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

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).

Study Overview

• Status: Unknown
• Conditions: Renal Colic
• Intervention / Treatment: Drug: Lidocaine; Drug: Ketorolac

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11201
      • Recruiting
      • The Brooklyn Hospital Center
      • Contact: Billy W Sin, Pharm.D.; Phone Number: 718-250-6250
      • Contact: Michael Hochberg, MD; Phone Number: 718-250-6202

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The Brooklyn Hospital Center
• Investigators: Study Chair: Sylvie de Souza, MD, The Brooklyn Hospital Center

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Anticipated): March 6, 2019
• Study Completion (Anticipated): March 6, 2019

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: lidocaine; acute pain; ketorolac; renal colic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Renal Colic; Colic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ketorolac; Prilocaine
• Other Study ID Numbers: 902683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No