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NCT Number: NCT04292457

Namsos Anaesthesia Children Outcome Study

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.

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Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Namsos Hospital, Nord-Trondelag Hospital Trust, Namsos, Trøndelag, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Anesthesia is maintained with a continuous infusion of Propofol. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.

Sevoflurane

Drug

Anesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.

Primary outcomes

  1. Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10

    Time frame: 1 hour

    A PAED score ≥ 10 during the first hour after emergence from anaesthesia is defined as an ED event occuring

Secondary outcomes

  1. Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4

    Time frame: 1 hour

    A FLACC score ≥ 4 during the first hour after emergence from anaesthesia is defined as moderate or severe pain

  2. Post Hospital Behavioral Questionnaire (PHBQ)

    Time frame: 7 days

    An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change

  3. Post Hospital Behavioral Questionnaire (PHBQ)

    Time frame: 30 days

    An average score > 3 in one or more of the questionnaire categories is defined as postoperative behavioural change

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Collaborators

  • St. Olavs Hospital
  • ØNH Legen Trondheim

Registry information

Official study title

Namsos Anaesthesia Children Outcome Study (NACOS)

Acronym: NACOS

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 3, 2020
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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