frequency and mean dose of rescue analgesic therapy needed at 0, 5, 15, 30, 45, 60, 75, 90 minutes, incidence of adverse events such as but would not be limited to: dizziness, perioral numbness, nausea, vomiting, arrhythmia [examples could be but are not limited to: atrial fibrillation, ventricular tachycardia, ventricular fibrillation), hypotension (≤90/60 mmHg), flushing, headache, tremors, ear pain, injection site reactions, disorientation, respiratory depression (respiratory rate less than 12bpm), oxygen saturation less than 90%)], the number of bedside ultrasounds for diagnosis conducted, the number of CT scans for diagnosis conducted, result of radiologic imaging (Ultrasound / Computerized Tomography), time to patient discharge from the initiation of study medication/placebo, patient satisfaction of pain control based on a Likert Scale, the number of patients who consumed an adjuvant pain medication for analgesia.

Connect with a study center

  • The Brooklyn Hospital Center

    Brooklyn, New York 11201
    United States

    Active - Recruiting

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