Emergence Delirium
Conditions
Keywords
Emergence Delirium, Emergence Agitation, premedication, dexmedetomidine, midazolam
Brief summary
Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality.
Detailed description
Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.
Interventions
DRUGDexmedetomidine
Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution)
Oral midazolam, 0.5mg/kg (its a 2mg/ml solution)
DRUGOral saline
Oral saline, 0.25ml/kg
DRUGNasal saline
Nasal saline 0.01ml/kg
Sponsors
Brasilia University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will not know which group they will be allocated. The anesthesia care provider will not know which premedication the patient received because another professional, who is not from the research team, will provide it to the child. The investigator and outcome assessor will only know the allocated group latter by a code which will be revealed after the end of the analysis.
Intervention model description
All participants will receive an intranasal and an oral drug. One group will receive oral midazolam and intranasal saline, the other will receive oral saline and intranasal dexmededomedine.
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for amygdalectomy * American Society of Anesthesiologists Physical Status PI or PII * Absence of congenital neuropathy * Absence of cardiac pathology (any) * Intolerance to one of the studied drugs.
Exclusion criteria
* Protocol violation * Need to transfer for ICU intubated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence agitation | 15 minutes | Anesthesiologist provider's reported score on PAED (Paediatric Anesthesia Emergence Scale) during the first 15 minutes after the extubation. The PAED consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bradycardia | 2 hours | It is defined as a heart rate lower than the expected for the age or a drop higher than 30% of the patient's lowest previous heart rate registered. It will be measured using pletysmography and ECG beat-by-beat during the surgery and it will be true if it occurs at least once. |
| Hypotension | 2 hours | It is defined as a mean arterial pressure lower than the expected for the age or a drop higher than 30% of the patient's lowest previous mean arterial pressure registered. It will be measured using oscillatory method every 5 minutes during the surgery and it will be true if it occurs at least once. |
| Intraocular pressure | 15-minutes | It will be measured in the first 15 minutes after the induction of general anesthesia using an ocular tonometer. It is measured in mmHg. |
| Respiratory depression | 30 minutes | Anesthesiologist provider's reported incidence respiratory depression in the child, before induction of general anesthesia. It will be true if the respiratory rate is slow for the age and the variable is dichotomic (true or false). |
| Paradoxal agitation | 30 minutes | Anesthesiologist provider's reported incidence paradoxal agitation in the child, before induction of general anesthesia. The assessment subjective and the variable is dichotomic (true or false). |
Countries
Brazil
Outcome results
None listed