Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

Study Overview
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Brief Summary
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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
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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

Official Title
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Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial

Conditions
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Anemia, Sickle Cell, Pain

Intervention / Treatment
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* Drug: Fentanyl Citrate
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Intranasal Saline<br> | Drug: Normal Saline<br>* 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.<br>|
| Experimental: Intranasal Fentnayl<br> | Drug: Fentanyl Citrate<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Score 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. | Baseline and 20 minutes after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Bradycardia | Number of participants who had bradycardia | Every 5 minutes until 30 minutes after study drug administration | 
| Presence of Headache |  | Participants will be followed for the duration of their ED visit, an expected average of 6 hours | 
| Admission Rate |  | 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 | Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure | 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 | Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure | Participants will be followed for the duration of their ED visit, an expected average of 6 hours | 
| Time to Study Drug Administration |  | Time from triage to adminstration of study drug | 
| Change in Pain Score at 10 Minutes | 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. | Baseline and 10 minutes after administration of study drug | 
| Change in Pain Score at 30 Minutes | 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. | Baseline and 30 minutes after administration of study drug | 
| Change in Pain Score | Due to confounding factors we were unable to obtain reliable data for this outcome | Baseline and immediately prior to IV insertion | 
| Respiratory Distress | Participants who had respiratory distress within 30 min of study drug administration | Every 5 minutes until 30 minutes after study drug administration | 
| Hypotension | Participants who had hypotension within 30 min of study drug administration | Every 5 minutes until 30 minutes after study drug administration | 
| Hypoxia | Number of participants who had hypoxia within 30 min of study drug adminsitration | Every 5 minutes until 30 minutes after study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fentanyl, intranasal, sickle cell, vasoocclusive crisis, pain crisis, pediatrics