NCT03137498

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

Lidocaine Versus Ketorolac for the Management of Renal Colic

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Brooklyn Hospital Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Lidocaine	Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes x 1dose
DRUG	Ketorolac	Ketorolac 30mg (1ml) intravenous push injection x 1dose

Timeline

• Start date: 2017-03-06
• Primary completion: 2019-03-06
• Completion: 2019-03-06
• First posted: 2017-05-02
• Last updated: 2018-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study