Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

This study is currently recruiting participants.
Verified March 2013 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
hnin khine, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01482091
First received: November 22, 2011
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Anemia, Sickle Cell
Pain
Drug: Fentanyl Citrate
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Change in pain score 20 minutes after administration of study drug [ Time Frame: Baseline and 20 minutes after administration of study drug ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482091

Contacts
Contact: Daniel M Fein, MD 718-920-5312 dfein@montefiore.org
Contact: Hnin Khine, MD 718-920-5312 hkhine@montefiore.org

Locations
United States, New York
Children's Hospital at Montefiore Recruiting
Bronx, New York, United States, 10467
Sub-Investigator: Daniel M Fein, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Hnin Khine, MD Children's Hospital at Montefiore
Study Director: Daniel M Fein, MD Children's Hospital at Montefiore
  More Information

No publications provided

Responsible Party: hnin khine, Associate Professor of Clinical Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01482091     History of Changes
Other Study ID Numbers: 11-09-343
Study First Received: November 22, 2011
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
fentanyl
intranasal
sickle cell
vasoocclusive crisis
pain crisis
pediatrics

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 16, 2014