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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group: Lidocaine + standard of care | Experimental | Lidocaine hydrochloride 20 mg/mL, solution, 20 mL ampoule for intravenous administration Administration : parenteral route on peripheral or central venous catheter.
|
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| Control group: placebo + standard of care | Placebo Comparator | Placebo is 20 mL ampoules of sodium chloride (NaCl 0.9%) for injection. Administration : parenteral route on peripheral or central venous catheter.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocain | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit length of stay | up to 28 days | |
| hospital length of stay | up to 28 days | |
| Visual analogue pain Scale score during Intensive Care Unit stay |
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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:
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:
priapism, stroke, acute splenic sequestration, acute hepatic sequestration, bone marrow necrosis…
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maïté AGBAKOU | Contact | 02.44.76.80.54 | +33 | maite.agbakou@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France |
|
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000098644 | Vaso-Occlusive Crises |
| D056586 | Acute Chest Syndrome |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Controlled, radomized, Double blinded, Prospective, Superiority
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| Placebo | Drug | 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 | Drug | Standard of care |
|
Compare between groups the pain intensity as evaluated using a Visual Analogue pain Scale from 0 (no pain) to 10 (very intense pain). |
| 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) | up to 28 days |
| Time of resolution of severe vaso-occlusive crisis | presence of at least three of the following four criteria:
| up to 28 days |
| time to last parenteral opioid dose | Time from randomisation to the last parenteral opioid dose | up to 28 days |
| vaso-occlusive crisis complications during Intensive Care Unit stay | secondary acute chest syndrome | up to 28 days |
| vaso-occlusive crisis complications during Intensive Care Unit stay | need for blood transfusion | up to 28 days |
| vaso-occlusive crisis complications during Intensive Care Unit stay | need for red blood cell exchange | 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 | 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. | At Day 28 |
| safety profile of lidocaine infusion | Compare between groups safety profile of lidocaine infusion at D28 | 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 | 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 | At day 28 |
| CHU Lille | Lille | France |
|
| CHU La Timone | Marseille | France |
| CHU de Nantes | Nantes | France |
|
| 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 |
|
| CHU Guadeloupe | Les Abymes | Guadeloupe |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |