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

NCT01402596 | Withdrawn Phase 2

• 1 other identifier: USP-Sed-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Computed Tomography; Procedural Sedation

Keywords

Deep Sedation; Pediatrics; Emergency Hospital Services; Midazolam; Chloral hydrate; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of both drugs

  Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours

Study Arms (2)

Chloral hydrate

ACTIVE COMPARATOR

Children undergoing CT scanning will receive in this arm 50 mg per kg of rectal chloral hydrate.

Drug: Chloral Hydrate

Midazolam

ACTIVE COMPARATOR

Children undergoing CT scanning will receive in this arm 0,4 mg/kg of nasal midazolam.

Drug: Midazolam

Interventions

Midazolam DRUG

0,4 mg per kg - intranasal midazolam - once

Midazolam

Chloral Hydrate DRUG

50 mg per kg, rectal

Chloral hydrate

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children undergoing CT scanning for TBI

You may not qualify if:

• epistaxis
• suspected or confirmed skull or nasal fracture
• Moderate to severe traumatic brain injury
• hemodynamically unstable

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508000, Brazil

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Emergencies

Interventions

Midazolam; Chloral Hydrate

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Eduardo Mekitarian Filho, MSc

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 26, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 20, 2013

Record last verified: 2011-07

Locations

BR (1)