NCT01402596

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 1 Month – 3 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Midazolam	0,4 mg per kg - intranasal midazolam - once
DRUG	Chloral Hydrate	50 mg per kg, rectal

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-07-26
• Last updated: 2013-06-20

Locations

1 site across 1 country: Brazil