Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Pediatric Procedural Sedation With Rectal Chloral Hydrate or Intranasal Midazolam - a Randomized Controlled Trial

Conditions
-----------------
Traumatic Brain Injury, Computed Tomography, Procedural Sedation

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: Chloral Hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 3 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chloral hydrate<br>Children undergoing CT scanning will receive in this arm 50 mg per kg of rectal chloral hydrate. | Drug: Chloral Hydrate<br>* 50 mg per kg, rectal<br>|
| Active Comparator: Midazolam<br>Children undergoing CT scanning will receive in this arm 0,4 mg/kg of nasal midazolam. | Drug: Midazolam<br>* 0,4 mg per kg - intranasal midazolam - once<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Such as hypoxemia, respiratory depression, vomiting, hypotension | Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of both drugs | 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. | Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Sedation, Pediatrics, Emergency Hospital Services, Midazolam, Chloral hydrate, Randomized controlled trial