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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:7/13/2018
Start Date:March 6, 2017
End Date:March 6, 2019
Contact:Billy Sin, PharmD
Email:bsin@tbh.org
Phone:718-250-6250

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Lidocaine Versus Ketorolac for the Management of Renal Colic

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 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.

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 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 or
attending [(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 but
are not limited to: myocardial infarction, ischemic heart disease, atrial
fibrillation, 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), renal
dysfunction or disease, seizures (or currently actively receiving treatment for
seizures), inflammatory bowel disease (or currently actively receiving treatment for
inflammatory bowel disease), hepatitis (or currently actively receiving treatment for
hepatitis).

- 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
We found this trial at
1
site
121 Dekalb Ave
Brooklyn, New York 11205
(718) 250-8000
Phone: 718-250-6250
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