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

July 9, 2018 updated by: The Brooklyn Hospital Center

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Billy Sin, PharmD
  • Phone Number: 718-250-6250
  • Email: bsin@tbh.org

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at 15 minutes after initial study interventions

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse event-dizziness
Time Frame: throughout study period (90 minutes)
incidence of dizziness throughout
throughout study period (90 minutes)
Adverse event-perioral numbness
Time Frame: throughout study period (90 minutes)
incidence of perioral numbness
throughout study period (90 minutes)
Adverse event-nausea
Time Frame: throughout study period (90 minutes)
incidence of nausea
throughout study period (90 minutes)
Adverse event-vomiting
Time Frame: throughout study period (90 minutes)
incidence of vomiting
throughout study period (90 minutes)
Adverse event-arrhythmia
Time Frame: throughout study period (90 minutes)
incidence of arrhythmia (atrial fibrillation, ventricular tachycardia, ventricular fibrillation)
throughout study period (90 minutes)
Adverse event-hypotension
Time Frame: throughout study period (90 minutes)
incidence of hypotension (≤90/60 mmHg)
throughout study period (90 minutes)
Adverse event-flushing
Time Frame: throughout study period (90 minutes)
incidence of flushing
throughout study period (90 minutes)
Adverse event-headache
Time Frame: throughout study period (90 minutes)
incidence of headache
throughout study period (90 minutes)
Adverse event-tremors
Time Frame: throughout study period (90 minutes)
incidence of tremors
throughout study period (90 minutes)
Adverse event-ear pain
Time Frame: throughout study period (90 minutes)
incidence of ear pain
throughout study period (90 minutes)
Adverse event-injection site reactions
Time Frame: throughout study period (90 minutes)
incidence of injection site reactions
throughout study period (90 minutes)
Adverse event-disorientation
Time Frame: throughout study period (90 minutes)
incidence of disorientation
throughout study period (90 minutes)
Adverse event-respiratory depression
Time Frame: throughout study period (90 minutes)
incidence of respiratory depression (respiratory rate less than 12bpm)
throughout study period (90 minutes)
Adverse event-oxygen saturation less than 90%
Time Frame: throughout study period (90 minutes)
incidence of oxygen saturation less than 90%
throughout study period (90 minutes)
patient satisfaction of pain control based on a Likert Scale
Time Frame: throughout study period (90 minutes)
based on a Likert Scale
throughout study period (90 minutes)
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.
throughout study period (90 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Brooklyn Hospital Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Sylvie de Souza, MD, The Brooklyn Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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