Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

Completed · Phase 4

Conditions studied: Anemia, Sickle Cell, Pain

In brief

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.

Key facts

Study ID

NCT01482091

Run by

Montefiore Medical Center

People needed

124

Starts

2011-12-01

Last updated by the study team

2016-08-19

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Children's Hospital at Montefiore — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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