Namsos Anaesthesia Children Outcome Study

Study Overview
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Brief Summary
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Behavioral disturbances are often seen in children after anesthesia both immediately after surgery (emergence delirium) and after discharge from hospital. Persisting behavioral changes may affect emotional and cognitive development. It is known that both type of surgery and anesthetic management affect the occurrence of behavioral disturbances. Specifically, differences in occurrence were found after sevoflurane anesthesia and propofol anesthesia, two anesthetics that are generally used in practice. However, evidence is based on methodologically weak studies. The described occurrence of behavioral disturbances in children after anesthesia is not in line with the investigators' clinical experience, and neither are the described differences in occurrence between sevoflurane anesthesia and propofol anesthesia. This study will compare emergence delirium and behavioral changes after discharge from hospital in children who had surgery for removal of their tonsils under sevoflurane anesthesia versus propofol anesthesia.

Official Title
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Namsos Anaesthesia Children Outcome Study (NACOS)

Conditions
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Emergence Delirium

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adenotomy and/or tonsillotomy and/or tonsillectomy ASA physical status class I or II Exclusion Criteria: unexperienced ear-nose-throat (ENT) surgeon (ENT surgeon < 1 year of training, ENT surgeon without experience with the use of laryngeal mask as airway during adenotomy/tonsillotomy/tonsillectomy) preoperative syndromes ASA physical status class > 2 missing written consent from parents/guardians

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>Anesthesia is maintained with Propofol | Drug: Propofol<br>* Anesthesia is maintained with a continuous infusion of Propofol. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.<br>|
| Experimental: Sevoflurane<br>Anesthesia is maintained with Sevoflurane | Drug: Sevoflurane<br>* Anesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10 | A PAED score ≥ 10 during the first hour after emergence from anaesthesia is defined as an ED event occuring | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4 | A FLACC score ≥ 4 during the first hour after emergence from anaesthesia is defined as moderate or severe pain | 1 hour | 
| Post Hospital Behavioral Questionnaire (PHBQ) | An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change | 7 days | 
| Post Hospital Behavioral Questionnaire (PHBQ) | An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sevoflurane, Pediatric Anaesthesia, Emergence Delirium, Postoperative Behavioral Changes, Propofol, Adenotonsillectomy