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Active, not recruiting Observational

Turkish Version of The Pediatric Anesthesia Emergency Delirium

NCT06931249 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-03-24
Last updated
2025-04-17

Condition(s) studied

Emergence Delirium, Anesthesia

Investigational drug(s) / intervention(s)

The observational study

The observational study: This study is being conducted to create a Turkish version of the English version of the PAED scale, which did not exist before, and to determine its cultural suitability.

Study summary

Emergence delirium (ED) is a mental disorder seen in children during recovery from general anesthesia. The Pediatric Anesthesia Emergence Delirium (PAED) scale is the only valid scale to assess ED in pediatric patients undergoing general anesthesia. The aim of this study is to translate and adapt the PAED scale to Turkish.

A five-stage translation and adaptation process will be performed. The reliability of the Turkish version of the PAED scale was independently assessed by a group of two raters (anesthesiologists or postanesthesia care unit nurses) in pediatric patients after general anesthesia. ED was defined by a cut-off point of ≥ 10 points on the PAED scale

Eligibility

Sex
ALL
Min age
2 Years
Max age
16 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Parents consented to the study, 2. Transferred to PACU after general anesthesia, 3. Between 2-16 years of age, 4. ASA physical status class I-II, 5. Cognitively intact children. Exclusion Criteria: 1. Children without parental consent, 2. Children under 2 years of age and over 16 years of age, 3. Children with ASA physical status class III and above, 4. Children who underwent surgery under general anesthesia under emergency conditions, 5. Children with cognitive and behavioral disorders, 6. Children who developed major complications after the operation, 7. Children who are expected to require postoperative mechanical ventilation.

Primary outcome measure(s)

  • Turkish version of the pediatric anesthesia emergency delirium (PAED) scale — 6 months
    The PAED scale consists of the following 5 items; 1- degree of eye contact, 2- purposeful actions, 3- awareness of the environment, 4- restlessness and 5- inconsolability. Each item is assigned a score between 0 and 4,

Trial sites (1)

FacilityCityRegionStatus
Selcuk University Konya Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06931249 on ClinicalTrials.gov ↗ ← All trials in Turkey