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

Sponsor
Masaryk Hospital Usti nad Labem (Other)
Overall Status
Unknown status
CT.gov ID
NCT04190537
Collaborator
(none)
500
Enrollment
1
Location
10
Anticipated Duration (Months)
50.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    The paradoxical reaction is an abnormal stimulative reaction to benzodiazepines characterized by hallucination, disorientation, alteration in perception and recognition as well as the escalation of negative emotion- uncalming crying, agitation, restlessness, and hostility. Risk factors for the development of the paradoxical reaction are young age, mental illness, genetic disposition, male sex, alcohol abuse, and higher midazolam doses.

    The incidence of paradoxical reaction is referred to be about 1-10%, in some specific groups even more (about 29%). The exact incidence is still not known since the accurate definition of paradoxical reaction is still missing.

    Primary Goal of the study is find out the incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia and incidence of the paradoxical reactions in children of different age groups (3 months-1 year, 1 year-3 years, 3 years-6 years, 6 years-12 years, 12 years-18 years) . The calculated file size is 500 patients. All eligible patients should be evaluated for pre-treatment, pre-anesthesia, immediately prior to anesthesia and anesthesia when RASS above -2. For purpose of the study we have determined the definition of paradoxical reaction as an increase in pulse and/or blood pressure of 20% over pre-premedication , RASS increase by one point or more and raising PEAD to 10 or more points. The paradoxical reaction criteria are met if at least two points of the definition are met. Change within 45min. after premedication.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    PARADOX - the Incidence of Paradoxical Reactions in Pediatric Patients Premedicated With Midazolam
    Actual Study Start Date :
    Sep 1, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2019
    Anticipated Study Completion Date :
    Jun 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia. [Change within 45min. after premedication]

      Investigate the incidence of paradoxical reactions after administration of midazolam in the pediatric population

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    age from 3 months to 18 years

    • oral midazolam premedication for at least 30 minutes before rating

    • patient undergoing deep sedation / general anesthesia diagnostic or surgery with RASS -4 or more

    Exclusion Criteria:

    • personal history of benzodiazepines using

    • moderate or severe respiratory insufficiency

    • myopathy, neuromuscular transmission disorders

    • moderate or severe CNS disability, including brain tumors, uncontrolled convulsions

    • age <3 months and> 18 years

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Masaryk hospital Ústí Nad Labem Czechia 40011

    Sponsors and Collaborators

    • Masaryk Hospital Usti nad Labem

    Investigators

    • Study Chair: Petr Vojtisek, doctor, Masaryk Hospital Usti nad Labem

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Petr Vojtisek, Petr Vojtisek, senior consultant of paediatric anesthesia and IC, Masaryk Hospital Usti nad Labem
    ClinicalTrials.gov Identifier:
    NCT04190537
    Other Study ID Numbers:
    • 273/15
    First Posted:
    Dec 9, 2019
    Last Update Posted:
    Dec 12, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Petr Vojtisek, Petr Vojtisek, senior consultant of paediatric anesthesia and IC, Masaryk Hospital Usti nad Labem
    Paradoxial reaction midazolam

    Study Results

    No Results Posted as of Dec 12, 2019