Evaluation and Implementation of the "Paediatric Anesthesia Emergence Delirium Scale" (PAED) in the PACU in Children Under 14 Years of Age
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 821
- Locations
- 1
- Primary Endpoint
- Paediatric Anesthesia Emergence Delirium (PAED) Score
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children undergoing anesthesia and being taken care of at the paediatric PACU
- •Aged 0 - 13 years
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Paediatric Anesthesia Emergence Delirium (PAED) Score
Time Frame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
(PAED) Score at four different points of time: 1. 5 - 10 minutes after awakening 2. At clinical signs of ED (only if applicable) 3. After ED therapy (only if applicable) 4. 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)
Secondary Outcomes
- Induction of anesthesia (anesthetic agents)(At time of surgery)
- Maintenance of anesthesia (anesthetic agents)(At time of surgery)
- Fluid balance(At time of surgery)
- 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)
- Pain scores(It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours)
- Anesthesia(At time of surgery)
- Operation procedure(At time of surgery)
- Duration of anesthesia(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)
- Blood transfusions(They are 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)
Investigators
Claudia Spies
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Camus Virchow -Klinikum
Charite University, Berlin, Germany