Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Anemia |
| Therapuetic Areas: | Hematology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 3 - 21 |
| Updated: | 4/21/2016 |
| Start Date: | December 2011 |
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial
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.
patients with sickle cell disease who present to the pediatric emergency department with a
vaso-occlusive crisis.
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
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
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
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