CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Diphenhydramine +4 moredrug
Likely dose
Ketamine 0,1 mg/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/NCT02463929
NCT02463929Phase 4Completed

Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric

Universitas Diponegoro·interventional·Posted Jun 4, 2015·Updated Jun 4, 2015

In Brief

A Phase 4 clinical trial evaluating Diphenhydramine, normal saline, and 3 other interventions for Specified Sedative and Hypnotic. Completed, enrolled 50 participants.

Detailed Summary

The purpose of this study is to investigate the effect of diphenhydramine on the prevention of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/ agitation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 4, 2015
Enrollment StartApr 1, 2014
Primary CompletionJun 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.1 years ago

Interventions

Diphenhydraminedrug

Intravenous Injection

normal salinedrug

Intravenous Injection

Ketaminedrug

Ketamine 0,1 mg/kg intravenously used as rescue tranquilizer if the subject becomes agitated, repeated dose of 0,05 mg/kg every minute can be given if the agitation does not resolve, maximum ketamine dose for tranquilizer 0,25 mg/kg to prevent deep sedation

Sevofluranedrug

Sevoflurane as single sedation agent for general anesthesia in both arm. 8% Sevoflurane in 100% oxygen used as induction agent, and 2% sevoflurane in 50% oxygen used as maintenance agent

Bupivacainedrug

Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.