Pain Clinical Trial
Official title:
An Observational Study of Emergence and Hypoactive Delirium After Anesthesia
Early postoperative negative behaviour (ePONB), such as pain, emergence delirium (ED) and hypoactive delirium, is a relevant clinical problem during recovery from anesthesia. Specifically, many children often present with different forms of negative behavior namely ED, hypoactive delirium or pain. Such negative behavior differs in terms of evolution, treatment, prognosis and clinical implications. Furthermore, there is overlap between tools used to measurement postoperative pain and ED. As a result, the assessment of the different forms of negative behavior are often compromised by the presence of postoperative pain. Therefore, the application of scales used to measure negative behaviour in postanesthetic, non-surgical patients aged 3 years and under scheduled for elective MRI may clarify the presence of ED, hypoactive delirium and pain. An improved understating of postanesthetic negative behavior is important in order to help implement appropriate measures so as to better treat these patients.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 2023 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 3 Years |
Eligibility | Inclusion Criteria: - Children = 3 years old, scheduled for elective MRI. - Patients whose parents are fluent in French or English. Exclusion Criteria: - Intubated patients or have higher oxygen requirements - Parent/guardian refusal As this study will be conducted with only one NIPE monitor, and it will be devoted to the patient for about 1 hours, two consecutive patients cannot be enrolled in the study. In this case, the second patient will be considered eligible but excluded, and data will not be collected. |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Children's Hospital | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-anesthesia negative behaviors (pain, emergence delirium and hypoactive delirium) | Validation of NIPE as a tool to predict and assess post-anesthesia negative behaviors. | 1 hour |
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