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

Renal Colic Clinical Trial

Official title:

Lidocaine Versus Ketorolac for the Management of Renal Colic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03137498
• Other study ID #: 902683
• Status: Recruiting
• Phase: Phase 4
• Start date: March 6, 2017
• Est. completion date: March 6, 2019

Study information

• Verified date: July 2018
• Source: The Brooklyn Hospital Center
• Contact: Billy Sin, PharmD
• Phone: 718-250-6250
• Email: bsin[@]tbh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 6, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

Drug:
• Lidocaine
Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes x 1dose
• Ketorolac
Ketorolac 30mg (1ml) intravenous push injection x 1dose

Locations

Country	Name	City	State
United States	The Brooklyn Hospital Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Brooklyn Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse event-dizziness	incidence of dizziness throughout	throughout study period (90 minutes)
Secondary	Adverse event-perioral numbness	incidence of perioral numbness	throughout study period (90 minutes)
Secondary	Adverse event-nausea	incidence of nausea	throughout study period (90 minutes)
Secondary	Adverse event-vomiting	incidence of vomiting	throughout study period (90 minutes)
Secondary	Adverse event-arrhythmia	incidence of arrhythmia (atrial fibrillation, ventricular tachycardia, ventricular fibrillation)	throughout study period (90 minutes)
Secondary	Adverse event-hypotension	incidence of hypotension (=90/60 mmHg)	throughout study period (90 minutes)
Secondary	Adverse event-flushing	incidence of flushing	throughout study period (90 minutes)
Secondary	Adverse event-headache	incidence of headache	throughout study period (90 minutes)
Secondary	Adverse event-tremors	incidence of tremors	throughout study period (90 minutes)
Secondary	Adverse event-ear pain	incidence of ear pain	throughout study period (90 minutes)
Secondary	Adverse event-injection site reactions	incidence of injection site reactions	throughout study period (90 minutes)
Secondary	Adverse event-disorientation	incidence of disorientation	throughout study period (90 minutes)
Secondary	Adverse event-respiratory depression	incidence of respiratory depression (respiratory rate less than 12bpm)	throughout study period (90 minutes)
Secondary	Adverse event-oxygen saturation less than 90%	incidence of oxygen saturation less than 90%	throughout study period (90 minutes)
Secondary	patient satisfaction of pain control based on a Likert Scale	based on a Likert Scale	throughout study period (90 minutes)
Secondary	the number of patients who consumed an adjuvant pain medication for analgesia.	the number of patients who consumed an adjuvant pain medication for analgesia.	throughout study period (90 minutes)