Lidocain
DrugLidocaine hydrochloride 20 mg/mL, solution, 20 mL ampoule for IV administration (25 ampoules) Administration : parenteral route on peripheral or central venous catheter. - Bolus of 1.5 mg/kg bolus dur
NCT Number: NCT07274254
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
CHU Bordeaux, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
priapism, stroke, acute splenic sequestration, acute hepatic sequestration, bone marrow necrosis…
Lidocaine hydrochloride 20 mg/mL, solution, 20 mL ampoule for IV administration (25 ampoules) Administration : parenteral route on peripheral or central venous catheter. - Bolus of 1.5 mg/kg bolus dur
Placebo is 20 mL ampoules of sodium chloride (NaCl 0.9%) for injection Administration : parenteral route on peripheral or central venous catheter.
Standard of care
Time frame: up to 28 days
To determine whether adding lidocaine to the standard of care in pain during severe vaso-occlusive crisis has an effect on the cumulative opioid consumption expressed as morphine milligram equivalent (MME)
Time frame: up to 28 days
Time frame: up to 28 days
Time frame: up to 28 days
Compare between groups the pain intensity as evaluated using a Visual Analogue pain Scale from 0 (no pain) to 10 (very intense pain).
Time frame: up to 28 days
Compare between groups the pain intensity as evaluated using Categorical Pain Score (CPS)
Time frame: up to 28 days
presence of at least three of the following four criteria:
Time frame: up to 28 days
Time from randomisation to the last parenteral opioid dose
Time frame: up to 28 days
secondary acute chest syndrome
Time frame: up to 28 days
need for blood transfusion
Time frame: up to 28 days
need for red blood cell exchange
Time frame: up to 28 days
need for life-supporting therapies defined as invasive mechanical ventilation or dialysis or vasopressor support
Time frame: At Day 28
Score of French version of Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me).
It is a patient-reported outcome measurement system with a 39 items questionnaire, assessing several aspects of SCD impact on general health state. For the present study, the questionnaires regarding emotional impact, pain episodes, pain impact, Social Functionning will be used.
Time frame: at 28 days
Compare between groups safety profile of lidocaine infusion at D28
Time frame: At day 28
Frequency of any adverse events and frequency of serious adverse events
Time frame: At day 28
Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY) comparing lidocaine + standard of care (SOC) to SOC alone
Contact information is provided by the study sponsor or research team.
Nantes University Hospital
Other
Acronym: LidoVOC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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