CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 418 enrolled
Drug / intervention
Dexmedetomidine +1 moredrug
Likely dose
Dexmedetomidine 0.5 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/NCT01528891
NCT01528891Phase 3Completed
CompareCT.gov

Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children

Peter Davis·interventional·Posted Feb 8, 2012·Updated Mar 8, 2018

In Brief

A Phase 3 clinical trial evaluating Dexmedetomidine and Placebo for Tonsillectomy. Completed, enrolled 418 participants across 2 sites.

Detailed Summary

To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2012
Enrollment StartJan 1, 2012
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.4 years ago

Interventions

Dexmedetomidinedrug

0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery

Placeboother