Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-04 @ 12:13 PM
Study NCT ID:
NCT07110051
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nalbuphine Versus Tramadol on Post Operative Analgesia in Abdominal Surgery on Pediatric Cancer Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009266', 'term': 'Nalbuphine'}, {'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to first rescue analgesia', 'timeFrame': '72 hours', 'description': 'Time to first analgesic request( paracetamol)'}], 'secondaryOutcomes': [{'measure': 'Frequency of paracetamol consumption', 'timeFrame': '72 hours', 'description': 'Postoperative paracetamol frequency'}, {'measure': 'Wong-barker faces pain rating scale score', 'timeFrame': '72 hours', 'description': 'Wong-barker faces pain rating scale score will be measured every 8 hours. The Wong-Baker Faces Pain Rating Scale is a tool that uses a combination of faces, numbers, and words to help a person effectively communicate the severity of their physical pain.\n\nThe scale starts at 0 and ends at 10, with the numbers increasing in intervals of 2. Each number relates to both a face and a small descriptive phrase. It is flexible because if someone uses the numbers, they may not need the faces or the wording. The phrase relating to each numerical value is as follows:\n\n0: no hurt or pain, 2: it hurts a little bit,4: it hurts a little more ,6: it hurts even more,8: it hurts a whole lot 10: it hurts the worst'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tramadol', 'Nalbuphine', 'Abdominal Surgeries', 'Pediatric Cancer']}, 'descriptionModule': {'briefSummary': 'In current study the investigators aim to compare between nalbuphine versus tramadol for post-operative pain control in abdominal surgeries in pediatric.', 'detailedDescription': 'Pain is an important and complex protective phenomenon. Good postoperative pain relief is important as it alleviates patient distress and aids a rapid, uncomplicated recovery.\n\nNalbuphine is a semi-synthetic opioid analgesic that belongs to the phenanthrene family. It is commonly used for pain management in children, but is associated with certain side effects such as respiratory and central nervous system depression, emesis, and pruritus due to its effect on µ2 receptors. Tramadol is a potent analgesic that binds to µ1 and µ2 receptors and enhances the inhibitory action of descending pain pathways. In contrast to other opioids, including nalbuphine, tramadol does not induce tolerance and is associated with reduced adverse effects.\n\nTherefore, in this study, investigators will compare the efficacy of nalbuphine and tramadol for the management of postoperative pain in cancer children after abdominal surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will be children aged 3-12 years\n* American society of anesthesia (ASA) classification I-III.\n* scheduled for elective Abdominal surgery under general anesthesia\n\nExclusion Criteria:\n\n* child guardian refusal.\n* Allergy from Tramal or nalbuphine\n* Patient with previous chronic pain on opioids'}, 'identificationModule': {'nctId': 'NCT07110051', 'briefTitle': 'Nalbuphine Versus Tramadol on Post Operative Analgesia in Abdominal Surgery on Pediatric Cancer Patient', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Comparative Study Between Nalbuphine Versus Tramadol on Post Operative Analgesia in Abdominal Surgery on Pediatric Cancer Patient', 'orgStudyIdInfo': {'id': 'AP2403-301-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nalbuphine (group A)', 'description': 'group A (nalbuphine) will receive a single dose of nalbuphine (0.2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours)', 'interventionNames': ['Drug: Nalbuphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol (group B)', 'description': 'group B( Tramadol) will receive a single dose of tramadol (2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours).', 'interventionNames': ['Drug: Tramadol']}], 'interventions': [{'name': 'Nalbuphine', 'type': 'DRUG', 'otherNames': ['nalufin'], 'description': 'this group will a single dose of nalbuphine (0.2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours)', 'armGroupLabels': ['nalbuphine (group A)']}, {'name': 'Tramadol', 'type': 'DRUG', 'otherNames': ['tramal'], 'description': 'this group will receive a single dose of tramadol (2 mg/kg) immediately after surgery to be repeated every 8 hours for the duration of the study (72 hours).', 'armGroupLabels': ['Tramadol (group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11769', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'National cancer institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Norma Osama AbdAllah Zayed, MD', 'role': 'CONTACT', 'email': 'norma.osama@nci.cu.edu.eg', 'phone': '01067843111'}], 'overallOfficials': [{'name': 'Reham mohamed gamal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for 6 months', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for 6 months', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, Surgical ICU and Pain Management, National Cancer Institute, Cairo University', 'investigatorFullName': 'Norma Osama Abdalla Zayed', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}