CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 124 enrolled
Drug / intervention
Fentanyl Citrate +1 moredrug
Likely dose
Fentanyl Citrate 2 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01482091
NCT01482091Phase 4Completed
CompareCT.gov

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

Montefiore Medical Center·interventional·Posted Nov 30, 2011·Updated Aug 19, 2016

In Brief

A Phase 4 clinical trial evaluating Fentanyl Citrate and Normal Saline for Anemia, Sickle Cell and Pain. Completed, enrolled 124 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Sickle Cell, Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2011
Enrollment StartDec 1, 2011
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.6 years ago

Interventions

Fentanyl Citratedrug

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 Salinedrug

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.