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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | Children will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater. |
|
| Midazolam oral solution | Active Comparator | Children will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Emergence agitation | 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. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Bradycardia | 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. | 2 hours |
| Hypotension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel MN Guimarães, MD | University of Brasilia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Brasilia University | BrasÃlia | Federal District | 7000000 | Brazil |
Plan to share the database used for analysis, without any variable that may help to identify individuals (such as name, register), to facilitate meta-analysis and re-analysis.
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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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.
| Midazolam oral solution | Drug | Oral midazolam, 0.5mg/kg (its a 2mg/ml solution) |
|
| Oral saline | Drug | Oral saline, 0.25ml/kg |
|
|
| Nasal saline | Drug | Nasal saline 0.01ml/kg |
|
|
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. |
| 2 hours |
| Intraocular pressure | It will be measured in the first 15 minutes after the induction of general anesthesia using an ocular tonometer. It is measured in mmHg. | 15-minutes |
| Respiratory depression | 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). | 30 minutes |
| Paradoxal agitation | 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). | 30 minutes |
| 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 |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |