Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging

Traumatic Brain Injury Clinical Trial

Official title: Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging

Status Recruiting

Clinical Trial Summary

This study has the objective to determine if intranasal dexmedetomidine, a sedative, is suitable for pediatric sedation in children undergoing tomographic scans.

Clinical Trial Description

Invasive procedures for diagnosis in children are a routine part of an emergency care department. Most of these procedures are painful and uncomfortable for both the child and for their families, and impossible to be performed without patient immobilization. Thus, procedural sedation is critical to this end. Procedural sedation can be defined as the use of sedatives, analgesics, or dissociative drugs for anxiolysis, analgesia, sedation and motor control during painful procedures.

The increasing demand of pediatric emergency services and, consequently, the performance of procedures that require sedation, made it impossible for universal coverage of anesthesiologists in such procedures. As a result, a wide variety of drugs, sedation techniques and different degrees of effectiveness and adverse effects of sedation, such as irritability and sedation failure are described.

Particularly in children who need CT scan, there is usually no need for venous access for sedation. However, our most used drug, chloral hydrate, was abandoned in most centers outside the country. When administered orally, the drug produces malaise and vomiting, and gastric mucosal irritation, in addition, the rectal absorption is unpredictable. Additionally, in recent years increasing importance has been given to the fact that the drug be related, in vitro, the increased carcinogenicity in mice by cellular structural change, which is leading to the ban of same drug in the United States and in some european countries.

Dexmedetomidine is a highly selective alpha-2 agonist receptors, which has the advantage of mimicking natural sleep, according to electroencephalographic studies, with low incidence of adverse events. Its application as a sedative in pediatric procedures, as well as pre-anesthetic medication, has been increasingly described according to recent studies. The intranasal route has been used with the advantage of avoiding a venous line or intramuscular injection, with good results; however, it hasn't been described yet in children undergoing CT scans.

Thus, this work is justified to describe, in a pioneering way, the use of intranasal dexmedetomidine for sedation for CT, documenting its efficacy and safety in a specific cohort of patients sedated for this purpose. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Children
• Traumatic Brain Injury

• NCT number: NCT01900405
• Study type: Observational
• Source: University of Sao Paulo
• Contact: Eduardo Mekitarian Filho, MD, PhD
• Phone: +55 11 30919333
• Email: emf2002@uol.com.br
• Status: Recruiting
• Phase: N/A
• Start date: April 2013
• Completion date: January 2014