CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 749 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in 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/NCT04190537
NCT04190537N/ACompleted

PARADOX - the Incidence of Paradoxical Reactions in Pediatric Patients Premedicated with Midazolam

Masaryk Hospital Usti nad Labem·observational·Posted Dec 9, 2019·Updated Oct 9, 2024

In Brief

An observational study for Pharmacological Action. Completed, enrolled 749 participants across 1 site.

Detailed Summary

Summary The premedication is one of the essential sides of pediatrics anesthesia. Midazolam is considered such as standard these days. Children may develope a paradoxical reaction to benzodiazepines which is one of the adverse effect. Its incidence is unknown. The hypothesis is, in pediatric patients undergoing general anesthesia premedicated with oral midazolam, the incidence of the paradoxical reaction is 10%. Primary Goal of the study is to find out the incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia. Secondary goal is to find out the incidence of the paradoxical reactions in children of different age groups. For the assessment, the study uses parameters: RASS, blood pressure, heart rate, PAED, PSAS, MAS and VAS.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 9, 2019
Enrollment StartSep 1, 2019
Primary CompletionJun 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.6 years ago