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Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery

RecruitingNAAges 2 Years - 6 YearsAllSecond Affiliated Hospital of Wenzhou Medical Uni…
NCT06092671 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (POMBs). There is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED. Therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children, compared with routine anaesthesia.

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📋 Eligibility rules (as published)
Inclusion criteria: 1. Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours; 2. Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II; 3. A parent signed the informed consent form. Exclusion criteria: 1. Suffering important organ diseases; 2. History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment; 3. History of severe hearing or visual impairment; 4. Children are not suitable for inhalation anaesthesia considered by the researchers; 5. The parent involving in this trial spends less than three months a year with the child; 6. The parent is not competent for companionship considered by the researchers; 7. Neither father nor mother is able to participate in the screening interview and the trial.
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What it tests

  • Family-centred perioperative care for anaesthesia
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Where

1 site
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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