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
3 to 18 Years
All
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?
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
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