NCT06396000

Brief Summary

The purpose of this study is to determine which factors contribute to prolonged stay of children in the PACU.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

April 23, 2024

Last Update Submit

May 1, 2024

Conditions

Keywords

Post-anesthesia care unitRisk factorsPediatrics

Outcome Measures

Primary Outcomes (5)

  • Anesthesia Plan Selection

    Anesthesia options include general anesthesia, combined anesthesia, pure intravenous anesthesia, and nerve block anesthesia.

    Day 1

  • Pain Score

    Evaluate pain using the Visual Analog Scale (VAS): 0 points: no pain; 1-3 points: mild pain; 4-6 points: moderate pain; 7-10 points: severe pain.

    Day 1

  • Complications in PACU

    Nausea, vomiting, chills, pain, agitation

    Day 1

  • American Society of Anesthesiologists(ASA)

    ASA I: Patients in good health, without systemic disease. ASA II: Patients with mild systemic disease, not significantly limiting daily activity. ASA III: Patients with severe systemic disease, with definite functional limitation. ASA IV: Patients with severe systemic disease that is a constant threat to life. ASA V: Moribund patients who are not expected to survive without the operation. ASA VI: Brain-dead patients whose organs are being removed for donation.

    Day 1

  • The medication usage in PACU

    Morphine, Propofol, Ketorolac, Fentanyl

    Day 1

Secondary Outcomes (1)

  • The use of PCA(Patient-Controlled Analgesia)in PACU

    Day 1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patient entering the Pediatric Post-Anesthesia Care.

You may qualify if:

  • Children aged 0-18 years old; Child entering the Pediatric Post-Anesthesia Care.
  • Emergency surgery; Pediatric patients with incomplete medical history; Pediatric patients requiring postoperative ICU care; Pediatric patients with preoperative altered consciousness; Neurological disorders; Severe liver, kidney, lung, and heart diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior nurse

Study Record Dates

First Submitted

April 23, 2024

First Posted

May 2, 2024

Study Start

May 31, 2024

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

May 3, 2024

Record last verified: 2024-05