Pharmacological Action Clinical Trial
Official title:
PARADOX - the Incidence of Paradoxical Reactions in Pediatric Patients Premedicated With Midazolam
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.
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.
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