Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging

NCT ID: NCT01900405

Last Updated: 2013-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-01-31

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.

Conditions

Traumatic Brain Injury; Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Dexmedetomidine

All children undergoing

Dexmedetomidine

Intervention Type: DRUG

Interventions

Dexmedetomidine

Intervention Type: DRUG

Other Intervention Names

Precedex (brand name)

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Mekitarian Filho

MD, MsC, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keira Mason, MD

Role: STUDY_DIRECTOR

Boston Children's Hospital, Harvard Medical School

Locations

University Hospital, University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Eduardo Mekitarian Filho, MD, PhD

Role: CONTACT

emf2002@uol.com.br

+55 11 30919333 ext. 919333

Facility Contacts

Alfredo Gilio, MD, PhD

Role: primary

aegilio@uol.com.br

+55 11 30919200 ext. 919409

References

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.

Reference Type: DERIVED

PMID: 25748567 (View on PubMed)

Other Identifiers

USPDex

Identifier Type: -

Identifier Source: org_study_id