RecruitingNot ApplicableNCT06092671

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

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


Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Enrollment

444 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 2 YearsMax Age: 6 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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.

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Interventions

OTHERFamily-centred perioperative care for anaesthesia

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.


Locations(1)

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

Wenzhou, Zhejiang, China

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NCT06092671


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