Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06731556
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Effects of Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol in Pediatric Tonsillectomy Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-11', 'size': 441826, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-29T16:36', 'hasProtocol': True}, {'date': '2024-12-11', 'size': 48920, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-29T16:37', 'hasProtocol': False}, {'date': '2024-12-11', 'size': 311490, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-29T16:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Wong-Baker Facial Pain Scale (Modified VAS) measurements', 'timeFrame': 'Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).', 'description': 'It is an adapted version for children. Pain is graded on the basis of different facial expressions (happy face → crying face). A happy face means no pain, while a crying face means a lot of pain.'}], 'primaryOutcomes': [{'measure': "Children's Hospital of Eastern Ontario Pain Scale measurements", 'timeFrame': 'Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).', 'description': 'CHEOPS consists of a total of 6 categories of behaviour, with specific score ranges for each. The total score ranges from 6 to 16. A score of 16 means a lot of pain, while 4 means no pain.'}], 'secondaryOutcomes': [{'measure': 'VISUAL ANALOGUE Scale measurements', 'timeFrame': 'Pain levels were assessed at predefined time points (15, 30, 60, 120 minutes, and 2, 4, 6, 12 hours after surgery).', 'description': "The patient indicates the level of pain by marking it on a visual scale, with one end of the line labelled 'No Pain' (0) and the other end labelled 'Intolerable Pain' (10).\n\n0: No pain at all. 1-3: Mild pain. 4-6: Moderate pain. 7-10: Severe pain."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intranasal Spray', 'intranasal Analgesia', 'Diclofenac Sodium', 'Ibuprofen', 'Paracetamol', 'Tonsillectomy'], 'conditions': ['Tonsil Disease', 'Pain Management', 'Intranasal Drug Administration']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy and safety of intranasal Diclofenac Sodium, intranasal Ibuprofen, and intranasal Paracetamol for pain control following tonsillectomy in pediatric patients.', 'detailedDescription': "Postoperative pain management in pediatric tonsillectomy remains a challenge, with concerns about the safety and efficacy of available analgesic options. Intranasal administration of nonsteroidal anti-inflammatory drugs presents a promising alternative for effective pain relief with minimal side effects.\n\nThis prospective, randomized study evaluated the efficacy and safety of intranasal diclofenac sodium, intranasal ibuprofen, and intranasal paracetamol compared to intravenous paracetamol in pediatric patients following tonsillectomy. Sixty patients, aged 2 to 14 years, were divided into four groups to receive either intranasal paracetamol (Group 1), intranasal diclofenac sodium (Group 2), intranasal ibuprofen (Group 3), or intravenous paracetamol (Group 4). Pain was assessed using the CHEOPS, VAS, and Wong-Baker modified VAS scoring systems at various postoperative time points. Statistical analysis was performed using the Kruskal-Wallis and Dunn's tests."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Pediatric patients who have undergone a tonsillectomy.\n\nExclusion Criteria:\n\n* Chronic sinusitis\n* Common cold or rhinitis\n* Turbinate hypertrophy\n* Nasal polyposis\n* Deviated nasal septum\n* Impaired mucociliary clearance\n* Atrophic rhinitis'}, 'identificationModule': {'nctId': 'NCT06731556', 'briefTitle': 'Analgesic Effects of Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol in Pediatric Tonsillectomy Cases', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol for Pain Relief After Pediatric Tonsillectomy', 'orgStudyIdInfo': {'id': '20.08.2021-E.28962'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Paracetamol', 'description': 'Participants in this arm received intranasal paracetamol (1.25 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.', 'interventionNames': ['Drug: Intranasal Paracetamol']}, {'type': 'EXPERIMENTAL', 'label': 'Intranasal Diclofenac Sodium', 'description': 'Participants in this arm received intranasal diclofenac sodium (0.0625 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.', 'interventionNames': ['Drug: Intranasal Diclofenac Sodium']}, {'type': 'EXPERIMENTAL', 'label': 'Intranasal Ibuprofen', 'description': 'Participants in this arm received intranasal ibuprofen (0.375 mg/mL) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.', 'interventionNames': ['Drug: Intranasal Ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous Paracetamol', 'description': 'Participants in this arm received intravenous paracetamol (20 mg/kg/day, twice daily) for postoperative pain control. Pain levels were assessed using the Modified CHEOPS scale and the Wong-Baker VAS for children aged 4-8 years, and the standard VAS for children aged 9-15 years. Assessments were performed at 15, 30, 60, 120 minutes, and 2, 4, 6, and 12 hours post-surgery.', 'interventionNames': ['Drug: Intravenous paracetamol']}], 'interventions': [{'name': 'Intravenous paracetamol', 'type': 'DRUG', 'otherNames': ['intravenous paracetamol (Group 4)'], 'description': 'Paracetamol was administered intravenously at a dose of 20 mg/kg/day, twice daily.', 'armGroupLabels': ['Intravenous Paracetamol']}, {'name': 'Intranasal Paracetamol', 'type': 'DRUG', 'description': 'Paracetamol at a concentration of 1.25 mg/mL was administered intranasally.', 'armGroupLabels': ['Intranasal Paracetamol']}, {'name': 'Intranasal Diclofenac Sodium', 'type': 'DRUG', 'description': 'Diclofenac sodium at a concentration of 0.0625 mg/mL was administered intranasally.', 'armGroupLabels': ['Intranasal Diclofenac Sodium']}, {'name': 'Intranasal Ibuprofen', 'type': 'DRUG', 'description': 'Ibuprofen at a concentration of 0.375 mg/mL was administered intranasally.', 'armGroupLabels': ['Intranasal Ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Ramazan Bahadır KÜÇÜK', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'I plan to share the excel file where the results are collected and made understandable', 'accessCriteria': 'The period of completion of the study and data analysis 30 December 2024-15 January 2025'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}