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This study is to be carried out to compare nebulized and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatrics.
This study is to be carried out to compare nebulized midazolam and oral midazolam in achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam administration in pediatric surgical patients.
In Pediatric Specialized Hospital, Cairo University 72 pediatric patients scheduled for undergoing general or uro-surgical operations under general anesthesia will be included in this double-blinded study. Patients will be randomly assigned into two equal groups, each group including 36 patients. In one group 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice (orally) 30 min before undergoing general anesthesia. In the other group 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing GA.
level of sedation will be compared between both groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nebulized midazolam group | Active Comparator | 36 children will receive nebulized midazolam 0.2 mg/kg in 3 ml normal saline plus 5 ml clear juice 30 min before undergoing general anesthesia |
|
| oral midazolam group | Active Comparator | 36 children will receive oral midazolam 0.5 mg/kg in 5 ml clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam nebulized | Drug | midazolam nebulized |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time required to reach a satisfactory level of sedation | time to reach ramsay sedation score 4 | from time of applying the nebulizer until 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of method of administration of midazolam by a grading system | Facemask acceptance will be graded as poor (terrified, crying, and combative),fair (moderate fear of mask not calmed with reassurance),good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily). | from time of giving midazolam oral or nebulized till 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine Cairo university | Cairo | Egypt |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Midazolam oral solution | Drug | midazolam given oral |
|
|
| Ease of separation from parents | using ease of separation and induction scoring system:
| from 30 minutes after receiving midazolam till transfer to operating room |
| acceptability of Face mask by grading systen | Facemask acceptance was graded as poor (terrified, crying, and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured), or excellent (unafraid, cooperative, and accepts mask readily) | from time of applying face mask till time of getting asleep at 1 minute intervals |
| Recovery time | time to recover | time from discontinuation of anesthesia until regaining baseline sedation score at 5 minute intervals |
| Changes in mean arterial blood pressure | Changes in mean arterial blood pressure measured in mmHg | from start of sedation till 1 hour postoperative at 5 minute intervals |
| changes in oxygen saturation | changes in oxygen saturation | from start of sedation till 1 hour postoperative at 5 minute intervals |
| changes in heart rate | changes in heart rate changes in heart rate (beats per minute) | from start of sedation till 1 hour postoperative at 5 minute intervals |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |