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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Lidocaine Versus Ketorolac for the Management of Renal Colic

Conditions
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Renal Colic

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes (active experimental) and normal saline 1ml intravenous push injection (placebo) | Drug: Lidocaine<br>* Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes x 1dose<br>* Other names: Prilocaine;|
| Active Comparator: Ketorolac<br>Ketorolac 30mg (1ml) intravenous push injection (active intervention) and Normal saline 50ml IVPB over 10 minutes (placebo) | Drug: Ketorolac<br>* Ketorolac 30mg (1ml) intravenous push injection x 1dose<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 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 | at 15 minutes after initial study interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event-dizziness | incidence of dizziness throughout | throughout study period (90 minutes) | 
| Adverse event-perioral numbness | incidence of perioral numbness | throughout study period (90 minutes) | 
| Adverse event-nausea | incidence of nausea | throughout study period (90 minutes) | 
| Adverse event-vomiting | incidence of vomiting | throughout study period (90 minutes) | 
| Adverse event-arrhythmia | incidence of arrhythmia (atrial fibrillation, ventricular tachycardia, ventricular fibrillation) | throughout study period (90 minutes) | 
| Adverse event-hypotension | incidence of hypotension (≤90/60 mmHg) | throughout study period (90 minutes) | 
| Adverse event-flushing | incidence of flushing | throughout study period (90 minutes) | 
| Adverse event-headache | incidence of headache | throughout study period (90 minutes) | 
| Adverse event-tremors | incidence of tremors | throughout study period (90 minutes) | 
| Adverse event-ear pain | incidence of ear pain | throughout study period (90 minutes) | 
| Adverse event-injection site reactions | incidence of injection site reactions | throughout study period (90 minutes) | 
| Adverse event-disorientation | incidence of disorientation | throughout study period (90 minutes) | 
| Adverse event-respiratory depression | incidence of respiratory depression (respiratory rate less than 12bpm) | throughout study period (90 minutes) | 
| Adverse event-oxygen saturation less than 90% | incidence of oxygen saturation less than 90% | throughout study period (90 minutes) | 
| patient satisfaction of pain control based on a Likert Scale | based on a Likert Scale | 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. | throughout study period (90 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal colic, lidocaine, ketorolac, acute pain