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NOT YET RECRUITING
NCT07274254
PHASE3

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-03-01

Completion Date

2028-04-01

Last Updated

2025-12-26

Healthy Volunteers

No

Interventions

DRUG

Lidocain

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

DRUG

Placebo

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

Standard of care

Standard of care

Locations (11)

CHU Bordeaux

Bordeaux, France

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