Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anemia, Sickle Cell
• Intervention / Treatment: Drug: Normal Saline; Drug: Fentanyl Citrate

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

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Children's Hospital at Montefiore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Intranasal Saline	Drug: 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.
Experimental: Intranasal Fentnayl	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Score 20 Minutes After Administration of Study Drug	Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively. To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points.	Baseline and 20 minutes after administration of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Bradycardia	Number of participants who had bradycardia	Every 5 minutes until 30 minutes after study drug administration
Presence of Headache		Participants will be followed for the duration of their ED visit, an expected average of 6 hours
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
Length of Stay in ED	Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure	Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours
Total Amount of Narcotics Administered	Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure	Participants will be followed for the duration of their ED visit, an expected average of 6 hours
Time to Study Drug Administration		Time from triage to adminstration of study drug
Change in Pain Score at 10 Minutes	Change in pain score between 0 and 10 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively. To calculate the change, the reported pain score at 10 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 10 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 10 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 10 minutes) representing a INCREASE in pain between the two time points.	Baseline and 10 minutes after administration of study drug
Change in Pain Score at 30 Minutes	Change in pain score between 0 and 30 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score, which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively. To calculate the change, the reported pain score at 30 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 30 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 30 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 30 minutes) representing a INCREASE in pain between the two time points.	Baseline and 30 minutes after administration of study drug
Change in Pain Score	Due to confounding factors we were unable to obtain reliable data for this outcome	Baseline and immediately prior to IV insertion
Respiratory Distress	Participants who had respiratory distress within 30 min of study drug administration	Every 5 minutes until 30 minutes after study drug administration
Hypotension	Participants who had hypotension within 30 min of study drug administration	Every 5 minutes until 30 minutes after study drug administration
Hypoxia	Number of participants who had hypoxia within 30 min of study drug adminsitration	Every 5 minutes until 30 minutes after study drug administration

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Daniel M Fein, MD, Children's Hospital at Montefiore; Study Director: Daniel M Fein, MD, Children's Hospital at Montefiore

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): November 30, 2011

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: pediatrics; intranasal; fentanyl; sickle cell; vasoocclusive crisis; pain crisis
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 11-09-343

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No