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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The Brooklyn Hospital Center
Brooklyn, New York, United States
RECRUITINGPain score at 15 minutes
Patient's perception of pain as described by the use of numeric rating scale (NRS) at 15 minutes after initial study interventions
Time frame: at 15 minutes after initial study interventions
Adverse event-dizziness
incidence of dizziness throughout
Time frame: throughout study period (90 minutes)
Adverse event-perioral numbness
incidence of perioral numbness
Time frame: throughout study period (90 minutes)
Adverse event-nausea
incidence of nausea
Time frame: throughout study period (90 minutes)
Adverse event-vomiting
incidence of vomiting
Time frame: throughout study period (90 minutes)
Adverse event-arrhythmia
incidence of arrhythmia (atrial fibrillation, ventricular tachycardia, ventricular fibrillation)
Time frame: throughout study period (90 minutes)
Adverse event-hypotension
incidence of hypotension (≤90/60 mmHg)
Time frame: throughout study period (90 minutes)
Adverse event-flushing
incidence of flushing
Time frame: throughout study period (90 minutes)
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Adverse event-headache
incidence of headache
Time frame: throughout study period (90 minutes)
Adverse event-tremors
incidence of tremors
Time frame: throughout study period (90 minutes)
Adverse event-ear pain
incidence of ear pain
Time frame: throughout study period (90 minutes)
Adverse event-injection site reactions
incidence of injection site reactions
Time frame: throughout study period (90 minutes)
Adverse event-disorientation
incidence of disorientation
Time frame: throughout study period (90 minutes)
Adverse event-respiratory depression
incidence of respiratory depression (respiratory rate less than 12bpm)
Time frame: throughout study period (90 minutes)
Adverse event-oxygen saturation less than 90%
incidence of oxygen saturation less than 90%
Time frame: throughout study period (90 minutes)
patient satisfaction of pain control based on a Likert Scale
based on a Likert Scale
Time frame: throughout study period (90 minutes)
the number of patients who consumed an adjuvant pain medication for analgesia.
the number of patients who consumed an adjuvant pain medication for analgesia.
Time frame: throughout study period (90 minutes)