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

This study is not yet open for participant recruitment.
Verified July 2011 by University of Sao Paulo
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01402596
First received: July 19, 2011
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Computed Tomography
Procedural Sedation
 Drug: Midazolam
Drug: Chloral Hydrate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours ] [ Designated as safety issue: Yes ]
    Such as hypoxemia, respiratory depression, vomiting, hypotension


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 200
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402596

Contacts
Contact: Eduardo Mekitarian Filho, MD, MSc emf2002@uol.com.br

Locations
Brazil
University of Sao Paulo Not yet recruiting
Sao Paulo, SP, Brazil, 05508000
Contact: Eduardo Mekitarian Filho, MD, MSc     551171527710     emf2002@uol.com.br    
Principal Investigator: Eduardo Mekitarian Filho, MD, MSc            
Sub-Investigator: Cassiano Garcia, MD            
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Eduardo Mekitarian Filho, MSc University of Sao Paulo
  More Information

No publications provided

Responsible Party: Eduardo Mekitarian Filho, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01402596     History of Changes
Other Study ID Numbers: USP-Sed-001
Study First Received: July 19, 2011
Last Updated: July 25, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Deep Sedation
Pediatrics
Emergency Hospital Services
 Midazolam
Chloral hydrate
Randomized controlled trial

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Chloral Hydrate
Midazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013