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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Saline | Placebo Comparator |
| |
| Intranasal Fentnayl | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Citrate | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria for Enrollment:
Exclusion Criteria at presentation in ED with a painful crisis:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel M Fein, MD | Children's Hospital at Montefiore | Principal Investigator |
| Daniel M Fein, MD | Children's Hospital at Montefiore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intranasal Fentnayl |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 20 minutes after administration of study drug |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | No subjects received any intervention for the transient hypoxia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleepiness | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Fein | Albert Einstein College of Medicine/Children's Hospital at Montefiore | 718-920-5312 | dfein@montefiore.org |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D010146 | Pain |
| D000098644 | Vaso-Occlusive Crises |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
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| Normal Saline | Drug | 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. |
|
| 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 |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| weight | Median | Inter-Quartile Range | kg |
|
| Type of Sickle Cell Disease | 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 | Number | participants |
|
| Duration of VOC | Number | participants |
|
| Location of VOC | Number | participants |
|
| Oral analgesic within 2h prior to study drug | Number | participants |
|
| OG000 | 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. |
| OG001 | 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 |
|
|
|
| Secondary | Presence of Bradycardia | Number of participants who had bradycardia | Posted | Number | participants | Every 5 minutes until 30 minutes after study drug administration |
|
|
|
| Secondary | Presence of Headache | Posted | Number | participants | Participants will be followed for the duration of their ED visit, an expected average of 6 hours |
|
|
|
|
| Secondary | Admission Rate | Posted | Number | participants | This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage |
|
|
|
|
| Secondary | Length of Stay in ED | Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure | Posted | Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours |
|
|
| Secondary | Total Amount of Narcotics Administered | Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure | Posted | Participants will be followed for the duration of their ED visit, an expected average of 6 hours |
|
|
| Secondary | Time to Study Drug Administration | Posted | Mean | Standard Deviation | minutes | Time from triage to adminstration of study drug |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 10 minutes after administration of study drug |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 30 minutes after administration of study drug |
|
|
|
|
| Secondary | Change in Pain Score | Due to confounding factors we were unable to obtain reliable data for this outcome | Posted | Baseline and immediately prior to IV insertion |
|
|
| Secondary | Respiratory Distress | Participants who had respiratory distress within 30 min of study drug administration | Posted | Number | participants | Every 5 minutes until 30 minutes after study drug administration |
|
|
|
| Secondary | Hypotension | Participants who had hypotension within 30 min of study drug administration | Posted | Number | participants | Every 5 minutes until 30 minutes after study drug administration |
|
|
|
| Secondary | Hypoxia | Number of participants who had hypoxia within 30 min of study drug adminsitration | Posted | Number | participants | Every 5 minutes until 30 minutes after study drug administration |
|
|
|
|
| 2 |
| 25 |
| 9 |
| 25 |
| EG001 | 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 | 5 | 24 | 12 | 24 |
|
| Hypotension | Cardiac disorders | No subjects received any intervention for the transient hypotension |
|
| Headache | Nervous system disorders |
|
| Itching | Skin and subcutaneous tissue disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Nasal Pain | Skin and subcutaneous tissue disorders |
|
| Acute Chest Syndrome | Respiratory, thoracic and mediastinal disorders |
|
| Blood Transfusion | Blood and lymphatic system disorders |
|
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |