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Completed

NCT Number: NCT02555605

Dexmedetomidine Sedation in Children With Respiratory Morbidities

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

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Key information

Conditions

Respiratory Morbidity

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Brussel

Brussels, Vlaams Brabant, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Dexdor

Primary outcomes

  1. the occurrence of successful sedation

    Time frame: 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 outcomes

  1. the presence of bradycardia

    Time frame: 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

  2. the presence of hypertension

    Time frame: 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

  3. the presence of nausea and vomiting.

    Time frame: 4 hours

    defined as the occurrence of nausea and vomitting, expressed in "yes" or "no"

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 21, 2015
Registry last updated
Sep 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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