Perioperative dexmedetomidine compared to midazolam in children undergoing open-heart surgery: A pilot randomised controlled trial.

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.

The effect of a parental preparation video (Take5) on child and parent anxiety during anaesthetic induction: a protocol for a randomised controlled trial.

BACKGROUND: Children undergoing anaesthetic induction experience peri-operative anxiety associated with negative outcomes including emergence delirium, short- and long-term maladaptive behaviour and increased postoperative analgesic requirements. This stems from children's limited ability to communicate, cope, and regulate intense emotions, leading to high dependency on parental emotional regulation. Previous interventions including video modelling, education and distraction techniques before and during anaesthetic induction have demonstrated significant reduction of anxiety levels. No existing interventions combines evidenced-based psychoeducation video with distraction techniques to support parents to moderate peri-operative anxiety. This study aims to test the efficacy of the Take5 video (now referred to as 'Take5'), a short and cost-efficient intervention for child peri-operative anxiety. METHODS: A randomised, controlled, superiority trial of Take5 compared to standard care. Take5 was developed by paediatric anaesthetists, child psychologists and a consumer panel of parents of children who had experienced surgery and anaesthesia. Children aged 3-10 years presenting for elective surgery at a quaternary paediatric facility will be randomly allocated to the intervention group or standard care. Intervention group parents will be shown Take5 prior to accompanying their child for anaesthesia induction. Primary outcomes include child and parent anxiety at induction, measured by the Modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF), the Peri-operative Adult-Child Behavior Interaction Scale (PACBIS) and the Induction Compliance Checklist (ICC). Secondary outcomes include post-operative pain, emergence delirium, parental satisfaction, cost-effectiveness, parent and child psychological well-being at 3 months post procedure and video intervention acceptability. DISCUSSION: Perioperative anxiety is associated with negative outcome in children including higher pharmacological intervention, delayed procedures, and poor post-recovery outcomes resulting in financial burden on health systems. Current strategies minimising paediatric procedural distress are resource-intensive and have been inconsistent in reducing anxiety and negative postoperative outcomes. The Take5 video is an evidence-driven resource that is designed to prepare and empower parents. The success of Take5 will be evaluated by measuring differences in patient (acute and 3-month), family (satisfaction, acceptability), clinician (feasibility) and health service (cost) outcomes, with each anticipated to benefit children. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry (ACTRN12621001337864) and Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/21/QCHQ/73894).

A comparison of anesthetic protective barriers for the management of COVID-19 pediatric patients.

BACKGROUND: Barrier techniques, such as plastic sheets or intubation boxes, are purported to offer additional protection for healthcare workers. AIMS: To assess the functionality, perceived safety, droplet protection, and aerosol protection of several barrier techniques. METHODS: Firstly, a simulation study with 12 different laryngoscopists was conducted to assess the time taken to perform an intubation (via direct laryngoscopy, via video laryngoscopy, and via a bougie) with four different barrier techniques (personal protective equipment only, a plastic sheet, a tented plastic sheet, and an intubation box). Secondly, a cough at the time of intubation was simulated using ultraviolet dye to assess the spread of droplets; and thirdly, smoke was used to assess the spread of aerosols. RESULTS: Intubation time using the box was noninferior to using no barrier. Based on subjective ratings by the laryngoscopists, the most functional technique was no barrier followed by the intubation box, then the tented sheet, and then the plastic sheet. The technique that conferred the highest feeling of safety to the laryngoscopists was the intubation box, followed by the tented sheet, then no barrier, and then the plastic sheet. All the barriers prevented the ultraviolet dye contaminating the head and torso of the laryngoscopist. Smoke remained within the intubation box if plastics sheets were used to cover the openings and suction was ineffective at clearing it. With no barrier in place, smoke was effectively cleared away from the patient in a theater with laminar flow but tended to spread up toward the laryngoscopist in a room without laminar flow. CONCLUSIONS: A well-designed intubation box is an effective barrier against droplets and is noninferior to no barrier in relation to intubation time. However, a box interferes with laminar flow in theaters with formal ventilation systems and may result in accumulation of aerosols if it is completely enclosed.

Legal Implications of Personal Protective Equipment Use When Treating Patients for COVID-19 (SARS-CoV-2).

Front-line health care personnel, including anaesthetists, otolaryngologists, and other health professionals dealing with acute cases of coronavirus, face a high risk of infection and thus mortality. The scientific evidence establishes that to protect them, hospital protocols should require that wearing of the highest levels of personal protective equipment (PPE) be available for doctors and nurses performing aerosol-generating procedures, such as intubation, sputum induction, open suctioning of airways, bronchoscopy, etc. of COVID-19 patients. Although several international bodies have issued recommendations for a very high-level PPE to be used when these procedures are undertaken, the current PPE guidelines in Australia have tended to be more relaxed, and hospital authorities relying on them might not comply with legal obligations to their employee health care workers. Failure to provide high-level PPE in many hospitals is of concern for a large number of health care workers; this article examines the scientific literature on the topic and provides a legal perspective on hospital authorities' possible liability in negligence.