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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
Results First Received: March 30, 2016  
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
Conditions: Anemia, Sickle Cell
Pain
Interventions: Drug: Fentanyl Citrate
Drug: Normal Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Subjects were PRE-CONSENTED for the study in the outpatient hematology clinic, inpatient floors prior to discharge or a separate emergency department (ED) visit prior to discharge. This was done to prevent decision making while under emotional duress of a vaso-occlusive crisis (VOC).

PRE-CONSENT occurred from 12.12.2011-1.8.2015


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
124 subjects were consented for the study. The study drug was only administered one time in the ED if subjects met all inclusion and exclusion criteria when they arrived with a VOC. Only 49 of the 124 consented subjects received the study drug.

Reporting Groups
  Description
Intranasal Saline 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.
Intranasal Fentnayl 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

Participant Flow:   Overall Study
    Intranasal Saline   Intranasal Fentnayl
STARTED   25   24 
COMPLETED   25   24 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Intranasal Saline 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.
Intranasal Fentnayl 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
Total Total of all reporting groups

Baseline Measures
   Intranasal Saline   Intranasal Fentnayl   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   24   49 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.5  (5.1)   10.6  (5.3)   11.6  (5.2) 
Gender 
[Units: Participants]
     
Female   6   13   19 
Male   19   11   30 
weight 
[Units: Kg]
Median (Inter-Quartile Range)
 45 
 (29 to 70) 
 28 
 (24 to 52.5) 
 37 
 (24.5 to 64) 
Type of Sickle Cell Disease [1] 
[Units: Participants]
     
SS   19   20   39 
SC   6   3   9 
SB   0   1   1 
[1] SS, SC and SB refer to different genotypes of sickle cell disease, commonly referred to as Hemoglobin SS, Hemoglobin SC and Hemoglobin S/Beta thalassemia, respectively
Duration of VOC 
[Units: Participants]
     
<1/2 day   7   9   16 
1/2-1day   5   7   12 
1-2 day   6   4   10 
>2 day   7   4   11 
Location of VOC 
[Units: Participants]
     
Abdomen   6   10   16 
Back   12   12   24 
Chest   4   7   11 
Head   1   4   5 
Arms   5   9   14 
Legs   12   10   22 
Oral analgesic within 2h prior to study drug 
[Units: Participants]
 2   3   5 


  Outcome Measures
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1.  Primary:   Change in Pain Score 20 Minutes After Administration of Study Drug   [ Time Frame: Baseline and 20 minutes after administration of study drug ]

2.  Secondary:   Presence of Bradycardia   [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]

3.  Secondary:   Presence of Headache   [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   Total Amount of Narcotics Administered   [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ]

7.  Secondary:   Time to Study Drug Administration   [ Time Frame: Time from triage to adminstration of study drug ]

8.  Secondary:   Change in Pain Score at 10 Minutes   [ Time Frame: Baseline and 10 minutes after administration of study drug ]

9.  Secondary:   Change in Pain Score at 30 Minutes   [ Time Frame: Baseline and 30 minutes after administration of study drug ]

10.  Secondary:   Change in Pain Score   [ Time Frame: Baseline and immediately prior to IV insertion ]

11.  Secondary:   Respiratory Distress   [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]

12.  Secondary:   Hypotension   [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]

13.  Secondary:   Hypoxia   [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Daniel Fein
Organization: Albert Einstein College of Medicine/Children's Hospital at Montefiore
phone: 718-920-5312
e-mail: dfein@montefiore.org



Responsible Party: Daniel Marc Fein, 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