• Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis

  NCT04614610

  Unknown statusInterventionalPhase 2Updated Aug 29, 2023
• Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease

  NCT02222246

  CompletedInterventionalPhase 4Updated Aug 4, 2017
• Pain Management in Children and Young Adults With Sickle Cell Disease

  NCT01954927

  CompletedInterventionalPhase 2Updated Apr 2, 2019
• Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.

  NCT04076748

  TerminatedInterventionalPhase 3Updated Jun 22, 2026
• Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric

  NCT06181695

  Not yet recruitingInterventionalPhase 3Updated Dec 26, 2023
• Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally

  NCT01380197

  CompletedInterventionalPhase 3Updated Feb 20, 2018

ClinicalTrials.gov ID

NCT07274254

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

104Estimated

Last Update Posted

Jul 13, 2026Actual

Start Date

Jul 3, 2026Actual

Primary Completion Date

Aug 3, 2028Estimated

Completion Date

Aug 3, 2028Estimated

Official Title

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

Brief 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.

• Vaso-Occlusive Pain Episode in Sickle Cell Disease

• Lidocain
• Placebo
• Standard of care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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:

  • Vaso-Occlusive Crisis defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or pelvis, not attributable to other causes
  • Acute Chest Syndrome defined by the association of clinical respiratory sign(s): dyspnea and/or chest pain and/or auscultatory abnormality (crepitants and/or bronchial breathing) with a new pulmonary infiltrate on chest X-ray, thoracic CT-scan, or lung ultrasound.

• 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:

• Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
• Patients under guardianship, curatorship or under legal protection
• Prisoners or subjects who are involuntarily incarcerated
• Sickle Cell Disease acute complication other than Vaso-Occlusive Crisis or Acute Chest Syndrome as the main reason for admission:

priapism, stroke, acute splenic sequestration, acute hepatic sequestration, bone marrow necrosis…

• Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion
• Known or assumed hypersensitivity to lidocaine hydrochloride, other local anaesthetics (e.g., bupivacaine or ropivacaine) or an excipient
• Patients treated with anti-arhythmic drugs known to induce torsade de pointe.
• Patients on chronic or occasional treatment with drugs that interact with the 3A cytochrome isoenzymes (CYP3A) and/or 1A2 cytochrome isoenzymes (CYP1A2)
• Patients with recurrent porphyria, porphyria in remission, or known asymptomatic carriage of gene mutations responsible for porphyria
• Epileptic patients
• Hypovolemic shock or shock of other cause at screening for inclusion
• Known atrioventricular block, QT prolongation or other heart conduction disorder or heart failure
• Chronic respiratory failure with long term non invasive ventilation (excluding Continuous Positive Air way pressure), or long term oxygen therapy at home
• Acute Respiratory Distress Syndrome according to The 2012 Berlin definition
• Acute or Chronic liver failure with MELD > 19 according to CKD-EPI
• Acute or Chronic kidney failure with clearance <30mL/min/m2
• Body weight <40kg and >120kg
• Prior inclusion in the study in the last 3 months
• Patient under invasive mechanical ventilation
• Altered consciousness with Glasgow coma scale <13

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Nantes University HospitalOTHER

arthur.durand@chu-lille.fr03.20.44.40.84 ext. +33

maite.agbakou@chu-nantes.fr02.40.76.80.54 ext. +33

maximilien.grall@chu-rouen.fr02.32.88.58.28 ext. +33