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.
Brief Title
Intranasal Fentanyl for Initial Treatment of 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
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
Categories
Conditions
Anemia, Sickle Cell
Pain
Eligibility 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
* 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
Inclusion Criteria
Inclusion Criteria:
* Sickle Cell Disease
* Ages 3 years - 21 years
* Sickle Cell Disease
* Ages 3 years - 21 years
Gender
All
Gender Based
false
Keywords
fentanyl
intranasal
sickle cell
vasoocclusive crisis
pain crisis
pediatrics
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
21 Years
Minimum Age
3 Years
NCT Id
NCT01482091
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
11-09-343
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial
Primary Outcomes
Outcome 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.
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.
Outcome Measure
Change in Pain Score 20 Minutes After Administration of Study Drug
Outcome Time Frame
Baseline and 20 minutes after administration of study drug
Secondary Outcomes
Outcome Description
Number of participants who had bradycardia
Outcome Time Frame
Every 5 minutes until 30 minutes after study drug administration
Outcome Measure
Presence of Bradycardia
Outcome Time Frame
Participants will be followed for the duration of their ED visit, an expected average of 6 hours
Outcome Measure
Presence of Headache
Outcome 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
Outcome Measure
Admission Rate
Outcome Description
Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure
Outcome Time Frame
Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours
Outcome Measure
Length of Stay in ED
Outcome Description
Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure
Outcome Time Frame
Participants will be followed for the duration of their ED visit, an expected average of 6 hours
Outcome Measure
Total Amount of Narcotics Administered
Outcome Time Frame
Time from triage to adminstration of study drug
Outcome Measure
Time to Study Drug Administration
Outcome 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.
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.
Outcome Time Frame
Baseline and 10 minutes after administration of study drug
Outcome Measure
Change in Pain Score at 10 Minutes
Outcome 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.
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.
Outcome Time Frame
Baseline and 30 minutes after administration of study drug
Outcome Measure
Change in Pain Score at 30 Minutes
Outcome Description
Due to confounding factors we were unable to obtain reliable data for this outcome
Outcome Time Frame
Baseline and immediately prior to IV insertion
Outcome Measure
Change in Pain Score
Outcome Description
Participants who had respiratory distress within 30 min of study drug administration
Outcome Time Frame
Every 5 minutes until 30 minutes after study drug administration
Outcome Measure
Respiratory Distress
Outcome Description
Participants who had hypotension within 30 min of study drug administration
Outcome Time Frame
Every 5 minutes until 30 minutes after study drug administration
Outcome Measure
Hypotension
Outcome Description
Number of participants who had hypoxia within 30 min of study drug adminsitration
Outcome Time Frame
Every 5 minutes until 30 minutes after study drug administration
Outcome Measure
Hypoxia
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
21
Minimum Age Number (converted to Years and rounded down)
3
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Fein
Investigator Email
dfein@montefiore.org
Investigator Phone
718-320-5312