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Completed

NCT Number: NCT02358278

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

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.

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Key information

Conditions

Paediatric Anesthesia Emergence Delirium

Age range

Up to 13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. 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:

    • 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)

Secondary outcomes

  1. Operation procedure

    Time frame: At time of surgery

    Kind of surgical procedure

  2. Duration of anesthesia

    Time frame: At time of surgery

  3. Induction of anesthesia (anesthetic agents)

    Time frame: At time of surgery

  4. Maintenance of anesthesia (anesthetic agents)

    Time frame: At time of surgery

  5. Analgesic agents

    Time frame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours

  6. Fluid balance

    Time frame: At time of surgery

    Fluid and volume administration and balance

  7. Blood transfusions

    Time frame: They are measured until the end of PACU stay - or for a maximum of 5 days

  8. Duration of stay in the PACU

    Time frame: Period of PACU stay

  9. Duration of Emergence Delirium

    Time frame: It is measured until the end of PACU stay - or for a maximum of 5 days

  10. Pharmacological treatment of Emergence Delirium

    Time frame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours

  11. Non-pharmacological treatment of Emergence Delirium

    Time frame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours

  12. Pain scores

    Time frame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours

    Age 0 - 4: Children's and Infants Postoperative Pain Scale (CHIPPS)

    ◦Age 5 - 13: Faces Pain Scale-Revised (FPS-R)

  13. Anesthesia

    Time frame: At time of surgery

    General Anesthesia or general anesthesia combined with regional anesthesia

Other outcomes

  1. Gender

    Time frame: At the beginning of the investigation

  2. Age

    Time frame: At the beginning of the investigation

  3. Height

    Time frame: At the beginning of the investigation

  4. Weight

    Time frame: At the beginning of the investigation

  5. ASA-Classification

    Time frame: At the beginning of the investigation

  6. Admission diagnosis

    Time frame: At the beginning of the investigation

  7. Comorbidities

    Time frame: At the beginning of the investigation

  8. Long-term medication

    Time frame: At the beginning of the investigation

  9. Premedication

    Time frame: At the beginning of the investigation

  10. PONV prophylaxis

    Time frame: At the beginning of the investigation

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Feb 6, 2015
Registry last updated
Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.