Intranasal Fentanyl Versus Intravenous Morphine in the Treatment of Severe Painful Sickle Cell Crises in Children

NCT03682211 | Completed Phase 4

• 3 other identifiers: SCC012011-005161-20ISRCTN67469672
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Sickle Cell Disease

Keywords

Sickle cell disease; Paediatric; Pain; Analgesia; Intranasal; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Pain score as measured using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler.

  Severity of pain as measured using a validated pain score (visual analogue scale) at 10 minutes after administration of the intervention. The the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler will be used as age-appropriate pain scales for pre-verbal/early verbal children and older verbal children respectively.

  10 minutes

Secondary Outcomes (2)

• Pain score as measured using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler.

  0, 5, 15, 20, 30, 60 and 120 minutes

• The proportion of participants requiring rescue opioid requirement.

  120 minutes

Study Arms (2)

Active Intranasal Fentanyl

EXPERIMENTAL

Subjects will receive 50 μg/ml intranasal fentanyl citrate and a placebo matched to intravenous morphine (1 ml water for injection) at time 0

Drug: Fentanyl Citrate

Active IV Morphine

ACTIVE COMPARATOR

Subjects will receive 10 mg/ml intravenous morphine sulphate and a placebo matched to intranasal fentanyl (2 ml water)

Drug: Morphine sulphate

Interventions

Fentanyl Citrate DRUG

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

Also known as: Fentanyl, Sublimaze

Active Intranasal Fentanyl

Morphine sulphate DRUG

10 mg/ml Morphine sulphate BP (Antigen Pharmaceuticals, Marketing Authorisation No.PA 73/20/1) administered intravenously.

Also known as: Morphine sulfate, Morphine

Active IV Morphine

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 1 - 21 years
• Weight ≥10 kg and ≤70 kg
• Known sickle cell disease presenting with severe pain
• Written informed consent, ideally from both parents (and assent, where appropriate), obtained prior to painful crisis (for example, in Haematology clinic)
• Verbal consent (and assent, where appropriate) obtained at the time of the painful crisis in the ED
• Hospital admission required for painful crisis

You may not qualify if:

• Patient has received parenteral narcotic analgesic within 4 hours of ED presentation
• Oxygen saturations below 95% on initial assessment
• Altered conscious state as defined by a Glasgow Coma score less than 15
• Contraindications to fentanyl/morphine usage
• Inability to secure IV access
• Patient has participated in another clinical trial involving an Investigation Medicinal Product (IMP) within 4 weeks of dosing, or is currently enrolled in another clinical trial involving an IMP, or has been previously enrolled in this trial
• Patients who have any condition that would make him/her, in the opinion of the Investigator or Sponsor, unsuitable for the study, or who are, in the opinion of the Investigator, not likely to complete the study for any reason
• Blocked or traumatised nose

Sponsors & Collaborators

• University College Dublin: lead
• National Children's Research Centre: collaborator
• Our Lady's Children's Hospital, Crumlin: collaborator

Study Sites (1)

Our Lady's Children's Hospital, Crumlin

Dublin, Ireland

Location

Related Publications (1)

• Barrett MJ, Cronin J, Murphy A, McCoy S, Hayden J, an Fhaili S, Grant T, Wakai A, McMahon C, Walsh S, O'Sullivan R. Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: study protocol for a randomised controlled trial. Trials. 2012 May 30;13:74. doi: 10.1186/1745-6215-13-74.

  PMID: 22647439 BACKGROUND

MeSH Terms

Conditions

Pain; Anemia, Sickle Cell; Agnosia

Interventions

Fentanyl; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All clinical and research staff, patients and parents are blinded to the treatment allocation. All study drugs will be packaged in blinded trial packs by a clinical trial pharmacist who is blinded to interventions and outcomes.The matched size and shape of the placebo ampoule is necessary to maintain blinding of intervention by the investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised, double-blind, double-dummy active control trial

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 24, 2018
• Study Start: December 12, 2012
• Primary Completion: November 14, 2013
• Study Completion: November 14, 2013
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

IE (1)