Pharmacological Action Clinical Trial
— PARADOXOfficial title:
PARADOX - the Incidence of Paradoxical Reactions in Pediatric Patients Premedicated With Midazolam
NCT number | NCT04190537 |
Other study ID # | 273/15 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | June 30, 2020 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Masaryk hospital | Ústí Nad Labem |
Lead Sponsor | Collaborator |
---|---|
Masaryk Hospital Usti nad Labem |
Czechia,
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
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 |
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