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Dexmedetomidine Sedation in Children With Respiratory Morbidities

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02555605
Enrollment
19
Registered
2015-09-21
Start date
2013-11-30
Completion date
2015-07-31
Last updated
2015-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Morbidity

Keywords

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

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.

Interventions

DRUGDexmedetomidine

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.

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the occurrence of successful sedation1 hourcompletion 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

MeasureTime frameDescription
the presence of bradycardia4 hoursBased 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 hypertension4 hoursBased on age-adjusted criteria hypertension was defined as a MAP \>20% above the upper limit of the normal ranges expressed in mmHg
the presence of nausea and vomiting.4 hoursdefined as the occurrence of nausea and vomitting, expressed in yes or no

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026