Evaluation and Implementation of the "Paediatric Anesthesia Emergence Delirium Scale" (PAED) in the PACU in Children Under 14 Years of Age

The goal of this study is to determine the incidence and characteristics of Emergence Delirium (ED) in children aged 0 - 13 undergoing general anesthesia and being taken care of at the paediatric PACU of the Charité Campus Virchow-Clinic. Therefore the "Paediatric Anesthesia Emergence Delirium Scale" (PAED) is used. In order to measure the patient's pain level, age-appropriate pain scales (CHIPPS or FPS-R) are applied. Risk factors for the occurrence of ED are to be determined and therapeutic approaches in case of an occurring ED are to be evaluated. Finally the future implementation of ED-monitoring in the PACU is to be prepared.

Study Overview

• Status: Completed
• Conditions: Paediatric Anesthesia Emergence Delirium

Detailed Description

Emergence Delirium is a widely known phenomenon during the recovery phase after general anesthesia in children. In spite of the existence of a vast number of studies dealing with this topic and even after the development of a validated measurement tool for ED (PAED-Scale, Sikich et al. 2004), data regarding incidence, risk factors and treatment of ED vary considerably.

This study seeks to determine the actual incidence and characteristics of Emergence Delirium (ED) in children at the paediatric PACU of the Charité Campus Virchow-Clinic. Therefore the PAED-Scale is applied in a large population of children aged 0 - 13 years undergoing general anesthesia. In addition a clinical evaluation regarding the presence of ED is conducted by the PACU nurses on the basis of their clinical experience.

In order to preserve the possibility of minimizing the influence of postoperative pain, which has been identified as a confounding variable in the measurement of ED, an age-appropriate pain score is measured simultaneously with each PAED-Score. The Children's and Infants Postoperative Pain Scale (CHIPPS) (Büttner, 1998) is used for children aged 0 - 4 years. The Faces Pain Scale-Revised (FPS-R) (Hicks et al. 2001) is used for older children.

Besides the study aims to identify possible factors that are associated with a higher incidence of ED. Therefore perioperative data (anesthetic and analgetic agents, duration of anesthesia, premedication, volume therapy etc.) is obtained.

In case of the occurrence of ED additional data (duration of ED, treatment of ED) is collected.

All data is collected by using a questionnaire that is completed by the anesthesists and the PACU staff.

• Study Type: Observational
• Enrollment (Actual): 821

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All children (age 0-13) receiving anesthetic care for operative procedures and are cared for in the post-anesthesia care unit are monitored for emergence delirium and therapeutic measures.

Description

Inclusion Criteria:

• Children undergoing anesthesia and being taken care of at the paediatric PACU
• Aged 0 - 13 years

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paediatric Anesthesia Emergence Delirium (PAED) Score	(PAED) Score at four different points of time: 5 - 10 minutes after awakening; At clinical signs of ED (only if applicable); After ED therapy (only if applicable); At discharge from the PACU Age-appropriate pain score simultaneously with each PAED Score; Age 0 - 4: Children's and Infants Postoperative Pain Scale (CHIPPS); Age 5 - 13: Faces Pain Scale-Revised (FPS-R)	It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation procedure	Kind of surgical procedure	At time of surgery
Duration of anesthesia		At time of surgery
Induction of anesthesia (anesthetic agents)		At time of surgery
Maintenance of anesthesia (anesthetic agents)		At time of surgery
Analgesic agents		It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Fluid balance	Fluid and volume administration and balance	At time of surgery
Blood transfusions		They are measured until the end of PACU stay - or for a maximum of 5 days
Duration of stay in the PACU		Period of PACU stay
Duration of Emergence Delirium		It is measured until the end of PACU stay - or for a maximum of 5 days
Pharmacological treatment of Emergence Delirium		It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Non-pharmacological treatment of Emergence Delirium		It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Pain scores	Age 0 - 4: Children's and Infants Postoperative Pain Scale (CHIPPS) ◦Age 5 - 13: Faces Pain Scale-Revised (FPS-R)	It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Anesthesia	General Anesthesia or general anesthesia combined with regional anesthesia	At time of surgery

Other Outcome Measures

Outcome Measure	Time Frame
Gender	At the beginning of the investigation
Age	At the beginning of the investigation
Height	At the beginning of the investigation
Weight	At the beginning of the investigation
ASA-Classification	At the beginning of the investigation
Admission diagnosis	At the beginning of the investigation
Comorbidities	At the beginning of the investigation
Long-term medication	At the beginning of the investigation
Premedication	At the beginning of the investigation
PONV prophylaxis	At the beginning of the investigation

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: EI-PAED