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

NCT03137498 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 902683
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Colic

Keywords

renal colic; lidocaine; ketorolac; acute pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Adverse event-dizziness

  throughout study period (90 minutes)

• Adverse event-perioral numbness

  throughout study period (90 minutes)

• Adverse event-nausea

  throughout study period (90 minutes)

• Adverse event-vomiting

  throughout study period (90 minutes)

• Adverse event-arrhythmia

  throughout study period (90 minutes)

Study Arms (2)

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

Ketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac

Interventions

Lidocaine DRUG

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

Also known as: Prilocaine

Lidocaine

Ketorolac DRUG

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

Also known as: Toradol

Ketorolac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Brooklyn Hospital Center: lead

Study Sites (1)

The Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

RECRUITING

MeSH Terms

Conditions

Renal Colic; Acute Pain

Interventions

Lidocaine; Prilocaine; Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sylvie de Souza, MD

  The Brooklyn Hospital Center

  STUDY CHAIR

Central Study Contacts

Billy Sin, PharmD

CONTACT

718-250-6250; bsin@tbh.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: May 2, 2017
• Study Start: March 6, 2017
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)