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

NCT ID: NCT03137498

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-06
• Study Completion Date: 2019-03-06

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).

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.

Conditions

Renal Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine

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

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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

Ketorolac

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

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

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

Interventions

Lidocaine

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

Intervention Type: DRUG

Ketorolac

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

Intervention Type: DRUG

Other Intervention Names

Prilocaine; Toradol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Brooklyn Hospital Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie de Souza, MD

Role: STUDY_CHAIR

The Brooklyn Hospital Center

Locations

The Brooklyn Hospital Center

Brooklyn, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Billy Sin, PharmD

Role: CONTACT

bsin@tbh.org

718-250-6250

Facility Contacts

Billy W Sin, Pharm.D.

Role: primary

718-250-6250

Michael Hochberg, MD

Role: backup

718-250-6202

Other Identifiers

902683

Identifier Type: -

Identifier Source: org_study_id