Paediatric Anesthesia Emergence Delirium Clinical Trial
Official title:
Evaluation and Implementation of the "Paediatric Anesthesia Emergence Delirium Scale" (PAED) in the PACU in Children Under 14 Years of Age
Verified date | February 2015 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
Status | Completed |
Enrollment | 821 |
Est. completion date | January 2015 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 13 Years |
Eligibility |
Inclusion Criteria: - Children undergoing anesthesia and being taken care of at the paediatric PACU - Aged 0 - 13 years Exclusion Criteria: • None |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gender | At the beginning of the investigation | No | |
Other | Age | At the beginning of the investigation | No | |
Other | Height | At the beginning of the investigation | No | |
Other | Weight | At the beginning of the investigation | No | |
Other | ASA-Classification | At the beginning of the investigation | No | |
Other | Admission diagnosis | At the beginning of the investigation | No | |
Other | Comorbidities | At the beginning of the investigation | No | |
Other | Long-term medication | At the beginning of the investigation | No | |
Other | Premedication | At the beginning of the investigation | No | |
Other | PONV prophylaxis | At the beginning of the investigation | No | |
Primary | 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 | No |
Secondary | Operation procedure | Kind of surgical procedure | At time of surgery | No |
Secondary | Duration of anesthesia | At time of surgery | No | |
Secondary | Induction of anesthesia (anesthetic agents) | At time of surgery | No | |
Secondary | Maintenance of anesthesia (anesthetic agents) | At time of surgery | No | |
Secondary | Analgesic agents | It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours | No | |
Secondary | Fluid balance | Fluid and volume administration and balance | At time of surgery | No |
Secondary | Blood transfusions | They are measured until the end of PACU stay - or for a maximum of 5 days | No | |
Secondary | Duration of stay in the PACU | Period of PACU stay | No | |
Secondary | Duration of Emergence Delirium | It is measured until the end of PACU stay - or for a maximum of 5 days | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No |
Secondary | Anesthesia | General Anesthesia or general anesthesia combined with regional anesthesia | At time of surgery | No |