Not Authorised Therapeutic confirmatory (Phase III) Sickle cell disease

MOOD - MethOxyflurane analgesia in vasoOcclusive crises of sickle cell Disease

EU CTIS ID: 2024-518043-38-00

What this study is testing

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.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patient with sickle cell disease (SS, Sbeta0, SC or Sbéta+ genotypes)
  • Aged over eighteen years-old
  • 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)
  • Requiring intravenous morphine
  • For child-bearing aged women, efficient contraception
  • Social security affiliation

You likely can't join if

  • Refusal to participate
  • Clinically evident respiratory depression
  • Acute chest syndrome suspected at admission: Chest pain and oxygen saturation under 95%.
  • Vital function failure requiring hospitalization in intensive care unit
  • Contraindication for oral administration of opioid analgesics, such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan®)
  • Previous inclusion in the MOOD study
See the full eligibility criteria
Who can join
  • Patient with sickle cell disease (SS, Sbeta0, SC or Sbéta+ genotypes)
  • Aged over eighteen years-old
  • 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)
  • Requiring intravenous morphine
  • For child-bearing aged women, efficient contraception
  • Social security affiliation
  • 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
  • French-speaking
What rules you out
  • Refusal to participate
  • Clinically evident respiratory depression
  • Acute chest syndrome suspected at admission: Chest pain and oxygen saturation under 95%.
  • Vital function failure requiring hospitalization in intensive care unit
  • Contraindication for oral administration of opioid analgesics, such as Oral Oxycodone Hydrochloride (OxynormORO®) or Morphine Sulfate (Actiskenan®)
  • Previous inclusion in the MOOD study
  • Pregnant woman
  • Breast feeding
  • Patient under guardianship, administrative tutorship, deprived of liberty and incapable to giving informed consent
  • 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)
  • Contraindication for Méthoxyflurane (Penthrox®)
  • Altered level of consciousness due to any cause; sleepiness
  • Clinically evident cardiovascular instability

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.