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Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Marc Fein, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01482091
First received: November 22, 2011
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.

Condition Intervention Phase
Anemia, Sickle Cell
Pain
Drug: Fentanyl Citrate
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Change in Pain Score 20 Minutes After Administration of Study Drug [ Time Frame: Baseline and 20 minutes after administration of study drug ] [ Designated as safety issue: No ]

    Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.

    To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points.



Secondary Outcome Measures:
  • Presence of Bradycardia [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
    Number of participants who had bradycardia

  • Presence of Headache [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ] [ Designated as safety issue: Yes ]
  • Admission Rate [ Time Frame: This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage ] [ Designated as safety issue: No ]
  • Length of Stay in ED [ Time Frame: Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours ] [ Designated as safety issue: No ]
    Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure

  • Total Amount of Narcotics Administered [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ] [ Designated as safety issue: No ]
    Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure

  • Time to Study Drug Administration [ Time Frame: Time from triage to adminstration of study drug ] [ Designated as safety issue: No ]
  • Change in Pain Score at 10 Minutes [ Time Frame: Baseline and 10 minutes after administration of study drug ] [ Designated as safety issue: No ]

    Change in pain score between 0 and 10 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.

    To calculate the change, the reported pain score at 10 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 10 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 10 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 10 minutes) representing a INCREASE in pain between the two time points.


  • Change in Pain Score at 30 Minutes [ Time Frame: Baseline and 30 minutes after administration of study drug ] [ Designated as safety issue: No ]

    Change in pain score between 0 and 30 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score, which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.

    To calculate the change, the reported pain score at 30 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 30 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 30 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 30 minutes) representing a INCREASE in pain between the two time points.


  • Change in Pain Score [ Time Frame: Baseline and immediately prior to IV insertion ] [ Designated as safety issue: No ]
    Due to confounding factors we were unable to obtain reliable data for this outcome

  • Respiratory Distress [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
    Participants who had respiratory distress within 30 min of study drug administration

  • Hypotension [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
    Participants who had hypotension within 30 min of study drug administration

  • Hypoxia [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
    Number of participants who had hypoxia within 30 min of study drug adminsitration


Enrollment: 124
Study Start Date: December 2011
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Intranasal Saline Drug: Normal Saline
A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
Experimental: Intranasal Fentnayl Drug: Fentanyl Citrate
A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device

Detailed Description:

Principles of therapy for treatment of vaso-occlusive crises include early aggressive analgesic therapy with opiates and non-steroidal anti-inflammatory agents as well as fluid administration. It is known that there is a significant delay in time to administration of analgesics in children with VOC in the ED. The most easily modifiable factor that contributes to delayed opiate administration is route of administration.

Intranasal medication administration is an easy, rapid way to administer opiates with minimal discomfort as well as bypassing first past metabolism and the blood brain barrier. Intranasal fentanyl has been shown to be a safe and effective analgesic for treatment of acute pain in children, reaching therapeutic effect in 2-10 minutes after administration.

The investigators believe that intranasal fentanyl therapy will be able to provide expedited and effective pain therapy to patients with sickle cell disease presenting to the pediatric emergency department with a vaso-occlusive crisis

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sickle Cell Disease
  • Ages 3 years - 21 years

Exclusion Criteria for Enrollment:

  • Pregnancy
  • Known allergy to Fentanyl
  • Usage of daily home opiates

Exclusion Criteria at presentation in ED with a painful crisis:

  • Wong Baker FACES Pain Score <6
  • Systolic blood pressure < 5 percentile for age
  • Oxygen saturation <92% on room air
  • Temperature > 102°F
  • Respiratory distress
  • Priapism
  • Isolated abdominal pain
  • Isolated headache
  • New neurological symptoms
  • Severe rhinorrhea or epistaxis
  • History of trauma
  • Pregnancy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482091

Locations
United States, New York
Children's Hospital at Montefiore
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Daniel M Fein, MD Children's Hospital at Montefiore
Study Director: Daniel M Fein, MD Children's Hospital at Montefiore
  More Information

Responsible Party: Daniel Marc Fein, Assistant Professor of Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01482091     History of Changes
Other Study ID Numbers: 11-09-343 
Study First Received: November 22, 2011
Results First Received: March 30, 2016
Last Updated: July 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
fentanyl
intranasal
sickle cell
vasoocclusive crisis
pain crisis
pediatrics

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Citric Acid
Fentanyl
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
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

ClinicalTrials.gov processed this record on December 09, 2016