Intravenous Lidocaine Versus Morphine for Severe Pain in the ED

• 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: Alameda Health System
• Information provided by (Responsible Party): Eben Clattenburg, Alameda Health System

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

Alameda Health System, Highland Hospital

Oakland, California, United States, 94602

Sponsors and Collaborators

Alameda Health System

Investigators

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

More Information

• Responsible Party: Eben Clattenburg, Principle Investigator, Alameda Health System
• ClinicalTrials.gov Identifier: NCT02912195
• Other Study ID Numbers: 00001
• First Posted: September 23, 2016
• 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:

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