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

Sponsored by Masaryk Hospital Usti nad Labem

About this trial

Last updated 6 years ago

Study ID

273/15

Status

Unknown status

Type

Observational

Placebo

No

Accepting

18-75 Years
3 to 18 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- oral midazolam premedication for at least 30 minutes before rating

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

No

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

Locations

Location

Status

Recruiting