Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

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

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

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 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.

This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage

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

Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure

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.

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.

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