Intranasal Fentanyl Versus Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children
Condition: Pain; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      Sickle cell anaemia is an inherited blood disorder which results in abnormal sickle shaped
      red blood cells which do not fit well through small blood vessels. These blockages prevent
      oxygen (in blood) from reaching different parts of the body resulting in painful crisis. This
      study will compare the effectiveness of two types of pain medication, one given through a
      vein and one squirted up the nose.
    

Detailed description: 
      Children with sickle cell disease (SCD) frequently and unpredictably present to the emergency
      department (ED) with pain. The painful event is the hallmark acute clinical manifestation of
      SCD, characterised by sudden onset and is usually bony in origin. This study aims to
      establish if 1.5mcg/kg of intranasal fentanyl (INF; administered via a Mucosal Atomiser
      Device, MAD™) is non-inferior to intravenous morphine 0.1 mg/kg in severe SCD-associated
      pain.

      This study is a randomised,double-blind, double-dummy active control trial of children
      (weighing more than 10 kg) between 1 year and 21 years of age with severe painful sickle cell
      crisis. Severe pain is defined as rated seven or greater on a 0 to 10 age-appropriate numeric
      pain scale or equivalent. The trial will be conducted in a single tertiary urban paediatric
      ED in Dublin, Ireland. Each patient will receive a single active agent and a single placebo
      via the intravenous and intranasal routes. All clinical and research staff, patients and
      parents will be blinded to the treatment allocation. The primary endpoint is severity of pain
      scored at 10 min from administration of the study medications. Secondary endpoints include
      pain severity measured at 0, 5, 15, 20, 30, 60 and 120 min after the administration of
      analgesia, proportion of patients requiring rescue analgesia and incidence of adverse events.
      The trial ends at 120 min after the administration of the study drugs. A clinically
      meaningful difference in validated pain scores has been defined as 13 mm. Setting the
      permitted threshold to 50% of this limit (6 mm) and assuming both treatments are on average
      equal, a sample size of 30 patients (15 per group) will provide at least 80% power to
      demonstrate that INF is non-inferior to IV morphine with a level of significance of 0.05.

      This clinical trial will inform of the role of INF 1.5mcg/kg via MAD in the acute treatment
      of severe painful sickle cell crisis in children in the ED setting.
    

Intervention name(s): Fentanyl Citrate; Morphine sulphate
Intervention type(s): Drug; Drug
Intervention description(s): 50 μg/ml fentanyl citrate (Sublimaze, Janssen Cilag, Ltd, Marketing Authorisation No. PA 0748/044/001) administered intranasally using the MAD Nasal Intranasal Mucosal Atomiser Device; 10 mg/ml Morphine sulphate BP (Antigen Pharmaceuticals, Marketing Authorisation No.PA 73/20/1) administered intravenously.
Other intervention name(s): Fentanyl; Sublimaze; Morphine sulfate; Morphine
Intervention MeSH terms: Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised, double-blind, double-dummy active control trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sickle cell disease; Paediatric; Pain; Analgesia; Intranasal; Fentanyl