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

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ClinicalTrials.gov Identifier: NCT03137498
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
The Brooklyn Hospital Center

Brief 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).

Condition or disease Intervention/treatment Phase
Renal Colic Drug: Lidocaine Drug: Ketorolac Phase 4

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind placebo-controlled randomized trial where blinding will be conducted and applied to the study investigator, physicians, and nursing staff providing care to the patient. An independent biostatistician will conduct a statistical analysis with blinded data. Only the pharmacists preparing the study interventions will be unblended to the study treatments. The pharmacists procuring the interventions will not be part of data collection or analysis.
Primary Purpose: Treatment
Official Title: Lidocaine Versus Ketorolac for the Management of Renal Colic
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : March 6, 2019
Estimated Study Completion Date : March 6, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Toradol




Primary Outcome Measures :
  1. Pain score at 15 minutes [ Time Frame: at 15 minutes after initial study interventions ]
    Patient's perception of pain as described by the use of numeric rating scale (NRS) at 15 minutes after initial study interventions


Secondary Outcome Measures :
  1. Adverse event-dizziness [ Time Frame: throughout study period (90 minutes) ]
    incidence of dizziness throughout

  2. Adverse event-perioral numbness [ Time Frame: throughout study period (90 minutes) ]
    incidence of perioral numbness

  3. Adverse event-nausea [ Time Frame: throughout study period (90 minutes) ]
    incidence of nausea

  4. Adverse event-vomiting [ Time Frame: throughout study period (90 minutes) ]
    incidence of vomiting

  5. Adverse event-arrhythmia [ Time Frame: throughout study period (90 minutes) ]
    incidence of arrhythmia (atrial fibrillation, ventricular tachycardia, ventricular fibrillation)

  6. Adverse event-hypotension [ Time Frame: throughout study period (90 minutes) ]
    incidence of hypotension (≤90/60 mmHg)

  7. Adverse event-flushing [ Time Frame: throughout study period (90 minutes) ]
    incidence of flushing

  8. Adverse event-headache [ Time Frame: throughout study period (90 minutes) ]
    incidence of headache

  9. Adverse event-tremors [ Time Frame: throughout study period (90 minutes) ]
    incidence of tremors

  10. Adverse event-ear pain [ Time Frame: throughout study period (90 minutes) ]
    incidence of ear pain

  11. Adverse event-injection site reactions [ Time Frame: throughout study period (90 minutes) ]
    incidence of injection site reactions

  12. Adverse event-disorientation [ Time Frame: throughout study period (90 minutes) ]
    incidence of disorientation

  13. Adverse event-respiratory depression [ Time Frame: throughout study period (90 minutes) ]
    incidence of respiratory depression (respiratory rate less than 12bpm)

  14. Adverse event-oxygen saturation less than 90% [ Time Frame: throughout study period (90 minutes) ]
    incidence of oxygen saturation less than 90%

  15. patient satisfaction of pain control based on a Likert Scale [ Time Frame: throughout study period (90 minutes) ]
    based on a Likert Scale

  16. the number of patients who consumed an adjuvant pain medication for analgesia. [ Time Frame: throughout study period (90 minutes) ]
    the number of patients who consumed an adjuvant pain medication for analgesia.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137498


Contacts
Contact: Billy Sin, PharmD 718-250-6250 bsin@tbh.org

Locations
United States, New York
The Brooklyn Hospital Center Recruiting
Brooklyn, New York, United States, 11201
Contact: Billy W Sin, Pharm.D.    718-250-6250      
Contact: Michael Hochberg, MD    718-250-6202      
Sponsors and Collaborators
The Brooklyn Hospital Center
Investigators
Study Chair: Sylvie de Souza, MD The Brooklyn Hospital Center

Responsible Party: The Brooklyn Hospital Center
ClinicalTrials.gov Identifier: NCT03137498     History of Changes
Other Study ID Numbers: 902683
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by The Brooklyn Hospital Center:
renal colic
lidocaine
ketorolac
acute pain

Additional relevant MeSH terms:
Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Ketorolac
Ketorolac Tromethamine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors