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Comparative study between nebulised dexmedetomidine and nebulized midazolam in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
Dexmedetomidine is widely used in children and is replacing midazolam as the drug of choice for preoperative anxiolysis and sedation. However, there are limited studies comparing nebulized route in reducing preoperative anxiety and emergence delirium in children undergoing lower abdominal surgeries
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | will receive nebulized Dexmedetomidine 3 µg/kg |
|
| Midazolam | Active Comparator | will receive nebulized Midazolam 0.3 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulised Dexmeditomidine | Drug | premedication by dexmeditomidine 3mcg/kg in children undergoing lower abdominal surgeries |
|
| Measure | Description | Time Frame |
|---|---|---|
| level of preoperative anxiety | The level of anxiety of the child during separation from parents according to Parental separation anxiety scale (PSAS), with a 4-point scale as: 1=easy separation; 2=whimpers, but is easily reassured, not clinging; 3=cries and cannot be easily reassured, but not clinging to parents and 4=crying and clinging to parents | 30 minutes after drug administration |
| Incidence of emergence delirium | Incidence of emergence delirium, wake up behaviour will be assessed according to Watcha scale where Score is observed values as follows: 0= asleep, 1=calm, 2=crying but can be consoled, 3=crying but cannot be consoled, 4=agitating and thrashing around | immediate postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| the level of sedation | The level of sedation when the child first seen in the operating room 30 minutes after sedation using Ramsey sedation scale | 30 minutes after drug administration |
| hemodynamic changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ainshams University | Cairo | 0000 | Egypt |
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| Nebulised Midazolam | Drug | premedication by nebulised midazolam 0.3mg/kg in children undergoing lower abdominal surgeries |
|
|
number of participants experienced any hemodynamic changes if more than 20% change in mean arterial pressure (MAP) and Heart Rate (HR).
| perioperative |
| PONV | Incidence of post-operative nausea and vomiting. | perioperative |
| recovery time | Recovery time, time between laryngeal mask removal and discharge from recovery room. | up to 2 hours postoperative |
| total fentanyl use | Total fentanyl use during operation | intraoperative |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| 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 |
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