IV Lidocaine for Sickle Cell Crisis
(RELIEF-SCC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether IV lidocaine, a pain relief medication, can reduce the need for opioids in individuals experiencing a sickle cell crisis. Sickle cell crisis causes severe pain, and while opioids are the usual treatment, they can lead to other issues. By adding IV lidocaine to the treatment plan, the study aims to determine if it can effectively relieve pain and decrease opioid use. Individuals with sickle cell disease who are currently experiencing severe pain, even after receiving opioids, might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on adding IV lidocaine to your existing opioid treatment for pain management.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that IV lidocaine can safely and effectively complement opioid treatments for managing pain during sickle cell crises. Studies have found it to be generally well-tolerated for this purpose. For instance, one study found that IV lidocaine was safe and improved pain management for patients experiencing painful blockages of blood flow. Another source highlights that incorporating IV lidocaine into a treatment plan was both safe and effective for better pain control.
Some reports mention longer hospital stays for patients receiving IV lidocaine, but this may result from other factors, such as the complexity of their condition, rather than the treatment itself. Overall, the available evidence suggests that IV lidocaine is a promising option for managing pain in sickle cell crises.12345Why do researchers think this study treatment might be promising for sickle cell crisis?
Most treatments for sickle cell crisis focus on managing pain with opioids like morphine or hydromorphone. However, this new approach adds IV lidocaine, typically used as a local anesthetic, to potentially provide rapid pain relief. Researchers are excited because lidocaine might work differently by directly affecting nerve signals, potentially reducing the need for high doses of opioids. This could lead to fewer side effects and a faster, more effective way to manage a sickle cell crisis.
What evidence suggests that IV lidocaine could be an effective treatment for sickle cell crisis?
Research has shown that IV lidocaine, which participants in this trial may receive, can help manage pain during a sickle cell crisis. Studies have found that using IV lidocaine with opioids reduces the amount of opioids needed for pain relief. This reduction is crucial in light of the current opioid crisis, as it means less dependence on opioids. Specifically, one study found that patients experienced less pain and used fewer opioids when IV lidocaine was part of their treatment. Additionally, IV lidocaine has proven to be safe and well-tolerated by patients. These findings suggest that IV lidocaine could effectively manage sickle cell pain.12567
Who Is on the Research Team?
Shreni Zinzuwadia, MD
Principal Investigator
Newark Beth Israel
Are You a Good Fit for This Trial?
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.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either lidocaine or placebo infusion along with opioid treatment for pain management during sickle cell crisis in the emergency department
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain scale assessments and opiate usage
What Are the Treatments Tested in This Trial?
Interventions
- Lidocaine Iv
- Placebo
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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.
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 Clinic Near You
Who Is Running the Clinical Trial?
Community Medical Center, Toms River, NJ
Lead Sponsor
Rutgers Robert Wood Johnson Medical School
Collaborator
Newark Beth Israel Medical Center
Collaborator
Monmouth Medical Center
Collaborator
Published Research Related to This Trial
Citations
Intravenous Lidocaine as an Adjuvant for Pain Associated ...
The authors conclude that adjuvant IV lidocaine provided pain relief and a mean reduction in MDE during sickle cell pain crisis.
2.
clinicaltrials.gov
clinicaltrials.gov/study/NCT04614610?term=AREA%5BBasicSearch%5D(Hemoglobinopathy%20Toms%20River)&rank=1Lidocaine Intravenous in the Emergency Department For ...
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 ...
3.
ashpublications.org
ashpublications.org/blood/article/138/Supplement%201/2962/478929/Implementation-of-an-Intravenous-LidocaineImplementation of an Intravenous Lidocaine Guideline for ...
This retrospective cohort study reviewed records of children with SCD age ≥10 years admitted for VOE at SLCH during 2018-2020. Data collected ...
Lidocaine and Ketamine Infusions as Adjunctive Pain ...
Conclusion: Both ketamine and lidocaine infusion therapies are effective in reducing opioid consumption for patients with vaso-occlusive crisis.
Implementation of an Intravenous Lidocaine Guideline for ...
In our cohort, IV lidocaine was safe, tolerable, and improved pain control. The care guideline was initiated within 24 hours for 78.7% of ...
Safety and Tolerability of Intravenous Lidocaine Infusions ...
Lidocaine infusions were associated with longer hospitalizations, potentially reflecting selection bias. The efficacy of adjuvant lidocaine infusions during VOE ...
Safety and Tolerability of Intravenous Lidocaine Infusions ...
Safety and Tolerability of Intravenous Lidocaine Infusions as Opioid Adjunct for Children Hospitalized With Sickle Cell Vaso-Occlusive Pain.
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