Condition category
Surgery
Date applied
30/03/2014
Date assigned
19/05/2014
Last edited
19/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study in children looking at their confusion when they wake up from anesthesia for dental surgery.

Who can participate?
All healthy children between 18 months and 2 years of age who have to undergo dental surgery needing anesthesia can take part.

What does the study involve?
Parents are asked to fill out some questionnaires (this takes 20 minutes) and their child will be observed by a research nurse who scores their child on anxiety before anesthesia and on confusion when he/she wakes up from anesthesia.

What are the possible benefits and risks of participating?
Apart from more attention to their child, there is no direct benefit in participating in the study, neither is there any risk involved.

Where is the study run from?
Queen Paola Children’s Hospital, Antwerp (Belgium).

When is the study starting and how long is it expected to run for?
The study started in April 2014 and is expected to run until April 2015.

Who is funding the study?
Department of Anesthesia, ZNA Middelheim – Queen Paola Children’s Hospital (Belgium).

Who is the main contact?
J. Berghmans M.D.
johan.berghmans@zna.be
Phone: +32 03 2803995

Trial website

Contact information

Type

Scientific

Primary contact

Dr Johan Berghmans

ORCID ID

Contact details

Lindendreef 1
Antwerp
2020
Belgium
+32 (0)3 2803995
johan.berghmans@zna.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B009201420027

Study information

Scientific title

The influence of preoperative emotional and behavioral functioning of children between 1.5 and 12 on postoperative emergence delirium (ED) after dental surgery in day care

Acronym

CBCL-ANES-ED

Study hypothesis

Primary hypothesis:
What is the influence of emotional and behavioral functioning (externalising/internalising) 6 months prior to surgery of a child between 1.5 and 12 years old undergoing dental surgery on ED at awakening?
Using:
1. The Pediatric Anesthesia Emergence Delirium Scale (PAED)
2. A short Additional Structured Behavior Observation (ASBO)

Secondary hypothesis:
1. What is the influence of emotional and behavioral functioning (externalising/internalising) 6 months prior to surgery of a child between 1.5 and 12 years old undergoing dental surgery on postoperative pain at awakening?
2. What is the relationship between the state anxiety of the child measured/observed with the modified Yale Preoperative Anxiety Scale (mYPAS), the preoperative anxiety indicated by the child itself (group 6–12 years old) using a Visual Analogue Scale (VASanxiety-child-6-12) on the one hand and ED on the other?
3. What is the influence of the state and trait anxiety of the accompanying parent measured on the day of admission, in the operating theater and after leaving the operating theater with Spielberger’s State-Trait Anxiety Inventory (STAI) on postoperative ED?
4. Do parents of children undergoing dental surgery experience more dental fear as measured with the modified Dental Anxiety Scale (mDAS) compared to normative data?
5. What is the relationship between ED (measured with the PAED scale and the short ASBO) and the postoperative pain scores determined by a nurse using the Face (F), Legs (L), Activity (A), Cry (C), Consolability (C) Scale (FLACC scale) on the one hand and pain as measured by the parents using a Visual Analogue Scale (VASparent-child-pain-in-hospital) and by the child itself (≥ 6 years old) using a face scale Faces Pain Scale – Revised (FPS-R) on the other hand?

Additional questions:
1. Research reliability and validity of the translated anxiety observation scale – modified Yale Preoperative Anxiety Scale (mYPAS).
To determine:
1.1. Construct validity
1.2. Concurrent validity
1.3. Interrater reliability
1.4. Test-retest reliability
To be executed on a limited random sample out of a total cohort – 60/160 children (40%).

2. Pediatric Anesthesia Emergence Delirium Scale (PAED) and the Additional Structured Behavior Observation (ASBO)
2.1. Compare both observation scales and recode the PAED scale with sensitivity and specificity analysis
2.2. Determine the interrater reliability
2.3. Measure the internal consistency
2.4. To be executed on the results of the total cohort
2.5. To be executed on a limited random sample out of the total cohort - 60/160 children (40%).
Concerning content it is important to have the observation done by a second rater so that in this way the reliability and quality of the measurement can be determined. Academic journals demand more and more measurement reliability of the coders. Therefore it is necessary in this research to specifically check the reliability of the observations.

Ethics approval

Institutional Review Board (nr. 009; OG 031), 12/02/2014, EC approval number 4343

Study design

Prospective single-institution cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please email Muriel.DeVel@zna.be to request a patient information sheet

Condition

Maladaptive perioperative behavior in children

Intervention

This trial is an observation of 160 children who undergo dental surgery under anesthesia. Parents are asked to fill in a questionnaire on emotional and behavioral functioning of their child. A research nurse will make observations on anxiety at three time points:

1. On admission in the day care unit
2. When entering the operating theatre
3. At induction of anesthesia

The research nurse will also perform additional observations of emergence delirium (four time points during 20 min = T1 at 5 min, T2 at 10 min, T3 at 15 min, T4 at 20 min) when the child wakes up after anesthesia (additionally followed by two pain score observations at 1 hour and 2 hours postoperative by the research nurse). The total duration of observation takes approximately 6 hours for each child (day care surgery). There is no further follow-up at home, only intrahospital observations during admission for their surgery.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

The scores on the Pediatric Anesthesia Emergence Delirium Scale (PAED) scale during 20 minutes postoperative and parallel to this the item score on the Additional Structured Behavior Observation (ASBO)

Secondary outcome measures

Postoperative pain scores concerning the child:
1. Just after waking up from anesthesia together with emergence delirium observations (four time points during 20 min every 5 min) an additional pain observation is done by using an observational pain measuring tool (FLACCnurse). When leaving the Post Operative Care Unit (PACU) two additional pain measurements are done again using a FLACCnurse scale (T1: 1 hour after leaving the PACU and T2: 2 hours after leaving the PACU).
2. Also at these same time points the parents are asked to assess their child’s pain by using a Visual Analogue Scale (VAS).
3. If the child is older than 6 years of age the child is asked to assess its pain by itself using a Faces Pain Scale – revised (FPS-R) (same time points as the parental assessment).

Taking note of:
1. The total intake of analgesics
2. Postoperative nausea and vomiting

Overall trial start date

01/04/2014

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age from 1.5 to 12 years old
2. Intervention: dental surgery anesthesia
3. Information and consent forms of the parents
4. Accompanying parent present at induction
5. Parents who speak and understand Dutch
6. No premedication (the norm in Queen Paola Children’s Hospital)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. Known mental/cognitive retardation
2. American Society Anesthesiologists ASA physical status I and II (attachment 15)
3. Children with objectified obstructive sleep apnea syndrome
4. Children with BMI > 25
5. Allergic reaction to sevoflurane and/or risk of malign hyperthermia

Secondary exclusion criteria:
1. When parent or child no longer wish to participate
2. When a life-threatening situation occurs during the procedure (e.g., asystole)

Recruitment start date

01/04/2014

Recruitment end date

01/04/2015

Locations

Countries of recruitment

Belgium

Trial participating centre

Lindendreef 1
Antwerp
2020
Belgium

Sponsor information

Organisation

ZNA Middelheim - Queen Paola Children’s Hospital (Belgium)

Sponsor details

Lindendreef 1
Antwerp
2020
Belgium
+32 (0)3 2803995
johan.berghmans@zna.be

Sponsor type

Hospital/treatment centre

Website

http:/www.zna.be

Funders

Funder type

Hospital/treatment centre

Funder name

ZNA Middelheim - Queen Paola Children's Hospital (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes