Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis

Summary

Sickle cell crisis continues to be a frequent presentation to emergency departments. Patients presenting will often require immediate treatment for their pain and often times this will include opioids. The opioid epidemic has cost thousands of lives; and continues to be a significant problem posing several challenges when treating patients presenting with sickle cell disease. Primarily, opioids remain the mainstay of treatment for these patients and the push to address the opioid crisis may present challenges for adequate opioid administration in patients suffering from a sickle cell crisis while hospitals find ways to curb the opioid crisis overall. Opioid treatment for patients in acute vaso-occlusive crisis has significantly contributed to quality of life and life expectancy of patients with this diagnosis. Measures should continue to attempt to administer a multi-model approach to sickle cell patients to minimize the morphine milligram equivalents in these patients while also successfully addressing the patient's pain. IV lidocaine is a pain medication that has been evaluated in several painful experiences, such as in renal colic. A few case reports have shown IV lidocaine use in sickle cell can be a potential effective adjunct medication to opioids to treat pain and reduce further opioid requirements. Currently, no prospective controlled trial exists to evaluate the true benefit of IV lidocaine in this population. Our study aims to evaluate IV lidocaine as an adjunct to opioid treatment in the emergency department to determine if improved pain is achieved and if there is a reduction in overall morphine milligram equivalents throughout the emergency department visit.

Conditions

• Sickle Cell Disease
• Sickle Cell Crisis
• Pain, Acute

Interventions

DRUG

Lidocaine Iv

Lidocaine 1.5mg/kg (Max dose: 200mg) in Dextrose 5% 100mL over 10 minutes

DRUG

Placebo

Dextrose 5% 100mL over 10 minutes

Sponsors & Collaborators

• Newark Beth Israel Medical Center

  collaborator OTHER

• Monmouth Medical Center

  collaborator OTHER

• Rutgers Robert Wood Johnson Medical School

  collaborator OTHER

• Community Medical Center, Toms River, NJ

  lead OTHER

Principal Investigators

• Shreni Zinzuwadia, MD · Newark Beth Israel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2025-01-02

Completion

2025-06-01

FDA Drug

Yes

Countries

• United States

Study Locations