Dexmedetomidine Sedation in Children With Respiratory Morbidities

NCT02555605 | Completed

• 1 other identifier: DEXMRI20
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to determine the feasibility of dexmedetomidine in children with respiratory morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.

Conditions

Respiratory Morbidity

Keywords

children; dexmedetomidine; magnetic resonance imaging scans; deep sedation; adverse respiratory events

Outcome Measures

Primary Outcomes (1)

• the occurrence of successful sedation

  completion of imaging without requirement for rescheduling or general anaesthesia, and in the absence of adverse respiratory events such as apnoea, cough, oxygen desaturation, and bronchospasm or unplanned escalation of care (e.g. transfer from ward to paediatric intensive care unit or prolonged hospitalization).

  1 hour

Secondary Outcomes (3)

• the presence of bradycardia

  4 hours

• the presence of hypertension

  4 hours

• the presence of nausea and vomiting.

  4 hours

Interventions

Dexmedetomidine DRUG

Children up to the age of 16 years requiring MRI under deep sedation with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events. Dexmedetomidine was administered as a first bolus of 1 mcg•kg-1 over 10 min, followed by a continuous infusion at 1.0 mcg•kg-1•h-1. Sedation level was assessed by Ramsay Sedation Scale and it was initially recorded at 1-min interval. If the child failed to achieve a minimum RSS of 5, this bolus was repeated once again and the continuous infusion was subsequently increased to 2 mcg•kg-1•h-1. In addition, propofol 0.5 mg.kg-1 iv. was allowed to be administered, in patients still exhibiting movement that could interfere with image acquisition.

Also known as: Dexdor

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events and they were eligible for participation in this evaluation.

You may qualify if:

• Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities

You may not qualify if:

• Children who had an American Society of Anaesthesiologists (ASA) physical status classification IV
• Documented pre-existing cardiac conduction abnormalities
• Renal impairment

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Vlaams Brabant, 1090, Belgium

Location

Related Publications (1)

• Najafi N, Veyckemans F, Van de Velde A, Poelaert J. Usability of dexmedetomidine for deep sedation in infants and small children with respiratory morbidities. Acta Anaesthesiol Scand. 2016 Aug;60(7):865-73. doi: 10.1111/aas.12715. Epub 2016 Mar 4.

  PMID: 26940080 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Nadia Najafi, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

• Jan Poelaert, PhD MD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Data Nurse

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: September 21, 2015
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 21, 2015

Record last verified: 2015-09

Locations

BE (1)