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This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.
Adenotonsillectomy is one of the most commonly performed surgical procedures in children with high incidence of emergence agitation about 80% and high degree of post operative pain.
Oral midazolam, a short-acting benzodiazepine, is commonly used as a standard premedication in children due to its well-established anxiolytic, sedative, and amnestic effects. It works by enhancing GABAergic neurotransmission in the central nervous system, helping reduce anxiety and facilitating a smoother anesthetic induction and emergence.
Dexmedetomidine is a centrally acting ฮฑ-2 adrenergic agonist with sedative, hypnotic, analgesic, anxiolytic, anti-sialagogue, antinociceptive and sympatholytic action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C (Control Group) | Active Comparator | Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice. |
|
| Melatonin Group | Experimental | Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup. |
|
| Dexmedetomidine Group | Experimental | Participants will receive placebo syrup (Apple Juice) and 2 ยต/kg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Emergence agitation | Emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED). The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable score is 20. A score of โฅ10 has 64% sensitivity and 86% specificity for the diagnosis of Emergence Agitation (ED). A score of >12 has 100% sensitivity and 94.5% specificity for the diagnosis of ED. | 30 minutes after recovery |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative anxiety | Perioperative anxiety which will be measured by using Parental separation anxiety scale (PSAS). PSAS scale:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amany A Eid, MSc | Contact | 00201012301802 | amany.kamel@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Oral melatonin syrup | Drug | Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup. |
|
| Nebulized dexmedetomidine | Drug | Participants will receive placebo syrup (Apple Juice) and 2 ยต/kg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml. |
|
| During transferring to operating room (Up to 30 minutes). |
| Mask tolerance | Mask tolerance which will be measured by using mask acceptance scale (MAS). MAS score:
| Intraoperatively |
| Degree of pain | Postoperative pain control will be assessed using Face, Legs, Activity, Cry, Consolability (FLACC) ) on arrival to PACU, 30 minutes, one hour, two hours after surgery and before home discharge. Each category is scored on the 0-2 scale, which results in a total score of 0-10.
| Before home discharge (Up to 6 hours) |
| Total postoperative analgesics consumption | Total postoperative analgesics consumption will be recorded. | Before home discharge (Up to 6 hours) |
| 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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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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