- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01900405
Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging
Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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SP
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Sao Paulo, SP, Brasil, 05508000
- Reclutamiento
- University Hospital, University of Sao Paulo
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Contacto:
- Alfredo Gilio, MD, PhD
- Número de teléfono: 919409 +55 11 30919200
- Correo electrónico: aegilio@uol.com.br
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Investigador principal:
- Eduardo Mekitarian Filho, MD, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Children between 1 month to 15 years old undergoing CT scans in the pediatric emergency department
Exclusion Criteria:
- Glasgow coma scale < 13
- Epistaxis or suspected base skull fracture
- Use of contrast or need for an IV line before sedation
- Uncontrolled gastroesophageal reflux or vomiting
- Current (or within past 3 months) history of apnea of prematurity requiring an apnea monitor
- Acute, unstable respiratory disease
- Unstable cardiac status
- Craniofacial anomaly
- Medication use: digoxin
- Moya Moya Disease
- New onset stroke
- American Society of Anesthesiologists physical status ≥3
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Dexmedetomidine
All children undergoing
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Rates of sedation failure with intranasal dexmedetomidine for sedation for pediatric CT imaging
Periodo de tiempo: Failure to sedate will be defined as non-completion of CT imaging after 2 nasal doses of dexmedetomidine (2.5 mcg/kg at admission; 0.5 mcg/kg after 15 minutes if not sedated).
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Main outcome for this research is to know if IN dexmedetomidine is effective for adequate sedation in children undergoing CT scannings.
This will be reported as percentage of failed sedations, if they occur.
Failed sedations will be defined if after a initial 2.5 mcg/kg dose along with another 0.5 mcg/kg dose after 15 minutes, the child does not sedate.
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Failure to sedate will be defined as non-completion of CT imaging after 2 nasal doses of dexmedetomidine (2.5 mcg/kg at admission; 0.5 mcg/kg after 15 minutes if not sedated).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Safety of IN dexmedetomidine for pediatric CT imaging
Periodo de tiempo: At admission and every 5 minutes after sedation
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Patients will be fully monitored every five minutes after IN dexmedetomidine administration, with heart rate, respiratory rate, non-invasive blood pressure and pulse oximetry.
Any adverse events will be reported.
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At admission and every 5 minutes after sedation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Keira Mason, MD, Boston Children's Hospital, Harvard Medical School
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Lesiones Cerebrales
- Lesiones Cerebrales Traumáticas
- Efectos fisiológicos de las drogas
- Agentes adrenérgicos
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Analgésicos no narcóticos
- Agonistas del receptor adrenérgico alfa-2
- Agonistas alfa adrenérgicos
- Agonistas adrenérgicos
- Hipnóticos y sedantes
- Dexmedetomidina
Otros números de identificación del estudio
- USPDex
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