Intravenous Lidocaine Versus Morphine for Severe Pain in the ED

Alameda Health System

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Intravenous lidocaine; Drug: Intravenous morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02912195

00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Intravenous lidocaine

Experimental group

Description:

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.

Treatment:

Drug: Intravenous lidocaine

Morphine

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous morphine