Clinical trial NCT02358278: Evaluation and Implementation of the "Paediatric Anesthesia Emergence Delirium Scale" (PAED) in the PACU in Children Under 14 Years of Age
Official title: Evaluation and Implementation of the "Paediatric Anesthesia Emergence Delirium Scale" (PAED) in the PACU in Children Under 14 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paediatric Anesthesia Emergence Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 821
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• None

Primary outcomes:
measure: Paediatric Anesthesia Emergence Delirium (PAED) Score
timeFrame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Secondary outcomes:
measure: Operation procedure
timeFrame: At time of surgery
measure: Duration of anesthesia
timeFrame: At time of surgery
measure: Induction of anesthesia (anesthetic agents)
timeFrame: At time of surgery
measure: Maintenance of anesthesia (anesthetic agents)
timeFrame: At time of surgery
measure: Analgesic agents
timeFrame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
measure: Fluid balance
timeFrame: At time of surgery
measure: Blood transfusions
timeFrame: They are measured until the end of PACU stay - or for a maximum of 5 days
measure: Duration of stay in the PACU
timeFrame: Period of PACU stay
measure: Duration of Emergence Delirium
timeFrame: It is measured until the end of PACU stay - or for a maximum of 5 days
measure: Pharmacological treatment of Emergence Delirium
timeFrame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
measure: Non-pharmacological treatment of Emergence Delirium
timeFrame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
measure: Pain scores
timeFrame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
measure: Anesthesia
timeFrame: At time of surgery
Other outcomes:
measure: Gender
timeFrame: At the beginning of the investigation
measure: Age
timeFrame: At the beginning of the investigation
measure: Height
timeFrame: At the beginning of the investigation
measure: Weight
timeFrame: At the beginning of the investigation
measure: ASA-Classification
timeFrame: At the beginning of the investigation
measure: Admission diagnosis
timeFrame: At the beginning of the investigation
measure: Comorbidities
timeFrame: At the beginning of the investigation
measure: Long-term medication
timeFrame: At the beginning of the investigation
measure: Premedication
timeFrame: At the beginning of the investigation
measure: PONV prophylaxis
timeFrame: At the beginning of the investigation
Locations:
city: Berlin
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: