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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03137498
Other study ID # 902683
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
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