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Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

NCT01482091 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2016-08-19

Study results available
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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

Interventions

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

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.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Daniel M Fein, MD · Children's Hospital at Montefiore

  • Daniel M Fein, MD · Children's Hospital at Montefiore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01482091 on ClinicalTrials.gov