Randomized Trial Evaluating Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis - RELIEF-SCC

Who is this study for? Patients in the emergency department for sickle cell crisis
What treatments are being studied? Lidocaine
Status: Unknown
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients \> 18 years old with sickle cell disease experiencing persistent severe (7-10/10) pain despite receiving at least one dose of intravenous opiate analgesic.

Locations
United States
New Jersey
Monmouth Medical Center
Long Branch
Robert Wood Johnson University Hospital
New Brunswick
Newark Beth Israel Medical Center
Newark
Contact Information
Primary
Andrew V Vassallo, PharmD
Andrew.Vassallo@rwjbh.org
732-557-8070
Backup
Shreni Zinzuwadia, MD
zinzuwsh@gmail.com
Time Frame
Start Date: 2024-01-01
Completion Date: 2025-06-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Lidocaine
Lidocaine 1.5mg/kg (Max: 200mg) in dextrose 5% 100mL over 10 minutes along with either morphine 0.1-0.15mg/kg IV OR hydromorphone 0.01-0.02mg/kg IV.
Placebo_comparator: Placebo
Dextrose 5% 100mL (placebo) over 10 minutes along with either morphine 0.1-0.15mg/kg IV OR hydromorphone 0.01-0.02mg/kg IV.
Sponsors
Leads: Community Medical Center, Toms River, NJ
Collaborators: Newark Beth Israel Medical Center, Rutgers Robert Wood Johnson Medical School, Monmouth Medical Center

This content was sourced from clinicaltrials.gov