Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT05928520
Status:
UNKNOWN
Last Update Posted:
2023-07-11
First Post:
2023-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain Management in Pediatric Adenotonsillectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-09', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-22', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified visual analogue pain score (m-VAS)', 'timeFrame': '"day 7" after surgery', 'description': 'It is 0-10 scale, color-coded (blue to red) scale. The scale also included depictions of faces, from happy to sad. Zero indicates no pain, 1-3 indicates mild pain, 4-7 indicates moderate pain, and 8-10 indicates severe agony.'}], 'secondaryOutcomes': [{'measure': 'Post-tonsillectomy bleeding', 'timeFrame': 'Within 7 days after surgery', 'description': 'Percentage of cases'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'Within 7 days after surgery', 'description': 'Percentage of cases'}, {'measure': 'Halitosis', 'timeFrame': 'Within 7 days after surgery', 'description': 'Percentage of cases'}, {'measure': 'Otalgia', 'timeFrame': 'Within 7 days after surgery', 'description': 'Percentage of cases'}, {'measure': 'Fever', 'timeFrame': 'Within 7 days after surgery', 'description': 'Percentage of cases'}, {'measure': 'Trismus', 'timeFrame': 'Within 7 days after surgery', 'description': 'Percentage of cases'}, {'measure': 'Time to first ibuprofen rescue analgesia', 'timeFrame': 'Within 7 days after surgery', 'description': 'The time from the end of the surgical procedure to the first request of ibuprofen in minutes'}, {'measure': 'Time to first oral fluid intake', 'timeFrame': 'Within the first day after surgery', 'description': 'It is measured in hours, beginning from the end of the procedure'}, {'measure': 'Time to first oral solid intake', 'timeFrame': 'Within the first day after surgery', 'description': 'It is measured in hours, beginning from the end of the surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Topical analgesia', 'Lidocaine', 'Tramadol', 'Modified Visual Analogue Scale'], 'conditions': ['Pain Management']}, 'referencesModule': {'references': [{'pmid': '30921525', 'type': 'BACKGROUND', 'citation': 'Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update)-Executive Summary. Otolaryngol Head Neck Surg. 2019 Feb;160(2):187-205. doi: 10.1177/0194599818807917.'}, {'pmid': '33201518', 'type': 'BACKGROUND', 'citation': 'Aldamluji N, Burgess A, Pogatzki-Zahn E, Raeder J, Beloeil H; PROSPECT Working Group collaborators*. PROSPECT guideline for tonsillectomy: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Jul;76(7):947-961. doi: 10.1111/anae.15299. Epub 2020 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'Tonsillectomy is considered one of the most frequent minor surgeries conducted on a day-case basis on children, and usually associated with pain and sore throat. This study aimed to include 80 children, ASA physical status I\\&II aged 4-15 years, and undergoing tonsillectomy. The purpose of this study is to determine the analgesic efficacy of topically applied lidocaine and tramadol in relieving post-operative pain in children following tonsillectomy.', 'detailedDescription': 'Pain and sore throat following tonsillectomy are typical. As a result, the issue of adequate post-tonsillectomy pain management remains a significant therapeutic obstacle. Several medications, including nonsteroidal anti-inflammatory drugs, corticosteroids and narcotics have been utilised to alleviate pain following tonsillectomy. Nevertheless, they have numerous undesirable negative consequences. NSAIDs may impede hemostasis and increase the propensity for bleeding. Opioid may result in respiratory depression, nausea, and vomiting. Consequently, the major purpose of this study is pain alleviation with minimal adverse effects.\n\nThis prospective, randomized, double-blind controlled clinical study will include 80 children, undergoing tonsillectomy, to receive either topical tramadol 5% or lidocaine 2%. Modified Visual Analogue Scale (m-VAS), bleeding, nausea, vomiting, sore throat, otalgia, fever, halitosis, and constipation will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent acute tonsillitis\n* Chronic tonsillitis\n* Tonsillar hypertrophy with or without obstructive sleep apnea\n\nExclusion Criteria:\n\n* Parent refusal\n* Hypersensitivity\n* History of bronchial asthma\n* Renal impairment\n* Impaired liver function\n* Bleeding disorders'}, 'identificationModule': {'nctId': 'NCT05928520', 'acronym': 'AZU', 'briefTitle': 'Pain Management in Pediatric Adenotonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Comparison of Analgesic Efficacy of Topical Tramadol Versus Topical Lidocaine in the Control of Post Operative Pain in Children After Tonsillectomy', 'orgStudyIdInfo': {'id': 'Alazhar University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tramadol group', 'description': 'Swabs soaked with tramadol 5% 2 mg/kg diluted with saline 0.9%', 'interventionNames': ['Drug: Tramadol 5%', 'Drug: Lidocaine 2%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine group', 'description': 'Swabs soaked with lidocaine 2% 2mg /kg diluted with saline 0.9%', 'interventionNames': ['Drug: Tramadol 5%', 'Drug: Lidocaine 2%']}], 'interventions': [{'name': 'Tramadol 5%', 'type': 'DRUG', 'otherNames': ['Topical tramadol'], 'description': 'Topical tramadol 5%', 'armGroupLabels': ['Lidocaine group', 'Tramadol group']}, {'name': 'Lidocaine 2%', 'type': 'DRUG', 'otherNames': ['Topical Lidocaine'], 'description': 'Topical Lidocaine 2%', 'armGroupLabels': ['Lidocaine group', 'Tramadol group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdelwahab Saleh, MD', 'role': 'CONTACT', 'email': 'abdelwahabsaleh11@gmail.com', 'phone': '+20 122 362 1031'}], 'overallOfficials': [{'name': 'Abdelwahab Saleh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, AlAzhar University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication and no end date.', 'ipdSharing': 'YES', 'description': 'All individual participant data will be available indefinitely following publication. Data related to the study protocol, informed consent, clinical study report and the statistical analysis plan will be available to anyone who wishes to access the data.', 'accessCriteria': 'Data will be available indefinitely following publication. Documents will be allowed for sharing through email. A third party will decide the quality and type of data requests. The criteria for reviewing requests based on the quality of the requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia, Intensive Care, and Pain Management', 'investigatorFullName': 'Abdelwahab Saleh', 'investigatorAffiliation': 'Al-Azhar University'}}}}