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Institution decided on starting a new protocol of sedation, with another methods and that´s why this study has not started.
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Thousands of children receive sedation for diagnostic and therapeutic interventions annually, and this number is expected to increase. Children are at higher risk for sedation-related complications than adults. In different scenarios, multiple drugs are used to achieve sedation, each one with particular adverse events that must be monitored and reported.
Children that need CT scans for traumatic brain injuries often need sedation, without needing and IV line for that. Chloral hydrate is an hypnotic agent used since 1832 with low incidence of adverse events; however, despite its worldwide use, it's being abandoned due to bitter taste, long time of sedation onset, vomiting and mild sedation. Intranasal midazolam, on the other hand, produces high and fast concentrations on CSF with greater rates of success but probably with higher adverse events. There are no prospective studies with large series of patients using intranasal midazolam.
The aim of this study is to determine if nasal midazolam is a safer approach and more effective sedative regimen when compared to rectal chloral hydrate to children undergoing CT scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chloral hydrate | Active Comparator | Children undergoing CT scanning will receive in this arm 50 mg per kg of rectal chloral hydrate. |
|
| Midazolam | Active Comparator | Children undergoing CT scanning will receive in this arm 0,4 mg/kg of nasal midazolam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | 0,4 mg per kg - intranasal midazolam - once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Such as hypoxemia, respiratory depression, vomiting, hypotension | Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of both drugs | Patients vital signs and adverse events will be monitored through patient stay in the emergency department. Mean time after sedation is about three hours. Variables collected include Ramsay score for sedation. To consider hospital discharge, we will try to validate Aldrette score and compare the scores between the two arms. Mean time to onset of sedation and time of emergency department stay will also be compared as a mark of efficacy of these two drugs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Mekitarian Filho, MSc | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo | São Paulo | São Paulo | 05508000 | Brazil |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D002697 | Chloral Hydrate |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Chloral Hydrate |
| Drug |
50 mg per kg, rectal |
|
| Participants will be followed for the duration of hospital (emergency department) stay, an expected average of 2-3 hours |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |