About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours;
Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II;
A parent signed the informed consent form.
Disqualifiers
Suffering important organ diseases;
History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment;
History of severe hearing or visual impairment;
Children are not suitable for inhalation anaesthesia considered by the researchers;
Trial design
Parallel
Treatments tested in this trial
Family-centred perioperative care for anaesthesia
Other interventionThe patient in intervention group and parent will receive the Family-centred perioperative care for anaesthesia, including video education, anaesthesia mask practice, electronic pamphlet,etc. It is recommended that parents accompany the children during the induction of anesthesia and the recovery from anesthesia.
Treatment groups
Trial outcomes
Primary outcomes
The incidence of emergency delirium
The incidence of emergency delirium will be evaluated by the Pediatric Anesthesia Emergency Delirium scale (PAED). When the child wakes up in the PACU (the child can stay awake for more than 10 seconds), and 5min, 15min, 25min after waking up, a trained researcher will evaluate the PAED score (the maximum scores ≥10 will be diagnosed as ED).
Secondary outcomes
The severity of emergency delirium
The severity of emergency delirium was assessed according to PAED scores in those patients who suffered emergency delirium. A total score ≥12 is considered moderate emergency delirium, ≥15 is considered severe emergency delirium, and the total score of the scale is 20.
The incidence of postoperative maladaptive behaviours
Postoperative maladaptive behavioural changes at the 1, 2, 3, 7±2, 14±3 days and 3 months±5 days after surgery will be assessed with Post Hospitalization Behaviour Questionnaire (PHBQ). When total score greater than 0 will be considered as postoperative maladaptive behaviours.
Sleep quality
Sleep quality before surgery and at 7±2, 14±3 days and 3 months ±5 days after surgery, assessed with Children's Sleep Habits Questionnaire (CSHQ).
Quality of life score
Quality of life score will be assessed with Pediatric Quality of Life Inventory 4.0 (PedsQL4.0).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital of Wenzhou Medical University
Lead sponsor
Jinhua Municipal Central Hospital
Collaborator
Lishui Country People's Hospital
Collaborator
Ningbo No.2 Hospital
Collaborator
The Central Hospital of Lishui City
Collaborator