Emergence Delirium
Conditions
Keywords
Pediatric Anaesthesia, Emergence Delirium, Postoperative Behavioral Changes, Sevoflurane, Propofol, Adenotonsillectomy
Brief summary
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.
Interventions
DRUGPropofol
Anesthesia is maintained with a continuous infusion of Propofol. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
DRUGSevoflurane
Anesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
Sponsors
ØNH Legen Trondheim
St. Olavs Hospital
Helse Nord-Trøndelag HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10 | 1 hour | A PAED score ≥ 10 during the first hour after emergence from anaesthesia is defined as an ED event occuring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4 | 1 hour | A FLACC score ≥ 4 during the first hour after emergence from anaesthesia is defined as moderate or severe pain |
| Post Hospital Behavioral Questionnaire (PHBQ) | 7 days | An average score \> 3 in one or more of the questionnaire categories is defined as postoperative behavioural change |
Countries
Norway
Outcome results
None listed