Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:28 AM
Study NCT ID:
NCT07435493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FLACC Scale (face, legs, activity, cry, consolability)', 'timeFrame': 'at 0 hours, 2hours, and 6 hours postoperatively', 'description': 'It grades pain from 0 to 10 by observing five categories-Face, Legs, Activity, Cry, and Consolability-with each item scored 0-2.'}], 'secondaryOutcomes': [{'measure': 'Time to oral intake', 'timeFrame': '6 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid', 'Fentanyl', 'obstructive sleep apnea', 'adenotonsillectomy'], 'conditions': ['Adenotonsillectomy', 'Obstructive Sleep Apnea (OSA)', 'Fentanyl', 'Opioid']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSince 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%.\n\nAdenotonsillectomy 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.\n\nFentanyl 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.\n\nA 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 \\<or= 10) undergoing adenotonsillectomy, while minimizing the risks associated with opioid use.\n\nThe purpose of this study is to emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate OSA undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 5-10 years.\n* Diagnosed with mild to moderate Obstructive Sleep Apnea (apnea-hypoxia index 1-10).\n* Scheduled for elective adenotonsillectomy.\n* American Society of Anesthesiologists physical status I-II.\n\nExclusion Criteria:\n\n* Severe Obstructive Sleep Apnea (apnea-hypoxia index \\>10).\n* Known allergies to study medications.\n* Patient with predicted difficult air way (Mallampatti 3\\&4).\n* History of opioid use or chronic pain syndromes.\n* Neurological or metabolic disorders affecting pain perception.\n* Parental refusal to consent.'}, 'identificationModule': {'nctId': 'NCT07435493', 'briefTitle': 'Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'FMASU MD141/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl-Based Analgesia group', 'description': '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.', 'interventionNames': ['Drug: Group A: Fentanyl-Based Analgesia']}, {'type': 'EXPERIMENTAL', 'label': 'Opioid-Free Multimodal Analgesia group', 'description': '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.', 'interventionNames': ['Drug: Group B: Opioid-Free Multimodal Analgesia']}], 'interventions': [{'name': 'Group A: Fentanyl-Based Analgesia', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Fentanyl-Based Analgesia group']}, {'name': 'Group B: Opioid-Free Multimodal Analgesia', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Opioid-Free Multimodal Analgesia group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Anhar Falila, Assistant lecturer', 'role': 'CONTACT', 'email': 'Anhar.fathy@med.asu.edu.eg', 'phone': '01222176925'}], 'facility': 'Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Anhar Falila, Assistant Lecturer', 'role': 'CONTACT', 'email': 'Anhar.fathy@med.asu.edu.eg', 'phone': '01222176925'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'All data ill be available when it needed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in anesthesiology, faculty of medicine, Ain shams university', 'investigatorFullName': 'Anhar Fathy', 'investigatorAffiliation': 'Ain Shams University'}}}}