Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Anemia, Sickle Cell; Pain

Treatments: Drug: Normal Saline; Drug: Fentanyl Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01482091

11-09-343

Details and patient eligibility

About

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.

Full 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

Enrollment: 124 patients

Sex: All

Ages: 3 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

Intranasal Saline

Placebo Comparator group

Treatment:

Drug: Normal Saline

Intranasal Fentnayl

Experimental group

Treatment:

Drug: Fentanyl Citrate