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

Second Affiliated Hospital of Wenzhou Medical University444 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

444

Conditions

Postoperative Complications Child Family Emergence Delirium General Anaesthesia

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

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).

Time frame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;

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.

Time frame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;

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.

Time frame: at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery

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).

Time frame: Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery

Quality of life score

Quality of life score will be assessed with Pediatric Quality of Life Inventory 4.0 (PedsQL4.0).

Time frame: Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.

Compliance of anaesthesia induction

Compliance of anaesthesia induction in children will be assessed with Induction Compliance Checklist (ICC).

Time frame: The period anaesthesia induction.

Postoperative pain score

Postoperative pain score in children will be assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC).

Time frame: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.

Preoperative anxiety of children

Preoperative anxiety of children will be assessed with the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF).

Time frame: Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.

Preoperative anxiety of parents

Preoperative anxiety of parents will be assessed with State Trait Anxiety Inventory (STAI).