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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
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. * Bolus of 1.5 mg/kg bolus during 30 minutes, with a maxium dose of 180 mg (18mL) * Immediately followed by a continuous infusion of 1 mg/kg/h (max 120mg/h = 12mL/h) during 72 hours.
Standard of care
CHU Bordeaux
Bordeaux, France
CHU Lille
Lille, France
CHU La Timone
Marseille, France
CHU de Nantes
Nantes, France
Cumulative parenteral opioid dose between randomization and discharge from the intensive care unit expressed in morphine milligram equivalent.
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
Intensive Care Unit length of stay
Time frame: up to 28 days
hospital length of stay
Time frame: up to 28 days
Visual analogue pain Scale score during Intensive Care Unit stay
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
Categorical Pain Score during Intensive Care Unit stay
Compare between groups the pain intensity as evaluated using Categorical Pain Score (CPS)
Time frame: up to 28 days
Time of resolution of severe vaso-occlusive crisis
presence of at least three of the following four criteria: * continuous apyrexia for the last 8 hours, * no need for intravenous opioid infusion for the last 8 hours, * ability to walk or move without pain, * absence of spontaneous pain with a CPS ≤1
Time frame: up to 28 days
time to last parenteral opioid dose
Time from randomisation to the last parenteral opioid dose
Time frame: up to 28 days
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CHU Orléans
Orléans, France
Hôpital Tenon APHP
Paris, France
CHU Poitiers
Poitiers, France
CHU Rouen
Rouen, France
Oncopole Toulouse
Toulouse, France
CHRU Tours - Hôpital Bretonneau
Tours, France
...and 1 more locations
vaso-occlusive crisis complications during Intensive Care Unit stay
secondary acute chest syndrome
Time frame: up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay
need for blood transfusion
Time frame: up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay
need for red blood cell exchange
Time frame: up to 28 days
vaso-occlusive crisis complications during Intensive Care Unit stay
need for life-supporting therapies defined as invasive mechanical ventilation or dialysis or vasopressor support
Time frame: up to 28 days
quality of life with reduced impact of Sickle Cell Disease on health
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 Day 28
safety profile of lidocaine infusion
Compare between groups safety profile of lidocaine infusion at D28
Time frame: at 28 days
Rate of readmission for vaso-occlusive crisis after Intensive Care Unit discharge
Frequency of any adverse events and frequency of serious adverse events
Time frame: At day 28
Assess the economic efficiency of lidocaine added to standard of care compared to standard of care alone
Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY) comparing lidocaine + standard of care (SOC) to SOC alone
Time frame: At day 28