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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Anemia, Sickle Cell
Pain
Interventions Drug: Fentanyl Citrate
Drug: Normal Saline
Enrollment 124

Recruitment Details

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 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.
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description 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. 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
Period Title: Overall Study
Started 25 24
Completed 25 24
Not Completed 0 0
Arm/Group Title Intranasal Saline Intranasal Fentnayl Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 25 24 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 24 participants 49 participants
12.5  (5.1) 10.6  (5.3) 11.6  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
Female
6
  24.0%
13
  54.2%
19
  38.8%
Male
19
  76.0%
11
  45.8%
30
  61.2%
weight  
Median (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 25 participants 24 participants 49 participants
45
(29 to 70)
28
(24 to 52.5)
37
(24.5 to 64)
Type of Sickle Cell Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
SS 19 20 39
SC 6 3 9
SB 0 1 1
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
2 3 5
1.Primary Outcome
Title Change in Pain Score 20 Minutes After Administration of Study Drug
Hide Description

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.

Time Frame Baseline and 20 minutes after administration of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 25 24
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1
(0 to 2)
2
(0.5 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intranasal Saline, Intranasal Fentnayl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Presence of Bradycardia
Hide Description Number of participants who had bradycardia
Time Frame Every 5 minutes until 30 minutes after study drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 25 24
Measure Type: Number
Unit of Measure: participants
0 0
3.Secondary Outcome
Title Presence of Headache
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of their ED visit, an expected average of 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants
0 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intranasal Saline, Intranasal Fentnayl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Admission Rate
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 25 24
Measure Type: Number
Unit of Measure: participants
16 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intranasal Saline, Intranasal Fentnayl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Length of Stay in ED
Hide Description Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure
Time Frame Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Total Amount of Narcotics Administered
Hide Description Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure
Time Frame Participants will be followed for the duration of their ED visit, an expected average of 6 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Time to Study Drug Administration
Hide Description [Not Specified]
Time Frame Time from triage to adminstration of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: minutes
47  (28) 43  (36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intranasal Saline, Intranasal Fentnayl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.68
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change in Pain Score at 10 Minutes
Hide Description

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.

Time Frame Baseline and 10 minutes after administration of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 25 24
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(0 to 2)
2
(0 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intranasal Saline, Intranasal Fentnayl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Change in Pain Score at 30 Minutes
Hide Description

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.

Time Frame Baseline and 30 minutes after administration of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 25 24
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(0 to 2)
2
(0 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intranasal Saline, Intranasal Fentnayl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Change in Pain Score
Hide Description Due to confounding factors we were unable to obtain reliable data for this outcome
Time Frame Baseline and immediately prior to IV insertion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Respiratory Distress
Hide Description Participants who had respiratory distress within 30 min of study drug administration
Time Frame Every 5 minutes until 30 minutes after study drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 25 24
Measure Type: Number
Unit of Measure: participants
0 0
12.Secondary Outcome
Title Hypotension
Hide Description Participants who had hypotension within 30 min of study drug administration
Time Frame Every 5 minutes until 30 minutes after study drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 25 24
Measure Type: Number
Unit of Measure: participants
2 2
13.Secondary Outcome
Title Hypoxia
Hide Description Number of participants who had hypoxia within 30 min of study drug adminsitration
Time Frame Every 5 minutes until 30 minutes after study drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 25 24
Measure Type: Number
Unit of Measure: participants
0 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intranasal Saline, Intranasal Fentnayl
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intranasal Saline Intranasal Fentnayl
Hide Arm/Group Description 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. 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
All-Cause Mortality
Intranasal Saline Intranasal Fentnayl
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intranasal Saline Intranasal Fentnayl
Affected / at Risk (%) Affected / at Risk (%)
Total   2/25 (8.00%)   5/24 (20.83%) 
Cardiac disorders     
Hypotension [1]  2/25 (8.00%)  2/24 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia [2]  0/25 (0.00%)  3/24 (12.50%) 
[1]
No subjects received any intervention for the transient hypotension
[2]
No subjects received any intervention for the transient hypoxia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intranasal Saline Intranasal Fentnayl
Affected / at Risk (%) Affected / at Risk (%)
Total   9/25 (36.00%)   12/24 (50.00%) 
Blood and lymphatic system disorders     
Blood Transfusion  0/25 (0.00%)  2/24 (8.33%) 
Gastrointestinal disorders     
Nausea  1/25 (4.00%)  2/24 (8.33%) 
Nervous system disorders     
Sleepiness  6/25 (24.00%)  10/24 (41.67%) 
Headache  0/25 (0.00%)  4/24 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
Acute Chest Syndrome  2/25 (8.00%)  2/24 (8.33%) 
Skin and subcutaneous tissue disorders     
Itching  1/25 (4.00%)  2/24 (8.33%) 
Nasal Pain  0/25 (0.00%)  3/24 (12.50%) 
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
Responsible Party: Daniel Marc Fein, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01482091     History of Changes
Other Study ID Numbers: 11-09-343
First Submitted: November 22, 2011
First Posted: November 30, 2011
Results First Submitted: March 30, 2016
Results First Posted: August 19, 2016
Last Update Posted: August 19, 2016