MOOD - MethOxyflurane analgesia in vasoOcclusive crises of sickle cell Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Decision date (initial)

2026-05-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare the analgesic rapidity and efficiency of inhaled Methoxyflurane to oral administration of opioid analgesics, such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan®) as initial analgesic in SCD patients visiting emergency department for VOC.

Secondary objectives 6

1. Comparison of the patient's satisfaction between the two groups
2. Comparison of the nurse's satisfaction between the two groups
3. Comparison of the consumption of morphine and analgesics (Nefopam, Paracetamol, and Tramadol) until emergency discharge between the two groups.
4. Comparison of the duration of hospitalization between the two groups
5. Comparison of the total cost of both devices used in the study (Penthrox® and oral administration of opioid analgesics, such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan®)
6. Comparison of the occurrence of respiratory (occurrence of infection, acute chest syndrome), neurologic (occurrence of stroke), renal (occurrence of kidney failure) and hepatic (occurrence of Intrahepatic cholestasis or Cholelithiasis) events

Conditions and MedDRA coding

Sickle cell disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patient with sickle cell disease (SS, Sbeta0, SC or Sbéta+ genotypes)
2. Aged over eighteen years-old
3. Consulting the emergency department for vaso-occlusive crisis with pain intensity over 6 (moderate to severe pain) as measured using the VAS (Visual Analogic Scale)
4. Requiring intravenous morphine
5. For child-bearing aged women, efficient contraception
6. Social security affiliation
7. Informed consent (patient), with possibility of an emergency procedure with deferred written consent only if the pain is too strong and if prior oral consent obtained
8. French-speaking

Exclusion criteria 13

1. Refusal to participate
2. Previous inclusion in the MOOD study
3. Pregnant woman
4. Breast feeding
5. Patient under guardianship, administrative tutorship, deprived of liberty and incapable to giving informed consent
6. Inability to use Penthrox® or oral administration of opioid analgesics, such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan®) : patients who are unable to understand or comply with the mode of administration (cognitive impairment, altered level of consciousness, or physical limitations preventing self-administration)
7. Contraindication for Méthoxyflurane (Penthrox®)
8. Altered level of consciousness due to any cause; sleepiness
9. Clinically evident cardiovascular instability
10. Clinically evident respiratory depression
11. Acute chest syndrome suspected at admission: Chest pain and oxygen saturation under 95%.
12. Vital function failure requiring hospitalization in intensive care unit
13. Contraindication for oral administration of opioid analgesics, such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan®)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The mean pain intensity measured by VAS (Visual Analogic Scale) every 10 minutes during the first hour after admission in the emergency department

Secondary endpoints 9

1. Patient's satisfaction measured at the 60th minute by Likert scale ranging from 1 to 10.
2. Global ED nurse's satisfaction measured within the first 8h by Likert scale ranging from 1 to 10.
3. Total amount (in milligram) of intravenous morphine and analgesics (Nefopam, Paracetamol, and Tramadol) administered until emergency discharge
4. Duration of stay (in days) from arrival to emergency department to the end of hospitalization.
5. Calculation of the cost of Penthrox® (number of bottles used)
6. Calculation of the cost of oral administration of opioid analgesics (number of pills used), such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan® )
7. Incidence of renal and liver events based on the difference of kidney and liver function between the time of emergency admission and the third to seventh day of hospitalization (if several values are available, the worse value is retained)
8. Incidence of acute chest syndrome during hospitalization
9. Incidence of neurologic events such as ischemic stroke

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Richard CHOCRON

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Richard CHOCRON

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications