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

Pharmacological Action Clinical Trial

— PARADOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190537
• Other study ID #: 273/15
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2019
• Source: Masaryk Hospital Usti nad Labem
• Contact: Petr Vojtisek, doctor
• Phone: +420605572106
• Email: petr.vojtisek[@]kzcr.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacological Action

Locations

Country	Name	City	State
Czechia	Masaryk hospital	Ústí Nad Labem

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk Hospital Usti nad Labem

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Tobin JR. Paradoxical effects of midazolam in the very young. Anesthesiology. 2008 Jan;108(1):6-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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