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

NCT04190537 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 749

Last updated 2024-10-09

No results posted yet for this study

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.

Conditions

  • Pharmacological Action

Sponsors & Collaborators

  • Masaryk Hospital Usti nad Labem

    lead OTHER

Principal Investigators

  • Petr Vojtisek, doctor · Masaryk Hospital Usti nad Labem

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-06-16
Completion
2021-06-16

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190537 on ClinicalTrials.gov