Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ØNH Legen Trondheim | UNKNOWN |
| St. Olavs Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Experimental | Anesthesia is maintained with Propofol |
|
| Sevoflurane | Experimental | Anesthesia is maintained with Sevoflurane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hallvard Græslie, MD | Head of surgical Clinic, Namsos Hospital, Nord-Trondelag Hospital Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Namsos Hospital, Nord-Trondelag Hospital Trust | Namsos | Trøndelag | 7800 | Norway | ||
| ØNH Legen |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
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 |
| Trondheim |
| Trøndelag |
| Norway |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |