Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

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.

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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

Conditions

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Anemia, Sickle Cell Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intranasal Saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type 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.

Intranasal Fentnayl

Group Type EXPERIMENTAL

Fentanyl Citrate

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Sickle Cell Disease
* Ages 3 years - 21 years

Exclusion Criteria

* Pregnancy
* Known allergy to Fentanyl
* Usage of daily home opiates

* 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

Minimum Eligible Age

3 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No