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

Phase 2

Withdrawn

• Conditions: Traumatic Brain Injury; Computed Tomography; Procedural Sedation
• Interventions: Drug: Midazolam; Drug: Chloral Hydrate

• Registration Number: NCT01402596
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-07
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2011-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Midazolam	Midazolam	Children undergoing CT scanning will receive in this arm 0,4 mg/kg of nasal midazolam.
Chloral hydrate	Chloral Hydrate	Children undergoing CT scanning will receive in this arm 50 mg per kg of rectal chloral hydrate.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil