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Completed

NCT Number: NCT02912195

Intravenous Lidocaine Versus Morphine for Severe Pain in the ED

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alameda Health System, Highland Hospital

Oakland, California, 94602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Lidocaine

Drug

Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes

Other names: lignocaine, Xylocaine

intravenous morphine

Drug

Emergency department provider chooses appropriate dose of intravenous morphine

Other names: duramorph

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alameda Health System

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2016
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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