Clinical Trials Directory

Trials / Completed

CompletedNCT02555605

Dexmedetomidine Sedation in Children With Respiratory Morbidities

Feasibility of Dexmedetomidine in Children With Respiratory Morbidities Undergoing Deep Sedation for Magnetic Resonance Imaging

Status
Completed
Phase
Study type
Observational
Enrollment
19 (actual)
Sponsor
Universitair Ziekenhuis Brussel · Academic / Other
Sex
All
Age
1 Month – 16 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDexmedetomidineChildren 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.

Timeline

Start date
2013-11-01
Primary completion
2015-07-01
Completion
2015-07-01
First posted
2015-09-21
Last updated
2015-09-21

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02555605. Inclusion in this directory is not an endorsement.