Trials Sponsors Conditions Drugs Pricing

Conditions

Sickle cell disease Vaso-Occlusive Pain Episode in Sickle Cell Disease

Keywords

Sickle Cell diseaseSickle Cell SyndromeVaso-occlusive crisisAcute Chest SyndromePainful crisisPain managementOpioid sparingLidocaine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (14)

Intensive Care Unit length of stay
up to 28 days
hospital length of stay
up to 28 days

Study Arms (2)

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. * Bolus of 1.5 mg/kg bolus during 30 minutes, with a maximum dose of 180 mg (18mL) * Immediately followed by a continuous infusion of 1 mg/kg/h (max 120mg/h =- 12mL/h) during 72 hours.

Drug: LidocainDrug: Standard of care

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. * 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.

Drug: PlaceboDrug: Standard of care

Interventions

LidocainDrug

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

Experimental group: Lidocaine + standard of care

PlaceboDrug

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.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
LIDOCAINE HYDROCHLORIDE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

LIDOCAINE HYDROCHLORIDE
Named ingredient: Lidocaine hydrochloride
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age \>= 18 years
Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype

Sponsors & Collaborators

Centre Hospitalier Universitaire De Nantes
Type not reportedlead
Nantes University Hospital
Otherlead

Study Sites (12)

CHU Bordeaux

Bordeaux, France

RECRUITING

Arthur ORIEUXCONTACT05.56.79.56.79 ext. +33 arthur.orieux@chu-bordeaux.fr

CHU de Bordeaux - Hôpital Saint-André

Bordeaux, France

RECRUITING

Renaud PREVELCONTACT0562773545 renaud.prevel@chu-bordeaux.fr

MeSH Terms

Conditions

Anemia, Sickle CellVaso-Occlusive CrisesAcute Chest SyndromeAgnosia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung Diseases

Central Study Contacts

Maïté AGBAKOU

CONTACT

02.44.76.80.54 maite.agbakou@chu-nantes.fr

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 10, 2025

Study Start

July 3, 2026

Actual (reported)

Primary Completion

Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (2)

Experimental group: Lidocaine + standard of care

Control group: placebo + standard of care

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (2)

Experimental group: Lidocaine + standard of care

Control group: placebo + standard of care

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (12)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source records

Locations