ArticleCritical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine2023
Perioperative dexmedetomidine compared to midazolam in children undergoing open-heart surgery: A pilot randomised controlled trial.
Article in Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- Midazolam for sedation of infants in the neonatal intensive care unit.The Cochrane database of systematic reviews · 2025Pooled it
- Drug-Related Side Effects and Contributing Risk Factors in Children With Congenital Heart Disease: A Cross-Sectional Study.Health science reports · 2025Article
- The Australian and New Zealand Intensive Care Society Paediatric Study Group (ANZICS PSG): 20 Years of Collaborative Research.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2025Article
- Efficacy and safety of analgosedation with dexmedetomidine in critically ill mechanically ventilated children: a systematic review and meta-analysis of randomized controlled trials.Intensive care medicine. Paediatric and neonatal · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: 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. Design: Double blinded, pilot randomized controlled trial. Setting: Cardiac operating theatre and paediatric intensive care unit in Brisbane, Australia. Participants: Infants (≤12 months of age) undergoing their first surgical repair of a congenital heart defect. Interventions: Dexmedetomidine (up to 1.0mcg/kg/hr) versus midazolam (up to 80mcg/kg/hr), commenced in the cardiac operating theatre prior to surgery. Main outcome measures: 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. Results: 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. Conclusions: 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. Clinical trial registration: ACTRN12615001304527.
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