Paediatric Anesthesia Emergence DeliriumNCT02358278
Evaluation and Implementation of the "Paediatric Anesthesia Emergence Delirium Scale" (PAED) in the PACU in Children Under 14 Years of Age
An observational study of Paediatric Anesthesia Emergence Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages Up to 13 years
- Conditions the study is for
- Paediatric Anesthesia Emergence Delirium
- How many people
- 821 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 13 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children undergoing anesthesia and being taken care of at the paediatric PACU
- Aged 0 - 13 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
Berlin, 13353
About this study
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.
Read the 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.
- Conditions
- Paediatric Anesthesia Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Secondary outcomes (13)
Operation procedure
Kind of surgical procedure
Measured: At time of surgery
Duration of anesthesia
Measured: At time of surgery
Induction of anesthesia (anesthetic agents)
Measured: At time of surgery
Maintenance of anesthesia (anesthetic agents)
Measured: At time of surgery
Analgesic agents
Measured: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Fluid balance
Fluid and volume administration and balance
Measured: At time of surgery
Blood transfusions
Measured: They are measured until the end of PACU stay - or for a maximum of 5 days
Duration of stay in the PACU
Measured: Period of PACU stay
Duration of Emergence Delirium
Measured: It is measured until the end of PACU stay - or for a maximum of 5 days
Pharmacological treatment of Emergence Delirium
Measured: 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
Measured: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Pain scores
Age 0 - 4: Children's and Infants Postoperative Pain Scale (CHIPPS)
◦Age 5 - 13: Faces Pain Scale-Revised (FPS-R)
Measured: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Anesthesia
General Anesthesia or general anesthesia combined with regional anesthesia
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric Anesthesia Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358278
- Sponsor's protocol ID
- EI-PAED
- Status last verified
- Feb 2015
- First submitted
- 23 Jan 2015
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Implementation of the "Paediatric Anesthesia Emergence Delirium Scale" (PAED) in the PACU in Children Under 14 Years of Age
- ClinicalTrials.gov ID
- NCT02358278
- Acronym / sponsor ID
- EI-PAED
- Conditions
- Paediatric Anesthesia Emergence Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 821 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Children undergoing anesthesia and being taken care of at the paediatric PACU
- Aged 0 - 13 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
13 secondary outcomes
Operation procedure
Time frame: At time of surgery
Duration of anesthesia
Time frame: At time of surgery
Induction of anesthesia (anesthetic agents)
Time frame: At time of surgery
Maintenance of anesthesia (anesthetic agents)
Time frame: At time of surgery
Analgesic agents
Time frame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Fluid balance
Time frame: At time of surgery
Blood transfusions
Time frame: They are measured until the end of PACU stay - or for a maximum of 5 days
Duration of stay in the PACU
Time frame: Period of PACU stay
Duration of Emergence Delirium
Time frame: It is measured until the end of PACU stay - or for a maximum of 5 days
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
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
Pain scores
Time frame: It is measured until the end of post-anesthesia care unit (PACU) stay - or for a maximum of 24 hours
Anesthesia
Time frame: At time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Anesthesia Emergence Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.