Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

Phase 4

Completed

Conditions: Pain
Anemia, Sickle Cell

Interventions: Drug: Normal Saline
Drug: Fentanyl Citrate

Registration Number: NCT01482091

Lead Sponsor: Montefiore Medical Center

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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 124

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Saline	Normal Saline	-
Intranasal Fentnayl	Fentanyl Citrate	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Score 20 Minutes After Administration of Study Drug	Baseline and 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.

Secondary Outcome Measures

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