Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

Pain Clinical Trial

Official title:

Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482091
• Other study ID #: 11-09-343
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2011
• Last updated: December 18, 2015
• Start date: December 2011

Study information

• Verified date: December 2015
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Pain

Intervention

Drug:
• Fentanyl Citrate
A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
• Normal Saline
A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.

Locations

Country	Name	City	State
United States	Children's Hospital at Montefiore	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain score 20 minutes after administration of study drug		Baseline and 20 minutes after administration of study drug	No
Secondary	Heart rate prior to and after the administration of study drug		Every 5 minutes until 30 minutes after study drug administration	Yes
Secondary	Presence of nausea, vomiting, itching and headache		Participants will be followed for the duration of their ED visit, an expected average of 6 hours	Yes
Secondary	Admission rate		This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage	No
Secondary	Length of stay in ED		Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours	No
Secondary	Total amount of narcotics administered		Participants will be followed for the duration of their ED visit, an expected average of 6 hours	No
Secondary	Time to study drug administration		Time from triage to adminstration of study drug, an expected average of 20 minutes	No
Secondary	Change in Pain Score		Baseline and 10 minutes after administration of study drug	No
Secondary	Change in Pain Score		Baseline and 30 minutes after administration of study drug	No
Secondary	change in pain score		Baseline and immediately prior to IV insertion	No
Secondary	Respiratory rate prior to and after the administration of study drug		Every 5 minutes until 30 minutes after study drug administration	Yes
Secondary	Blood Pressure prior to and after the administration of study drug		Every 5 minutes until 30 minutes after study drug administration	Yes
Secondary	Oxygen saturation prior to and after the administration of study drug		Every 5 minutes until 30 minutes after study drug administration	Yes