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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Paediatric Anesthesia Emergence Delirium

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children undergoing anesthesia and being taken care of at the paediatric PACU Aged 0 - 13 years Exclusion Criteria: • None

Ages Eligible for Study
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Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |