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Intravenous Lidocaine Versus Morphine for Severe Pain in the ED

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ClinicalTrials.gov Identifier: NCT02912195
Recruitment Status : Completed
First Posted : September 23, 2016
Results First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Eben Clattenburg, Alameda Health System

Brief Summary:

Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider chosen dose of IV morphine for the treatment of severe pain in the emergency department.

Study design: Open-label, randomized controlled pilot study.


Condition or disease Intervention/treatment Phase
Pain Drug: Intravenous lidocaine Drug: Intravenous morphine Phase 4

Detailed Description:

Objective: The purpose of this pilot study is to determine the analgesic efficacy of intravenous lidocaine versus morphine for the treatment of severe pain in the emergency department (ED).

Study design: Open-label, randomized, controlled pilot trial. Participants: Investigators and research assistants will recruit patients ≥18 years old with severe pain (NRS ≥7) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed and 32 patients will be enrolled.

Intervention: After a trained research assistant obtains written informed consent, eligible participants will be randomized to the intravenous lidocaine or morphine arms of the study. In the intravenous lidocaine arm, patients will receive IV lidocaine (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg). In the morphine arm, the ED provider will choose an appropriate dose of morphine for the patient. At 20 and 40 minutes, the participants will be asked "Would you like additional pain medication?". Participants responding in the affirmative will receive morphine 4 mg IV.

Data collection: The trained research assistant will collect data on the patients' pain scores, side effects, and rescue morphine.

Statistical analysis: Investigators will perform descriptive statistics and compare pain scores and pain relief at each time point with unpaired t-tests.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Lidocaine Versus Provider Chosen Dose of Morphine for the Treatment of Severe Pain in the Emergency Department: An Open-label Randomized Controlled Pilot Study
Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous lidocaine

Participants will receive IV lidocaine (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) in a 100 mL normal saline minibag.

At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.

Drug: Intravenous lidocaine
Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes
Other Names:
  • lignocaine
  • Xylocaine

Active Comparator: Morphine

ED provider will choose an appropriate dose of intravenous morphine for the patient.

At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.

Drug: Intravenous morphine
Emergency department provider chooses appropriate dose of intravenous morphine
Other Name: duramorph




Primary Outcome Measures :
  1. Pain Score (NRS 0-10) [ Time Frame: At 60 minutes ]
    Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain.


Secondary Outcome Measures :
  1. Pain Score (NRS 0-10) [ Time Frame: At 10 minutes ]
    Pain score recorded on the numeric rating scale 0-10.

  2. Pain Score (NRS 0-10) [ Time Frame: At 20 minutes ]
    Pain score recorded on the numeric rating scale 0-10. 0 represents no pain and 10 represents the worst pain.

  3. Pain Score (NRS 0-10) [ Time Frame: At 30 minutes ]
    Pain score recorded on the numeric rating scale 0-10.

  4. Pain Score (NRS 0-10) [ Time Frame: At 40 minutes ]
    Pain score recorded on the numeric rating scale 0-10.

  5. Pain Score (NRS 0-10) [ Time Frame: At 50 minutes ]
    Pain score recorded on the numeric rating scale 0-10.

  6. Pain Relief at 10 Minutes Compared to Baseline. [ Time Frame: At 10 minutes ]
    Pain NRS at 0 minutes minus pain NRS at 10 minutes

  7. Pain Relief at 20 Minutes Compared to Baseline. [ Time Frame: at 20 minutes ]
    Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 20 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.

  8. Pain Relief at 30 Minutes Compared to Baseline. [ Time Frame: at 30 minutes ]
    Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 30 minutes NRS is a scale ranging from 0, no pain, to 10 worst pain.

  9. Pain Relief at 40 Minutes Compared to Baseline. [ Time Frame: At 40 minutes ]
    Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 40 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.

  10. Pain Relief at 50 Minutes Compared to Baseline. [ Time Frame: At 50 minutes ]
    Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 50 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.

  11. Pain Relief at 60 Minutes Compared to Baseline. [ Time Frame: At 60 minutes ]
    Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 60 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.

  12. Number of Participants Requiring Rescue Medications [ Time Frame: At 20 and 40 minutes ]
    The percentage of patients requiring rescue IV morphine at 20 and 40 minutes

  13. Patient Satisfaction [ Time Frame: 60 minutes ]
    The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?"

  14. Number of Participants Reporting Adverse Events [ Time Frame: 0-60 minutes ]
    Participants will be observed for the following adverse events and side effects: seizure, bradyarrhythmias, hyper or hypotension, perioral numbness, tinnitus, metallic taste, other, hypotension, hypoxia, nausea, vomiting, itching, or other side effects. Participants have the opportunity to report other side effects during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has severe pain (NRS ≥7)
  • Subject has anticipated ED stay of ≥1 hour

Exclusion Criteria:

  • High acuity trauma patients
  • Patients deemed to critically ill by ED provider
  • Active psychosis
  • Pregnancy
  • History of heart block or bradycardia
  • Allergy to lidocaine or amide type local anesthetic
  • History of seizures

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): NCT02912195


Locations
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United States, California
Alameda Health System, Highland Hospital
Oakland, California, United States, 94602
Sponsors and Collaborators
Alameda Health System
Investigators
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Principal Investigator: Andrew Herring, MD Alameda Health System, Highland Hospital
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Responsible Party: Eben Clattenburg, Principle Investigator, Alameda Health System
ClinicalTrials.gov Identifier: NCT02912195    
Other Study ID Numbers: 00001
First Posted: September 23, 2016    Key Record Dates
Results First Posted: April 6, 2020
Last Update Posted: April 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Lidocaine
Morphine
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
Analgesics, Opioid
Narcotics
Analgesics