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

December 10, 2019 updated by: Petr Vojtisek, Masaryk Hospital Usti nad Labem

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 Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All eligible patients should be evaluated for pre-treatment, pre-anesthesia, immediately prior to anesthesia and anesthesia when RASS above -2

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia.
Time Frame: Change within 45min. after premedication
Investigate the incidence of paradoxical reactions after administration of midazolam in the pediatric population
Change within 45min. after premedication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk Hospital Usti nad Labem

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 273/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pharmacological Action

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe