Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

NCT01482091 | Completed Phase 4 Results DMC

• 1 other identifier: 11-09-343
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Sickle Cell; Pain

Keywords

fentanyl; intranasal; sickle cell; vasoocclusive crisis; pain crisis; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Presence of 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

  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

  Participants will be followed for the duration of their ED visit, an expected average of 6 hours

Study Arms (2)

Intranasal Saline

PLACEBO COMPARATOR

Drug: Normal Saline

Intranasal Fentnayl

EXPERIMENTAL

Drug: Fentanyl Citrate

Interventions

Fentanyl Citrate DRUG

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

Intranasal Fentnayl

Normal Saline DRUG

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.

Intranasal Saline

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Sickle Cell Disease
• Ages 3 years - 21 years

You may not qualify if:

• Pregnancy
• Known allergy to Fentanyl
• Usage of daily home opiates
• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain; Vaso-Occlusive Crises

Interventions

Fentanyl; Saline Solution

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Daniel Fein
• Organization: Albert Einstein College of Medicine/Children's Hospital at Montefiore

dfein@montefiore.org

718-920-5312

Study Officials

• Daniel M Fein, MD

  Children's Hospital at Montefiore

  PRINCIPAL INVESTIGATOR

• Daniel M Fein, MD

  Children's Hospital at Montefiore

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 30, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2015
• Last Updated: August 19, 2016
• Results First Posted: August 19, 2016

Record last verified: 2016-07

Locations

US (1)