Dexmedetomidine Sedation in Children With Respiratory Morbidities

Completed

• Conditions: Respiratory Morbidity

• Registration Number: NCT02555605
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Electronic medical records of children with at least 3 characteristics of respiratory morbidities were retrospectively reviewed. All study patients received dexmedetomidine bolus over 10 min followed by a continuous infusion to achieve a minimum Ramsay Sedation Score of 5. Patients were monitored for hemodynamics, total dose of dexmedetomidine received, adverse events experienced and sedation characteristics.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2015-08-11
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-17
• Last Update Submitted: 2015-09-17
• Study First Posted: 2015-09-21
• Last Update Posted: 2015-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the occurrence of successful sedation	1 hour	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).

Secondary Outcome Measures

Name	Time	Method
the presence of nausea and vomiting.	4 hours	defined as the occurrence of nausea and vomitting, expressed in "yes" or "no"
the presence of bradycardia	4 hours	Based on age-adjusted criteria, bradycardia was defined as a HR \<20% below the lower limit of the normal ranges expressed in beats/min
the presence of hypertension	4 hours	Based on age-adjusted criteria hypertension was defined as a MAP \>20% above the upper limit of the normal ranges expressed in mmHg

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Vlaams Brabant, Belgium