Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging

Traumatic Brain Injury Clinical Trial

Official title:

Intranasal Dexmedetomidine Sedation for Pediatric Computerized Tomography Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01900405
• Other study ID #: USPDex
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2013
• Last updated: July 11, 2013
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2013
• Source: University of Sao Paulo
• Contact: Eduardo Mekitarian Filho, MD, PhD
• Phone: +55 11 30919333
• Email: emf2002[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 15 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Children
• Traumatic Brain Injury

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
Brazil	University Hospital, University of Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Children's Hospital Boston

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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	Yes