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

Primary Purpose

Renal Colic

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lidocaine

Ketorolac

About this trial

This is an interventional treatment trial for Renal Colic focused on measuring renal colic, lidocaine, ketorolac, acute pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

The Brooklyn Hospital CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lidocaine

Ketorolac

Arm Description

Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes (active experimental) and normal saline 1ml intravenous push injection (placebo)

Ketorolac 30mg (1ml) intravenous push injection (active intervention) and Normal saline 50ml IVPB over 10 minutes (placebo)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse event-dizziness

incidence of dizziness throughout

Adverse event-perioral numbness

incidence of perioral numbness

Adverse event-nausea

incidence of nausea

Adverse event-vomiting

incidence of vomiting

Adverse event-arrhythmia

incidence of arrhythmia (atrial fibrillation, ventricular tachycardia, ventricular fibrillation)

Adverse event-hypotension

incidence of hypotension (≤90/60 mmHg)

Adverse event-flushing

incidence of flushing

Adverse event-headache

incidence of headache

Adverse event-tremors

incidence of tremors

Adverse event-ear pain

incidence of ear pain

Adverse event-injection site reactions

incidence of injection site reactions

Adverse event-disorientation

incidence of disorientation

Adverse event-respiratory depression

incidence of respiratory depression (respiratory rate less than 12bpm)

Adverse event-oxygen saturation less than 90%

incidence of oxygen saturation less than 90%

patient satisfaction of pain control based on a Likert Scale

based on a Likert Scale

the number of patients who consumed an adjuvant pain medication for analgesia.

Full Information

NCT ID

NCT03137498

First Posted

March 6, 2017

Last Updated

July 9, 2018

Sponsor

The Brooklyn Hospital Center

1. Study Identification

Unique Protocol Identification Number

NCT03137498

Brief Title

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

Official Title

Lidocaine Versus Ketorolac for the Management of Renal Colic

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 6, 2017 (Actual)

Primary Completion Date

March 6, 2019 (Anticipated)

Study Completion Date

March 6, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Brooklyn Hospital Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Colic

Keywords

renal colic, lidocaine, ketorolac, acute pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Experimental

Arm Description

Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes (active experimental) and normal saline 1ml intravenous push injection (placebo)

Arm Title

Ketorolac

Arm Type

Active Comparator

Arm Description

Ketorolac 30mg (1ml) intravenous push injection (active intervention) and Normal saline 50ml IVPB over 10 minutes (placebo)

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Other Intervention Name(s)

Prilocaine

Intervention Description

Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes x 1dose

Intervention Type

Drug

Intervention Name(s)

Ketorolac

Other Intervention Name(s)

Toradol

Intervention Description

Ketorolac 30mg (1ml) intravenous push injection x 1dose

Primary Outcome Measure Information:

Title

Pain score at 15 minutes

Description

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

Secondary Outcome Measure Information:

Title

Adverse event-dizziness

Description

incidence of dizziness throughout

Time Frame