Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam
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.
|Traumatic Brain Injury Computed Tomography Procedural Sedation||Drug: Midazolam Drug: Chloral Hydrate||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam - a Randomized Controlled Trial|
- Adverse Events [ Time Frame: 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
- Efficacy of both drugs [ Time Frame: 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.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Chloral hydrate
Children undergoing CT scanning will receive in this arm 50 mg per kg of rectal chloral hydrate.
Drug: Chloral Hydrate
50 mg per kg, rectal
Active Comparator: Midazolam
Children undergoing CT scanning will receive in this arm 0,4 mg/kg of nasal midazolam.
0,4 mg per kg - intranasal midazolam - once
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402596
|University of Sao Paulo|
|Sao Paulo, SP, Brazil, 05508000|
|Study Director:||Eduardo Mekitarian Filho, MSc||University of Sao Paulo|