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

• Family-centred perioperative care for anaesthesia (Other): The 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.

Primary outcomes

• The incidence of emergency delirium [At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;]: 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 [At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;]: 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 [at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery]: 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 [Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery]: 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 [Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.]: Quality of life score will be assessed with Pediatric Quality of Life Inventory 4.0 (PedsQL4.0).
• Compliance of anaesthesia induction [The period anaesthesia induction.]: Compliance of anaesthesia induction in children will be assessed with Induction Compliance Checklist (ICC).
• Postoperative pain score [At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.]: Postoperative pain score in children will be assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC).
• Preoperative anxiety of children [Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.]: Preoperative anxiety of children will be assessed with the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF).
• Preoperative anxiety of parents [Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.]: Preoperative anxiety of parents will be assessed with State Trait Anxiety Inventory (STAI).

Sex: All, ages: 2 Years to 6 Years

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.

• Results publication: Chen J, Hu J, Zheng C, Song S, Yang C, Ye F, Li T. Effect of family-centred perioperative care for anaesthesia on the incidence of emergence delirium in children after surgery: a protocol for a randomised controlled trial in China. BMJ Open. 2025 Jul 6;15(7):e089863. doi: 10.1136/bmjopen-2024-089863. PMID 40623754

• Ting Li, MD. PhD, Principal investigator, Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China