Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06092671

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Postoperative Complications Child Confusion Delirium Emergence Delirium Family General Anaesthesia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative Care Signs and Symptoms

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location status: Recruiting

Location contact

Ting Li, MD. PhD

CONTACT

[email protected]

+86-135-8787-6896

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • The parent involving in this trial spends less than three months a year with the child;
  • The parent is not competent for companionship considered by the researchers;
  • Neither father nor mother is able to participate in the screening interview and the trial.

Treatment and study plan

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

  1. The incidence of emergency delirium

    Time frame: 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

  1. The severity of emergency delirium

    Time frame: 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.

  2. The incidence of postoperative maladaptive behaviours

    Time frame: 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.

  3. Sleep quality

    Time frame: 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).

  4. Quality of life score

    Time frame: 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).

  5. Compliance of anaesthesia induction

    Time frame: The period anaesthesia induction.

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

  6. Postoperative pain score

    Time frame: 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).

  7. Preoperative anxiety of children

    Time frame: 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).

  8. Preoperative anxiety of parents

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Li, MD. PhD

CONTACT

[email protected]

+86-135-8787-6896

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Collaborators

  • Jinhua Municipal Central Hospital
  • Lishui Country People's Hospital
  • Ningbo No.2 Hospital
  • The Central Hospital of Lishui City

Registry information

Official study title

Effect of Family-centred Perioperative Care for Anaesthesia on Incidence of Emergency Delirium in Children After Surgery: a Protocol for a Randomised Controlled Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.