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Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

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ClinicalTrials.gov Identifier: NCT01482091
Recruitment Status : Completed
First Posted : November 30, 2011
Results First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Marc Fein, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE November 22, 2011
First Posted Date  ICMJE November 30, 2011
Results First Submitted Date  ICMJE March 30, 2016
Results First Posted Date  ICMJE August 19, 2016
Last Update Posted Date August 19, 2016
Study Start Date  ICMJE December 2011
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
Change in Pain Score 20 Minutes After Administration of Study Drug [ Time Frame: Baseline and 20 minutes after administration of study drug ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
Change in Pain Score 20 Minutes After Administration of Study Drug [ Time Frame: Baseline and 20 minutes after administration of study drug ]
Change History Complete list of historical versions of study NCT01482091 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
  • Presence of Bradycardia [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]
    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 ]
  • 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 ]
  • 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 ]
    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 ]
    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 ]
  • Change in Pain Score at 10 Minutes [ Time Frame: Baseline and 10 minutes after administration of study drug ]
    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 ]
    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 ]
    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 ]
    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 ]
    Participants who had hypotension within 30 min of study drug administration
  • Hypoxia [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]
    Number of participants who had hypoxia within 30 min of study drug adminsitration
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
  • Heart rate prior to and after the administration of study drug [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]
  • Presence of nausea, vomiting, itching and headache [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ]
  • 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 ]
  • 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 ]
  • Total Amount of Narcotics Administered [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ]
  • Time to Study Drug Administration [ Time Frame: Time from triage to adminstration of study drug, an expected average of 20 minutes ]
  • Change in Pain Score [ Time Frame: Baseline and 10 minutes after administration of study drug ]
  • Change in Pain Score [ Time Frame: Baseline and 30 minutes after administration of study drug ]
  • Change in Pain Score [ Time Frame: Baseline and immediately prior to IV insertion ]
  • Respiratory rate prior to and after the administration of study drug [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]
  • Blood Pressure prior to and after the administration of study drug [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]
  • Oxygen saturation prior to and after the administration of study drug [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
Official Title  ICMJE Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial
Brief Summary 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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia, Sickle Cell
  • Pain
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: Intranasal Saline
    Intervention: Drug: Normal Saline
  • Experimental: Intranasal Fentnayl
    Intervention: Drug: Fentanyl Citrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2015)
124
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2011)
200
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01482091
Other Study ID Numbers  ICMJE 11-09-343
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Marc Fein, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel M Fein, MD Children's Hospital at Montefiore
Study Director: Daniel M Fein, MD Children's Hospital at Montefiore
PRS Account Montefiore Medical Center
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP