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- Essai clinique NCT01900405
Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging
Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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SP
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Sao Paulo, SP, Brésil, 05508000
- Recrutement
- University Hospital, University of Sao Paulo
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Contact:
- Alfredo Gilio, MD, PhD
- Numéro de téléphone: 919409 +55 11 30919200
- E-mail: aegilio@uol.com.br
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Chercheur principal:
- Eduardo Mekitarian Filho, MD, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Dexmedetomidine
All children undergoing
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rates of sedation failure with intranasal dexmedetomidine for sedation for pediatric CT imaging
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Safety of IN dexmedetomidine for pediatric CT imaging
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Keira Mason, MD, Boston Children's Hospital, Harvard Medical School
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Blessures et Blessures
- Traumatisme crânio-cérébral
- Traumatisme, système nerveux
- Lésions cérébrales
- Lésions cérébrales, traumatiques
- Effets physiologiques des médicaments
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Analgésiques, non narcotiques
- Agonistes des récepteurs adrénergiques alpha-2
- Alpha-agonistes adrénergiques
- Agonistes adrénergiques
- Hypnotiques et sédatifs
- Dexmédétomidine
Autres numéros d'identification d'étude
- USPDex
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