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Intravenous Lidocaine and Ketorolac for Pain Management

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ClinicalTrials.gov Identifier: NCT02902770
Recruitment Status : Active, not recruiting
First Posted : September 16, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Brief Summary:
The literature regarding analgesic modalities, their combinations and routes of administrations for patients with pain related to renal colic is expanding. NSAID's (IV ketorolac) and opioids (morphine) constitutes the mainstay of treatment of renal colic either alone or in combinations. Despite their synergism and analgesic superiority when administered together, both classes of these medications possess a set of unfavorable side effects that limit their use. Emerging data of the use of IV lidocaine for patients with renal colic demonstrated good analgesic efficacy and safety profile. However, none of the trials directly compared lidocaine to ketorolac or the combination of both as viable options in patients unable to tolerate or to have serious contraindications to opioids. We designed a double-blinded, randomized, controlled trial to evaluate analgesic efficacy, safety and feasibility of non-opioid analgesics and their combinations in patients with renal colic. The hypothesis and proposed study will try to determine if a combination of IV lidocaine and reduced dose of IV ketorolac is superior to either drug alone and if this non-opioid analgesic modality is effective for controlling pain of renal colic origin.

Condition or disease Intervention/treatment Phase
Pain Drug: Lidocaine Drug: Ketorolac Tromethamine Drug: Normal Saline Drip Drug: Normal Saline Push Phase 4

Detailed Description:

The investigators designed a double-blind, randomized, clinical trial to evaluate analgesic efficacy, safety and feasibility of non-opioid analgesics IV Lidocaine and IV Ketorolac and combination of both in patients with renal colic. The hypothesis and proposed study will try to determine if a combination of IV lidocaine and IV ketorolac is superior to either drug alone and if this non-opioid analgesic combination is effective for controlling pain of renal colic origin. The trial will compare pain scores at 15 min and 30 min between and within the three treatment groups of the study: IV ketorolac 30mg push and 10 minute normal saline drip placebo, 1.5mg/kg IV lidocaine drip (given over 10 minutes) and normal saline push placebo, or IV ketorolac push and IV lidocaine drip.

Once a patient is enrolled, the on duty ED pharmacist will prepare any one of the three treatment groups based on a predetermined randomization list generated via SPSS 19.0.The study investigators will record pain scores, vital signs, and side effects at baseline, 15, 30 and 60 minutes post-medication administration. If the patient still reports pain of five or greater and requests additional pain relief then morphine at 0.1mg/kg will be given as the rescue analgesic. Blinding of medication from the patient, research team, and staff will be strictly maintained by the pharmacist investigators.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing the Combination of Intravenous Lidocaine and Ketorolac to Either Analgesics Alone for ED Patients With Acute Renal Colic
Study Start Date : October 2016
Actual Primary Completion Date : October 4, 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine and normal saline push
1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push
Drug: Lidocaine
1.5 mg/kg IV lidocaine drip (given over 10 minutes)
Other Name: Xylocaine

Drug: Normal Saline Push
Normal Saline Push Placebo
Other Name: Normal Saline

Active Comparator: Ketorolac and normal saline drip
IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip
Drug: Ketorolac Tromethamine
IV ketorolac 30mg push
Other Name: Toradol

Drug: Normal Saline Drip
Normal Saline Drip Placebo given over 10 minutes
Other Name: Normal Saline

Active Comparator: Lidocaine and Ketorolac
IV Lidocaine Drip and IV Ketorolac Push
Drug: Lidocaine
1.5 mg/kg IV lidocaine drip (given over 10 minutes)
Other Name: Xylocaine

Drug: Ketorolac Tromethamine
IV ketorolac 30mg push
Other Name: Toradol




Primary Outcome Measures :
  1. Pain Score at 30 minutes [ Time Frame: 30 minutes ]
    The trial will compare the patient's pain score (0 to 10) at 30 minutes


Secondary Outcome Measures :
  1. Side Effects at 15 minutes, 30 minutes, and 60 minutes [ Time Frame: 15 minutes, 30 minutes, and 60 minute ]
    Side Effects of each trial group will be recorded at each time interval.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Emergency Medicine Patient
  • clinical diagnosis of acute renal colic
  • pain score of >=5 out of 10 on the numeric rating scale
  • - age 18 - 64 years of age

Exclusion Criteria:

  • documented or suspected pregnancy, breastfeeding
  • contraindication to nonsteroidal anti-inflammatory drugs or lidocaine
  • known renal dysfunction
  • received analgesics within 4 hours before presentation
  • history of bleeding diathesis
  • history of peptic ulcer disease
  • current use of warfarin
  • HR<50 or >150
  • history of cardiac arrhythmias
  • peritonitis or presence of any peritoneal sign
  • altered mental status
  • weight > 100kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902770


Sponsors and Collaborators
Antonios Likourezos
Investigators
Principal Investigator: Sergey Motov, MD Maimonides Medical Center

Publications:
Talati, J, Tiselius, H.-G, Albala, D.M, YE, Z. Urolithiasis: Basic Science and Clinical Practice. Springer Science & Business Media, Dec 22, 2012

Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02902770     History of Changes
Other Study ID Numbers: 2016-03-09
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Antonios Likourezos, Maimonides Medical Center:
Pain
Lidocaine
Ketorolac

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors