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

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• Status: Withdrawn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: Traumatic Brain Injury; Computed Tomography; Procedural Sedation
• Intervention / Treatment: Drug: Chloral Hydrate; Drug: Midazolam

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

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

Study record dates

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: Randomized controlled trial; Pediatrics; Midazolam; Deep Sedation; Chloral hydrate; Emergency Hospital Services
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Chloral Hydrate
• Other Study ID Numbers: USP-Sed-001