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Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging

Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01900405
Enrollment
60
Registered
2013-07-16
Start date
2013-04-30
Completion date
2014-01-31
Last updated
2013-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Traumatic Brain Injury

Keywords

Dexmedetomidine, Administration, Intranasal, Children, Computerized Tomography

Brief summary

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

Detailed 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.

Interventions

DRUGDexmedetomidine

Sponsors

Boston Children's Hospital
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rates of sedation failure with intranasal dexmedetomidine for sedation for pediatric CT imagingFailure 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).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.

Secondary

MeasureTime frameDescription
Safety of IN dexmedetomidine for pediatric CT imagingAt admission and every 5 minutes after sedationPatients 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.

Countries

Brazil

Contacts

Primary ContactEduardo Mekitarian Filho, MD, PhD
emf2002@uol.com.br+55 11 30919333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026