Clinical trial NCT01482091: Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
Official title: Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia, Sickle Cell
Pain
Keywords: fentanyl
intranasal
sickle cell
vasoocclusive crisis
pain crisis
pediatrics
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 124
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 crisis.

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 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

Eligibility 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

Primary outcomes:
measure: Change in Pain Score 20 Minutes After Administration of Study Drug
timeFrame: Baseline and 20 minutes after administration of study drug
Secondary outcomes:
measure: Presence of Bradycardia
timeFrame: Every 5 minutes until 30 minutes after study drug administration
measure: Presence of Headache
timeFrame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours
measure: Admission Rate
timeFrame: This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage
measure: Length of Stay in ED
timeFrame: Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours
measure: Total Amount of Narcotics Administered
timeFrame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours
measure: Time to Study Drug Administration
timeFrame: Time from triage to adminstration of study drug
measure: Change in Pain Score at 10 Minutes
timeFrame: Baseline and 10 minutes after administration of study drug
measure: Change in Pain Score at 30 Minutes
timeFrame: Baseline and 30 minutes after administration of study drug
measure: Change in Pain Score
timeFrame: Baseline and immediately prior to IV insertion
measure: Respiratory Distress
timeFrame: Every 5 minutes until 30 minutes after study drug administration
measure: Hypotension
timeFrame: Every 5 minutes until 30 minutes after study drug administration
measure: Hypoxia
timeFrame: Every 5 minutes until 30 minutes after study drug administration
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
Study officials:
affiliation: Children's Hospital at Montefiore
name: Daniel M Fein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital at Montefiore
name: Daniel M Fein, MD
role: STUDY_DIRECTOR
References: