Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age >= 18 years
Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype
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.
Disqualifiers
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
Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion
Trial design
Treatments tested in this trial
- Lidocain
- Placebo
- Standard of care
Treatment groups
104 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov