Perioperative dexmedetomidine compared to midazolam in children undergoing open-heart surgery: A pilot randomised controlled trial.
Anaesthesia and intensive care
Cardiology and cardiac surgery
Paediatrics
Sedation
Journal
Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine
ISSN: 1441-2772
Titre abrégé: Crit Care Resusc
Pays: Netherlands
ID NLM: 100888170
Informations de publication
Date de publication:
Mar 2023
Mar 2023
Historique:
medline:
25
10
2023
pubmed:
25
10
2023
entrez:
25
10
2023
Statut:
epublish
Résumé
There is a need for evidence on the best sedative agents in children undergoing open heart surgery for congenital heart disease. This study aimed to evaluate the feasibility and safety of dexmedetomidine in this group compared with midazolam. Double blinded, pilot randomized controlled trial. Cardiac operating theatre and paediatric intensive care unit in Brisbane, Australia. Infants (≤12 months of age) undergoing their first surgical repair of a congenital heart defect. Dexmedetomidine (up to 1.0mcg/kg/hr) versus midazolam (up to 80mcg/kg/hr), commenced in the cardiac operating theatre prior to surgery. The primary outcome was the time spent in light sedation (Sedation Behavior Scale [SBS] -1 to +1); Co-primary feasibility outcome was recruitment, retention and protocol adherence. Secondary outcomes were use of supplemental sedatives, ventilator free days, delirium, vasoactive drug support, and adverse events. Neurodevelopment and health-related quality of life (HRQoL) were assessed at 12 months post-surgery. Sixty-six participants were recruited. The number of SBS scores in the light sedation range were greater in the dexmedetomidine group at 24 hours, 48 hours, and overall study duration (0-14 days) versus the midazolam group (24hr: 76/170 [45%] vs 60/178 [34%], aOR 4.14 [95% CI 0.48, 35.92]; 48hr: 154/298 [52%] vs 122/314 [39%], aOR 6.95 [95% CI 0.77, 63.13]; 0-14 days: 597/831 [72%] vs 527/939 [56%], aOR 3.93 [95% CI 0.62, 25.03]). Feasibility was established with no withdrawals or loss to follow-up at 14 days and minimal protocol deviations. There were no differences between the groups relating to clinical, safety, neurodevelopment or HRQoL outcomes. The use of dexmedetomidine was associated with more time spent in light sedation when compared with midazolam. The feasibility of conducting a blinded RCT of midazolam and dexmedetomidine in children undergoing open heart surgery was also established. The findings justify further investigation in a larger trial. ACTRN12615001304527.
Identifiants
pubmed: 37876986
doi: 10.1016/j.ccrj.2023.04.007
pii: S1441-2772(23)00009-1
pmc: PMC10581262
doi:
Types de publication
Journal Article
Langues
eng
Pagination
33-42Informations de copyright
© 2023 Published by Elsevier B.V. on behalf of College of Intensive Care Medicine of Australia and New Zealand.
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