Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682211
Recruitment Status : Completed
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Collaborators:
National Children's Research Centre
Our Lady's Children's Hospital, Crumlin
Information provided by (Responsible Party):
University College Dublin

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.

Condition or disease Intervention/treatment Phase
Pain Sickle Cell Disease Drug: Fentanyl Citrate Drug: Morphine sulphate Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised, double-blind, double-dummy active control trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Intranasal Fentanyl Versus Intravenous Morphine in the Emergency Department Treatment of Severe Painful Sickle Cell Crises in Children
Actual Study Start Date : December 12, 2012
Actual Primary Completion Date : November 14, 2013
Actual Study Completion Date : November 14, 2013


Arm Intervention/treatment
Experimental: Active Intranasal Fentanyl
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
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
Other Names:
  • Fentanyl
  • Sublimaze

Active Comparator: Active IV Morphine
Subjects will receive 10 mg/ml intravenous morphine sulphate and a placebo matched to intranasal fentanyl (2 ml water)
Drug: Morphine sulphate
10 mg/ml Morphine sulphate BP (Antigen Pharmaceuticals, Marketing Authorisation No.PA 73/20/1) administered intravenously.
Other Names:
  • Morphine sulfate
  • Morphine




Primary Outcome Measures :
  1. Pain score as measured using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler. [ Time Frame: 10 minutes ]
    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.


Secondary Outcome Measures :
  1. Pain score as measured using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale and Manchester Pain Ruler. [ Time Frame: 0, 5, 15, 20, 30, 60 and 120 minutes ]
    Severity of pain as measured using a validated pain score (visual analogue scale) at 0, 5, 15, 20, 30, 60 and 120 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.

  2. The proportion of participants requiring rescue opioid requirement. [ Time Frame: 120 minutes ]
    The proportion of patients requiring rescue opioid analgesia.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682211


Locations
Layout table for location information
Ireland
Our Lady's Children's Hospital, Crumlin
Dublin, Ireland
Sponsors and Collaborators
University College Dublin
National Children's Research Centre
Our Lady's Children's Hospital, Crumlin

Publications:
Layout table for additonal information
Responsible Party: University College Dublin
ClinicalTrials.gov Identifier: NCT03682211    
Other Study ID Numbers: SCC01
2011-005161-20 ( EudraCT Number )
ISRCTN67469672 ( Registry Identifier: ISRCTN )
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University College Dublin:
Sickle cell disease
Paediatric
Pain
Analgesia
Intranasal
Fentanyl
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Fentanyl
Morphine
Citric Acid
Sodium Citrate
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action