Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam
Status:
Withdrawn
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
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.