Traumatic Brain Injury, Computed Tomography, Procedural Sedation
Conditions
Keywords
Deep Sedation, Pediatrics, Emergency Hospital Services, Midazolam, Chloral hydrate, Randomized controlled trial
Brief 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.
Interventions
DRUGMidazolam
0,4 mg per kg - intranasal midazolam - once
DRUGChloral Hydrate
50 mg per kg, rectal
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
No
Inclusion criteria
* children undergoing CT scanning for TBI
Exclusion criteria
* epistaxis * suspected or confirmed skull or nasal fracture * Moderate to severe traumatic brain injury * hemodynamically unstable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours | Such as hypoxemia, respiratory depression, vomiting, hypotension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of both drugs | Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours | Patients vital signs and adverse events will be monitored through patient stay in the emergency department. Mean time after sedation is about three hours. Variables collected include Ramsay score for sedation. To consider hospital discharge, we will try to validate Aldrette score and compare the scores between the two arms. Mean time to onset of sedation and time of emergency department stay will also be compared as a mark of efficacy of these two drugs. |
Countries
Brazil
Outcome results
None listed