Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease (NCT07274254) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease
France104 participantsStarted 2026-03-01
Plain-language summary
The purpose of the study is to determine whether adding lidocaine to standard of care in pain management during severe vaso-occlusive crisis has an effect on the cumulative opioid consumption expressed as morphine milligram equivalent.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>= 18 years
* Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype
* Patient admitted to the Intensive Care Unit for Vaso-Occlusive Crisis and/or ACS as the main reason for admission:
* Vaso-Occlusive Crisis defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or pelvis, not attributable to other causes
* Acute Chest Syndrome defined by the association of clinical respiratory sign(s): dyspnea and/or chest pain and/or auscultatory abnormality (crepitants and/or bronchial breathing) with a new pulmonary infiltrate on chest X-ray, thoracic CT-scan, or lung ultrasound.
* Treatment with parenteral morphine or oxycodone started less than 72 hours prior to inclusion
* Patient or next of kin informed about the study and having consented to the participation of the patient in the study. If patient is no competent and no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the Intensive Care Unit physician, in compliance with French law.
* French speaking
* Patient with health care insurance
Exclusion Criteria:
* Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
* Patients under guardianship, curatorship or under legal protection
* Prisoners or subjects who are involuntarily incarcerated
* Sickle Cell Disease acute complication o…
What they're measuring
1
Cumulative parenteral opioid dose between randomization and discharge from the intensive care unit expressed in morphine milligram equivalent.