Intravenous Lidocaine Versus Morphine for Severe Pain in the ED

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Intravenous lidocaine; Drug: Intravenous morphine

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94602
      • Alameda Health System, Highland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Xylocaine; lignocaine
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 Names: duramorph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (NRS 0-10)	Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain.	At 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (NRS 0-10)	Pain score recorded on the numeric rating scale 0-10.	At 10 minutes
Pain Score (NRS 0-10)	Pain score recorded on the numeric rating scale 0-10. 0 represents no pain and 10 represents the worst pain.	At 20 minutes
Pain Score (NRS 0-10)	Pain score recorded on the numeric rating scale 0-10.	At 30 minutes
Pain Score (NRS 0-10)	Pain score recorded on the numeric rating scale 0-10.	At 40 minutes
Pain Score (NRS 0-10)	Pain score recorded on the numeric rating scale 0-10.	At 50 minutes
Pain Relief at 10 Minutes Compared to Baseline.	Pain NRS at 0 minutes minus pain NRS at 10 minutes	At 10 minutes
Pain Relief at 20 Minutes Compared to Baseline.	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.	at 20 minutes
Pain Relief at 30 Minutes Compared to Baseline.	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.	at 30 minutes
Pain Relief at 40 Minutes Compared to Baseline.	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.	At 40 minutes
Pain Relief at 50 Minutes Compared to Baseline.	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.	At 50 minutes
Pain Relief at 60 Minutes Compared to Baseline.	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.	At 60 minutes
Number of Participants Requiring Rescue Medications	The percentage of patients requiring rescue IV morphine at 20 and 40 minutes	At 20 and 40 minutes
Patient Satisfaction	The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?"	60 minutes
Number of Participants Reporting Adverse Events	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	0-60 minutes

Collaborators and Investigators

• Sponsor: Alameda Health System
• Investigators: Principal Investigator: Andrew Herring, MD, Alameda Health System, Highland Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (ESTIMATE): September 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Morphine
• Other Study ID Numbers: 00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED