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

NCT04190537 | Completed

• 1 other identifier: 273/15
• Study Type: observational
• Target: 749
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacological Action

Keywords

Paradoxial reaction midazolam

Outcome Measures

Primary Outcomes (1)

• Incidence of the paradoxical reaction in pediatric patients premedicated with oral midazolam prior to general anesthesia.

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

  Change within 45min. after premedication

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Masaryk Hospital Usti nad Labem: lead

Study Sites (1)

Masaryk hospital

Ústí nad Labem, 40011, Czechia

Location

Related Publications (4)

• Moon YE. Paradoxical reaction to midazolam in children. Korean J Anesthesiol. 2013 Jul;65(1):2-3. doi: 10.4097/kjae.2013.65.1.2. No abstract available.

  PMID: 23904931 BACKGROUND

• Shin YH, Kim MH, Lee JJ, Choi SJ, Gwak MS, Lee AR, Park MN, Joo HS, Choi JH. The effect of midazolam dose and age on the paradoxical midazolam reaction in Korean pediatric patients. Korean J Anesthesiol. 2013 Jul;65(1):9-13. doi: 10.4097/kjae.2013.65.1.9. Epub 2013 Jul 19.

  PMID: 23904933 BACKGROUND

• Tobin JR. Paradoxical effects of midazolam in the very young. Anesthesiology. 2008 Jan;108(1):6-7. doi: 10.1097/01.anes.0000296717.85521.b5. No abstract available.

  PMID: 18156876 BACKGROUND

• McKenzie WS, Rosenberg M. Paradoxical reaction following administration of a benzodiazepine. J Oral Maxillofac Surg. 2010 Dec;68(12):3034-6. doi: 10.1016/j.joms.2010.06.176. Epub 2010 Oct 14. No abstract available.

  PMID: 20950912 BACKGROUND

Study Officials

• Petr Vojtisek, doctor

  Masaryk Hospital Usti nad Labem

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Petr Vojtisek, senior consultant of paediatric anesthesia and IC

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: September 1, 2019
• Primary Completion: June 16, 2021
• Study Completion: June 16, 2021
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)