Effect of Family-centred Perioperative Care for Anaesthesia on Incidence of Emergency Delirium in Children After Surgery: a Protocol for a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Complications
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Enrollment
- 444
- Locations
- 1
- Primary Endpoint
- The incidence of emergency delirium
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
TING LI
Principal Investigator
Second Affiliated Hospital of Wenzhou Medical University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- 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 incidence of postoperative maladaptive behaviours(at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery)
- Sleep quality(Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery)
- Quality of life score(Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.)
- Compliance of anaesthesia induction(The period anaesthesia induction.)
- Postoperative pain score(At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.)
- Preoperative anxiety of children(Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.)
- Preoperative anxiety of parents(Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.)