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

June 19, 2013 updated by: University of Sao Paulo

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05508000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Director: Eduardo Mekitarian Filho, MSc, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP-Sed-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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