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Active, Not Recruiting

NCT Number: NCT06931249

Turkish Version of The Pediatric Anesthesia Emergency Delirium

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Emergence Delirium, Anesthesia Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University

Konya, 42250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Parents consented to the study,
  • Transferred to PACU after general anesthesia,
  • Between 2-16 years of age,
  • ASA physical status class I-II,
  • Cognitively intact children.

Exclusion criteria

  • Children without parental consent,
  • Children under 2 years of age and over 16 years of age,
  • Children with ASA physical status class III and above,
  • Children who underwent surgery under general anesthesia under emergency conditions,
  • Children with cognitive and behavioral disorders,
  • Children who developed major complications after the operation,
  • Children who are expected to require postoperative mechanical ventilation.

Treatment and study plan

The observational study

Behavioral

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.

Primary outcomes

  1. Turkish version of the pediatric anesthesia emergency delirium (PAED) scale

    Time frame: 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,

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

Turkish Version of The Pediatric Anesthesia Emergency Delirium (PAED) Scale: Translation and Cross-Cultural Adaptation

Acronym: PAED

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Apr 17, 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.

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