Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging

NCT01900405 | Unknown

• 1 other identifier: USPDex
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Traumatic Brain Injury; Children

Keywords

Dexmedetomidine; Administration, Intranasal; Children; Computerized Tomography

Outcome Measures

Primary Outcomes (1)

• Rates of sedation failure with intranasal dexmedetomidine for sedation for pediatric CT imaging

  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.

  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).

Secondary Outcomes (1)

• Safety of IN dexmedetomidine for pediatric CT imaging

  At admission and every 5 minutes after sedation

Study Arms (1)

Dexmedetomidine

All children undergoing

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Also known as: Precedex (brand name)

Dexmedetomidine

Eligibility Criteria

• Age: 1 Month - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The University Hospital of University of Sao Paulo is a secondary teaching hospital. The Pediatric Emergency Department has over 6,000 consultations per month, mainly in children without underlying diseases. Respiratory diseases are the leading causes of hospital admission. During the study period, any children presented to the emergency department with indication for a CT scanning will be recruited for IN dexmedetomidine, respecting the exclusion criteria displayed below.

You may qualify if:

• Children between 1 month to 15 years old undergoing CT scans in the pediatric emergency department

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

University Hospital, University of Sao Paulo

São Paulo, São Paulo, 05508000, Brazil

RECRUITING

Related Publications (1)

• Mekitarian Filho E, Robinson F, de Carvalho WB, Gilio AE, Mason KP. Intranasal dexmedetomidine for sedation for pediatric computed tomography imaging. J Pediatr. 2015 May;166(5):1313-1315.e1. doi: 10.1016/j.jpeds.2015.01.036. Epub 2015 Mar 6.

  PMID: 25748567 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Keira Mason, MD

  Boston Children's Hospital, Harvard Medical School

  STUDY DIRECTOR

Central Study Contacts

Eduardo Mekitarian Filho, MD, PhD

CONTACT

+55 11 30919333; emf2002@uol.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MsC, PhD

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 16, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

BR (1)