CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Midazolam +1 moredrug
Likely dose
Midazolam 15mgfrom 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/NCT03806270
NCT03806270N/ACompleted

Hydroxyzine Dihydrochloride Premedication is a Necessity for Pediatric Patients Undergoing Strabismus Surgery; An Observational Clinical Trial Controlled With Midazolam

Yeditepe University·observational·Posted Jan 16, 2019·Updated Oct 22, 2019

In Brief

An observational study evaluating Midazolam and Hydroxyzine Dihydrochloride for Strabismus and 3 related conditions. Completed, enrolled 45 participants across 2 sites.

Detailed Summary

Oculocardiac reflex (OCR) is usually happening in pediatric strabismus surgery and observed just when the surgent pulls the ocular muscles. The reflex is one of the trigemino-vagal reflexes, and causes bradycardia, arrhythmia, and even cardiac arrest during eye surgery. Premedication for relaxation with drugs like hydroxyzine dihydrochloride or midazolam before surgery of the pediatric population is often used in Turkey, although it is not recommended in foreign countries. Some recent studies showed that when midazolam and hydroxyzine dihydrochloride used together not only, they lessen agitation before surgery but also they prevent emergence agitation. The primary aim of this prospective observational study is to show the effect of hydroxyzine dihydrochloride on preventing the pediatric patient from Oculocardiac reflex related to strabismus surgery.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 16, 2019
Enrollment StartOct 1, 2018
Primary CompletionFeb 15, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.5 years ago

Interventions

Midazolamdrug

Demizolam 15mg/ml ampules, given orally with cherry juice

Hydroxyzine Dihydrochloridedrug

Atarax 2mg/ml syrup, given orally