CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 101 enrolled
Drug / intervention
Saline +3 moredrug
Likely dose
Fentanyl 2 microgramsfrom 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/NCT00654329
NCT00654329Phase 4Completed
CompareCT.gov

Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)

Children's National Research Institute·interventional·Posted Apr 8, 2008·Updated Apr 25, 2011

In Brief

A Phase 4 clinical trial evaluating Saline, Fentanyl, and 1 other intervention for Otitis. Completed, enrolled 101 participants across 1 site.

Detailed Summary

A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis
CountriesUnited States
CollaboratorsHospira, now a wholly owned subsidiary of Pfizer

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 8, 2008
Enrollment StartAug 1, 2005
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.2 years ago

Interventions

Salinedrug

Normal saline, given intranasally

Fentanyldrug

Fentanyl, nasal transmucosal, 2 micrograms/kilogram

Dexmedetomidinedrug

Dexmedetomidine, transmucosal, 1 microgram/kilogram

Dexmedetomidinedrug

Dexmedetomidine, 2 microgram/kilogram, transmucosal route