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Emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate Obstructive Sleep Apnea undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.
Obstructive Sleep Apnea in pediatrics is a sleep disorder characterized by repeated episodes of partial or complete upper airway obstruction during sleep, leading to disrupted breathing, poor sleep quality, and potential developmental and health issues.
Since adeno-tonsillar hypertrophy and enlarged tonsils & adenoids are the most common causes of pediatric Obstructive Sleep Apnea ,thus adenotonsillectomy is the first-line surgical treatment and is one of the most common pediatric surgeries that has a high success rate in resolving Obstructive Sleep Apnea symptoms with cure rate up to 80%.
Adenotonsillectomy is a common surgical procedure in pediatric patients and perioperative pain management with opioids is common and associated with side effects and risks. Consequently, analgesic strategies to reduce opioid utilization have been developed, because Obstructive Sleep Apnea patients are more sensitive to opioids.
Fentanyl has demonstrated efficacy in pediatrics for acute pain management but still has the risk of opioids induced ventilatory impairment which is very common in children with obstructive sleep apnea due to altered volume of distribution and clearance.
A multimodal analgesia approach, which combines various non-opioid medications (acetaminophen, non-steroidal anti-inflammatory drugs, dexamethasone and ketamine ) can effectively manage perioperative pain in children with mild to moderate Obstructive Sleep Apnea with (apnea hypoxia index \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl-Based Analgesia group | Experimental | Fentanyl-Based Analgesia will receive intraoperative fentanyl (1 μg/kg IV) with standard anesthetic care with postoperative rescue analgesia with acetaminophen (15 mg/kg) as needed. |
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| Opioid-Free Multimodal Analgesia group | Experimental | Opioid-Free Multimodal Analgesia will receive preoperative acetaminophen (15 mg/kg) and ibuprofen (10 mg/kg), intraoperative ketamine (0.5 mg/kg IV) and dexamethasone (0.1 mg/kg IV) with postoperative rescue analgesia with acetaminophen as needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A: Fentanyl-Based Analgesia | Drug | Fentanyl-Based Analgesia will receive intraoperative fentanyl (1 μg/kg IV) with standard anesthetic care with postoperative rescue analgesia with acetaminophen (15 mg/kg) as needed |
| Measure | Description | Time Frame |
|---|---|---|
| FLACC Scale (face, legs, activity, cry, consolability) | It grades pain from 0 to 10 by observing five categories-Face, Legs, Activity, Cry, and Consolability-with each item scored 0-2. | at 0 hours, 2hours, and 6 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time to oral intake | 6 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anhar Falila, Assistant Lecturer | Contact | 01222176925 | Anhar.fathy@med.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | Egypt |
|
All data ill be available when it needed
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| Group B: Opioid-Free Multimodal Analgesia | Drug | Opioid-Free Multimodal Analgesia will receive preoperative acetaminophen (15 mg/kg) and ibuprofen (10 mg/kg), intraoperative ketamine (0.5 mg/kg IV) and dexamethasone (0.1 mg/kg IV) with postoperative rescue analgesia with acetaminophen as needed. |
|
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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