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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-6
SponsorSecond Affiliated Hospital of Wenzhou Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Family-centred perioperative care for anaesthesia

    Other intervention

    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.

Treatment groups

444 Participants
are divided into 2 treatment groups
Group A: Family-Centered group (F group)Experimental treatment 1 intervention
Group B: Routine group (R group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

1

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;
2

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
3

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
4

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.

Other outcomes

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