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IV Lidocaine for Sickle Cell Crisis (RELIEF-SCC Trial)

Phase 2
Waitlist Available
Led By Shreni Zinzuwadia, MD
Research Sponsored by Community Medical Center, Toms River, NJ
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Must not have
Patients presenting with or suspected to have acute chest syndrome
Patients < 18 years old and pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 and 90 minutes

Summary

This trial is testing whether giving IV lidocaine to people with sickle cell disease in addition to opioids will reduce pain and the overall amount of opioids needed.

Who is the study for?
This trial is for adults over 18 with sickle cell disease who are in severe pain (7-10/10) despite having had at least one dose of IV opioid painkillers. It's not for those under 18, pregnant women, patients with acute chest syndrome, or anyone allergic to lidocaine or morphine/hydromorphone.
What is being tested?
The study tests if IV lidocaine can help manage severe pain during a sickle cell crisis when added to standard opioid treatment in the emergency department. The goal is to see if it improves pain and reduces the need for opioids.
What are the potential side effects?
Lidocaine may cause side effects such as dizziness, numbness around the mouth, tingling sensations, low blood pressure, irregular heartbeats, sleepiness or confusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 with sickle cell disease and still have severe pain after IV pain medicine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am experiencing or suspected to have acute chest syndrome.
Select...
I am under 18 and pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 and 90 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 and 90 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in pain at 30 minutes
Secondary study objectives
% Patients requiring additional opiate administration
Change in visual analog pain scale (VAS, 0-10 with 10 being the most pain) at 60 and 90 minutes
Number of adverse effects of treatment
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: LidocaineActive Control1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Rutgers Robert Wood Johnson Medical SchoolOTHER
6 Previous Clinical Trials
17,862 Total Patients Enrolled
Community Medical Center, Toms River, NJLead Sponsor
5 Previous Clinical Trials
1,255 Total Patients Enrolled
Newark Beth Israel Medical CenterOTHER
11 Previous Clinical Trials
1,200 Total Patients Enrolled

Media Library

Lidocaine Clinical Trial Eligibility Overview. Trial Name: NCT04614610 — Phase 2
Sickle Cell Disease Research Study Groups: Lidocaine, Placebo
Sickle Cell Disease Clinical Trial 2023: Lidocaine Highlights & Side Effects. Trial Name: NCT04614610 — Phase 2
Lidocaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04614610 — Phase 2
~8 spots leftby Jan 2025
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