A Phase 4 interventional study of Fentanyl Citrate and Normal Saline in Anemia, Sickle Cell and Pain, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2016-08-19.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
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
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 124 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria for Enrollment:
Exclusion Criteria at presentation in ED with a painful crisis:
Drug: Normal Saline
Drug: 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
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.
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.
Time frame: Baseline and 20 minutes after administration of study drug
Presence of Bradycardia
Number of participants who had bradycardia
Time frame: Every 5 minutes until 30 minutes after study drug administration
Presence of Headache
Time frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours
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
Length of Stay in ED
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
Total Amount of Narcotics Administered
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
Time to Study Drug Administration
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline and immediately prior to IV insertion
Respiratory Distress
Participants who had respiratory distress within 30 min of study drug administration
Time frame: Every 5 minutes until 30 minutes after study drug administration
Hypotension
Participants who had hypotension within 30 min of study drug administration
Time frame: Every 5 minutes until 30 minutes after study drug administration
Hypoxia
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
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
| Milestone | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Started | 25 | 24 |
| Completed | 25 | 24 |
| Not completed | 0 | 0 |
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.
| units on a scale | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Change in Pain Score 20 Minutes After Administration of Study Drug | 1 (0 to 2) | 2 (0.5 to 4) |
Number of participants who had bradycardia
| participants | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Presence of Bradycardia | 0 | 0 |
| participants | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Presence of Headache | 0 | 4 |
| participants | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Admission Rate | 16 | 13 |
Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure
No measurements were reported for this outcome.
Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure
No measurements were reported for this outcome.
| minutes | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Time to Study Drug Administration | 47 ± 28 | 43 ± 36 |
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.
| units on a scale | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Change in Pain Score at 10 Minutes | 0 (0 to 2) | 2 (0 to 4) |
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.
| units on a scale | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Change in Pain Score at 30 Minutes | 2 (0 to 2) | 2 (0 to 4) |
Due to confounding factors we were unable to obtain reliable data for this outcome
No measurements were reported for this outcome.
Participants who had respiratory distress within 30 min of study drug administration
| participants | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Respiratory Distress | 0 | 0 |
Participants who had hypotension within 30 min of study drug administration
| participants | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Hypotension | 2 | 2 |
Number of participants who had hypoxia within 30 min of study drug adminsitration
| participants | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| Hypoxia | 0 | 3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intranasal Saline | — | 2/25 (8%) | 9/25 (36%) |
| Intranasal Fentnayl | — | 5/24 (20.8%) | 12/24 (50%) |
| Event | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/25 | 3/24 |
| HypotensionCardiac disorders | 2/25 | 2/24 |
| Event | Intranasal Saline | Intranasal Fentnayl |
|---|---|---|
| SleepinessNervous system disorders | 6/25 | 10/24 |
| HeadacheNervous system disorders | 0/25 | 4/24 |
| Nasal PainSkin and subcutaneous tissue disorders | 0/25 | 3/24 |
| ItchingSkin and subcutaneous tissue disorders | 1/25 | 2/24 |
| NauseaGastrointestinal disorders | 1/25 | 2/24 |
| Acute Chest SyndromeRespiratory, thoracic and mediastinal disorders | 2/25 | 2/24 |
| Blood TransfusionBlood and lymphatic system disorders | 0/25 | 2/24 |
| Age, Continuous(years) | Intranasal Saline | Intranasal Fentnayl | Total |
|---|---|---|---|
| Mean | 12.5 ± 5.1 | 10.6 ± 5.3 | 11.6 ± 5.2 |
| Sex: Female, Male(Participants) | Intranasal Saline | Intranasal Fentnayl | Total |
|---|---|---|---|
| Female | 6 | 13 | 19 |
| Male | 19 | 11 | 30 |
| weight(kg) | Intranasal Saline | Intranasal Fentnayl | Total |
|---|---|---|---|
| Median | 45 (29 to 70) | 28 (24 to 52.5) | 37 (24.5 to 64) |
| Type of Sickle Cell Disease(participants) | Intranasal Saline | Intranasal Fentnayl | Total |
|---|---|---|---|
| SS | 19 | 20 | 39 |
| SC | 6 | 3 | 9 |
| SB | 0 | 1 | 1 |
| Duration of VOC(participants) | Intranasal Saline | Intranasal Fentnayl | Total |
|---|---|---|---|
| <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(participants) | Intranasal Saline | Intranasal Fentnayl | Total |
|---|---|---|---|
| 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(participants) | Intranasal Saline | Intranasal Fentnayl | Total |
|---|---|---|---|
| Number | 2 | 3 | 5 |
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Montefiore Medical Center