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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358278
• Other study ID #: EI-PAED
• Status: Completed
• Phase: N/A
• First received: January 23, 2015
• Last updated: February 3, 2015
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Delirium
• Paediatric Anesthesia Emergence Delirium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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