Child Behavior, Problem Behavior
Conditions
Keywords
Child Behavior, Problem Behavior, postoperative behaviour problems
Brief summary
The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA)
Detailed description
The process of surgery and anaesthesia can be an extremely frightening and stressful event for a child, and is frequently followed by negative postoperative behavioural changes. This Event could be associated with poor postoperative outcome and long term behavior problems like anxiety, eating or sleeping disorders. The aim of this study is to investigate long-lasting or later behavioral changes in children in the context of different anesthesia techniques (Inhalation anesthesia vs. TIVA). After anesthesia initiation, anesthesia maintenance should be done with sevoflurane or Tiva. The effect of behavioral changes in children in the context of anesthesia techniques should be evaluate by post hospitalisation behavior and Strengths and Difficulties Questionnaire at first, second and fourth week. Early postoperative problems like postoperative nausea and vomiting, pain level, pain therapy and postoperative awareness should be evaluate too.
Interventions
PROCEDURETIVA
TIVA is use to anesthesia maintenance after anesthesia induction (Propofol 10mg/kg/h, Remifentanil 0.2mcg/kg/min, dose adaptation as required for sufficient anesthesia)
PROCEDURESevoflurane
Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)
Sponsors
University Children's Hospital, Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* elective Operation * operation in general anesthesia in combination with regional anesthesia * Age 2-10 years * ASA classification 1 or 2 (without severe basic disease or disability)
Exclusion criteria
* Lack of Consensus * general anesthesia during the last 3 months before or 4 weeks after the procedure * PONV prophylaxis with droperidol * severe known growth factor * mental pre-existing conditions and behavioral abnormalities * contraindications for one of the used study medications * insufficient regional anesthesia * secondary intervention within of the 4-week follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively | first week postoperative | child's PHBQ score first week postoperatively |
| SDQ Questionnaire score postoperatively | first week postoperative | child's SDQ score first week postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain medication | in the first postoperative week | All pain medications are recorded during the first postoperative week.Nurses and parents recorded all substance and application times by questionnaire. |
| postoperative pain Level (by VAS) | in the first postoperative week (3 times a day) | Visual Analog Scale for Pain (VAS Pain) were used to evaluate postoperative pain level |
| postoperative Nausea and vomiting | in the first and second postoperative day | Nausea and Vomiting are recognized in frequency and time using a questionnaire. |
| Intraoperative awareness | in the first and second postoperative day | In order to record an intraoperative awareness, a semistructured interview is conducted with test questions. |
| postoperative pain Level (by CHEOPS) | in the first postoperative week (3 times a day) | CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) were used to evaluate postoperative pain level |
Countries
Switzerland
Outcome results
None listed