Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging

Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging

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

Study Overview

• Status: Unknown
• Conditions: Children; Traumatic Brain Injury
• Intervention / Treatment: Drug: Dexmedetomidine

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05508000
      • Recruiting
      • University Hospital, University of Sao Paulo
      • Contact: Alfredo Gilio, MD, PhD; Phone Number: 919409 +55 11 30919200; Email: aegilio@uol.com.br
      • Principal Investigator: Eduardo Mekitarian Filho, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dexmedetomidine; All children undergoing	Drug: Dexmedetomidine; Other Names: Precedex (brand name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of IN dexmedetomidine for pediatric CT imaging	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.	At admission and every 5 minutes after sedation

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Boston Children's Hospital
• Investigators: Study Director: Keira Mason, MD, Boston Children's Hospital, Harvard Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: July 9, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimate): July 16, 2013

Study Record Updates

• Last Update Posted (Estimate): July 16, 2013
• Last Update Submitted That Met QC Criteria: July 11, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Children; Dexmedetomidine; Computerized Tomography; Administration, Intranasal
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: USPDex