Clinical Trial: Lidocaine vs Ketorolac for Renal Colic

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Lidocaine Versus Ketorolac for the Management of Renal Colic

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 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). 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.
Sponsor: The Brooklyn Hospital Center

Current Primary Outcome: Pain score at 15 minutes [ Time Frame: at 15 minutes after initial study interventions ]

Patient's perception of pain as described by the use of numeric rating scale (NRS) at 15 minutes after initial study interventions


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: The Brooklyn Hospital Center

Dates:
Date Received: March 6, 2017
Date Started: March 6, 2017
Date Completion: March 6, 2019
Last Updated: April 28, 2017
Last Verified: March 2017