CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 171 enrolled
Drug / intervention
Intranasal fentanyl +2 moredrug
Likely dose
Intranasal fentanyl 2mcg/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/NCT01244126
NCT01244126Phase 4Completed

Postoperative Analgesic and Behavioral Effects of Intranasal Fentanyl, Intravenous Morphine and Intramuscular Morphine in Pediatric Patients Undergoing Bilateral Myringotomy and Placement of Ventilating Tubes

Baylor College of Medicine·interventional·Posted Nov 19, 2010·Updated Mar 3, 2016

In Brief

A Phase 4 clinical trial evaluating Intranasal fentanyl, morphine IM, and 1 other intervention for Otitis Media. Completed, enrolled 171 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the difference in effect of three clinically common methods of providing pain medication during surgery for ventilating tubes placed for recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in a muscle, and morphine injected in a vein.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 19, 2010
Enrollment StartMay 1, 2008
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.6 years ago

Interventions

Intranasal fentanyldrug

2mcg/kg fentanyl IN

morphine IMdrug

0.1 mg/kg morphine IM for postop pain

IV morphinedrug

0.1 mg/kg morphine IV