Namsos Anaesthesia Children Outcome Study
- Registration Number
- NCT04292457
- Lead Sponsor
- Helse Nord-Trøndelag HF
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 761
- adenotomy and/or tonsillotomy and/or tonsillectomy
- ASA physical status class I or II
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol Propofol Anesthesia is maintained with Propofol Sevoflurane Sevoflurane Anesthesia is maintained with Sevoflurane
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Post Hospital Behavioral Questionnaire (PHBQ) 30 days An average score \> 3 in one or more of the questionnaire categories is defined as postoperative behavioural change
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
Trial Locations
- Locations (2)
ØNH Legen
🇳🇴Trondheim, Trøndelag, Norway
Namsos Hospital, Nord-Trondelag Hospital Trust
🇳🇴Namsos, Trøndelag, Norway