Traumatic Brain Injury Clinical Trial
Official title:
Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam - a Randomized Controlled Trial
Thousands of children receive sedation for diagnostic and therapeutic interventions
annually, and this number is expected to increase. Children are at higher risk for
sedation-related complications than adults. In different scenarios, multiple drugs are used
to achieve sedation, each one with particular adverse events that must be monitored and
reported.
Children that need CT scans for traumatic brain injuries often need sedation, without
needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low
incidence of adverse events; however, despite its worldwide use, it's being abandoned due to
bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam,
on the other hand, produces high and fast concentrations on CSF with greater rates of
success but probably with higher adverse events. There are no prospective studies with large
series of patients using intranasal midazolam.
The aim of this study is to determine if nasal midazolam is a safer approach and more
effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT
scans.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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