Evaluating Intravenous Lidocaine Added to Standard Care to Reduce Opioid Use During Severe Pain Crises in Adults With Sickle Cell Disease

What this Trial Is About

Researchers are evaluating whether adding lidocaine to the standard pain management for adults experiencing severe vaso-occlusive crises in sickle cell disease can reduce the total opioid use during these painful episodes. This phase 3 trial focuses on adults admitted to intensive care with vaso-occlusive crisis or acute chest syndrome, aiming to understand the impact on opioid consumption expressed as morphine milligram equivalents. Participants are randomly assigned to receive either intravenous lidocaine or a placebo, both given as an initial bolus followed by a continuous infusion over 72 hours, alongside standard care for pain management. The lidocaine is administered as a 1.5 mgkg bolus over 30 minutes, then a continuous infusion of 1 mgkg per hour, with maximum doses specified. The placebo group receives a similar volume of sodium chloride solution. The study monitors treatment effects during hospital intensive care and up to 28 days following randomization. Throughout the study, participants undergo regular assessments including pain scales, opioid usage tracking, length of stay in intensive care and hospital, and evaluations of crisis resolution and complications. Quality of life and safety profiles related to lidocaine infusion are also measured at 28 days. The primary outcome is total opioid consumption up to intensive care discharge. Participants remain under close observation, with data collected on readmissions and economic factors related to adding lidocaine to standard care.

Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease