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

Sponsor

University of Sao Paulo (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01402596

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Computed Tomography Procedural Sedation	Drug: Midazolam Drug: Chloral Hydrate	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2011

Anticipated Primary Completion Date :

Aug 1, 2012

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Midazolam 0,4 mg per kg - intranasal midazolam - once

Arm

Intervention/Treatment

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.

Drug: Midazolam

0,4 mg per kg - intranasal midazolam - once

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.