Status:
COMPLETED
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
Lead Sponsor:
Montefiore Medical Center
Conditions:
Anemia, Sickle Cell
Pain
Eligibility:
All Genders
3-21 years
Phase:
PHASE4
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 cris...
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 k...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01482091
Start Date
December 1 2011
Last Update
August 19 2016
Active Locations (1)
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1
Children's Hospital at Montefiore
The Bronx, New York, United States, 10467