Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-09 @ 11:47 PM
Study NCT ID:
NCT01858402
Status:
COMPLETED
Last Update Posted:
2013-05-21
First Post:
2013-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-12-23', 'releaseDate': '2014-12-10'}, {'resetDate': '2015-01-15', 'releaseDate': '2015-01-08'}], 'estimatedResultsFirstSubmitDate': '2014-12-10'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D004177', 'term': 'Dipyrone'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000632', 'term': 'Aminopyrine'}, {'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-20', 'studyFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2013-05-20', 'lastUpdatePostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from pain intensity until postoperative 6 hours', 'timeFrame': 'Pain intensity recorded until postoperative 6 hours', 'description': 'The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatric spinal anesthesia, paracetamol, dipyrone'], 'conditions': ['Other Acute Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '24144215', 'type': 'DERIVED', 'citation': 'Caliskan E, Sener M, Kocum A, Ozyilkan NB, Ezer SS, Aribogan A. The efficacy of intravenous paracetamol versus dipyrone for postoperative analgesia after day-case lower abdominal surgery in children with spinal anesthesia: a prospective randomized double-blind placebo-controlled study. BMC Anesthesiol. 2013 Oct 22;13(1):34. doi: 10.1186/1471-2253-13-34.'}]}, 'descriptionModule': {'briefSummary': 'We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.', 'detailedDescription': 'The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery\n\nExclusion Criteria:\n\n* increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs'}, 'identificationModule': {'nctId': 'NCT01858402', 'briefTitle': 'Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'The Efficacy of Intravenous Paracetamol Versus Dipyrone for Postoperative Analgesia After Day-case Lower Abdominal Surgery in Children With Spinal Anesthesia: a Prospective Randomized Double-blind Study', 'orgStudyIdInfo': {'id': 'KA 09/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol', 'description': '15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose', 'interventionNames': ['Drug: Paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dipyrone', 'description': '15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose', 'interventionNames': ['Drug: Dipyrone']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'otherNames': ['Parol'], 'description': '15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose', 'armGroupLabels': ['Paracetamol']}, {'name': 'Dipyrone', 'type': 'DRUG', 'otherNames': ['Metamizole'], 'description': '15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose', 'armGroupLabels': ['Dipyrone']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Esra Caliskan', 'investigatorAffiliation': 'Baskent University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-12-10', 'type': 'RELEASE'}, {'date': '2014-12-23', 'type': 'RESET'}, {'date': '2015-01-08', 'type': 'RELEASE'}, {'date': '2015-01-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Esra Caliskan, Associated Professor, Baskent University'}}}}