Intravenous Lidocaine Versus Morphine for Severe Pain in the ED

NCT ID: NCT02912195

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-09-30

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intravenous lidocaine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Intravenous morphine

Intervention Type: DRUG

Emergency department provider chooses appropriate dose of intravenous morphine

Interventions

Intravenous lidocaine

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

Intervention Type: DRUG

Intravenous morphine

Emergency department provider chooses appropriate dose of intravenous morphine

Intervention Type: DRUG

Other Intervention Names

lignocaine; Xylocaine; duramorph

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alameda Health System

OTHER

Sponsor Role: lead

Responsible Party

Eben Clattenburg

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Herring, MD

Role: PRINCIPAL_INVESTIGATOR

Alameda Health System, Highland Hospital

Locations

Alameda Health System, Highland Hospital

Oakland, California, United States

Countries

United States

Other Identifiers

00001

Identifier Type: -

Identifier Source: org_study_id