Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 1:29 PM
Study NCT ID:
NCT03997006
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2019-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000628', 'term': 'Aminophylline'}, {'id': 'D009388', 'term': 'Neostigmine'}, {'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013806', 'term': 'Theophylline'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D050338', 'term': 'Phenylammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2019-06-20', 'studyFirstSubmitQcDate': '2019-06-24', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median and Range of Numeric Pain Rating Scale (NPRS) score', 'timeFrame': '48 hours after initiation of treatment', 'description': 'NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, then every 12h till 48h)'}], 'secondaryOutcomes': [{'measure': 'Mean and Standard deviation of PDPH duration (hours) (mean±SD)', 'timeFrame': '48 hours after initiation of treatment', 'description': 'Time from PDPH onset till NPRS score ≤ 3'}, {'measure': 'Number of participants and Rate of Treatment-related complications', 'timeFrame': '48 hours after initiation of treatment', 'description': 'Number of participants and Rate of: Diarrhea, Palpitation, Abdominal cramps, Muscle twitches, Bronchospasm, Urinary bladder hyperactivity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aminophylline', 'Atropine', 'Neostigmine', 'Post-dural puncture headache', 'Spinal anesthesia'], 'conditions': ['Post-Dural Puncture Headache']}, 'descriptionModule': {'briefSummary': 'Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture in the treatment of post-dural puncture headache (PDPH).\n\nBackground: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.\n\nPatients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with NPRS score of ≥ 5\n* American Society of Anesthesiologists (ASA) physical status ≤ II\n* Age from 21 to 50 years\n\nExclusion Criteria:\n\n* Patients with NPRS score \\< 5\n* ASA physical status \\> II\n* Age \\< 21 years or \\> 50 years\n* Pregnant women\n* History of; chronic headache, Cluster headache, Migraine\n* History of; Convulsions, Cerebrovascular accident, Previous neurological diseases\n* Signs of meningismus\n* Bronchial asthma\n* Arrhythmia\n* Hypertension\n* Ischemic heart disease\n* Hyperthyroidism'}, 'identificationModule': {'nctId': 'NCT03997006', 'acronym': 'RCT', 'briefTitle': 'Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Damanhour Teaching Hospital'}, 'officialTitle': 'Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'DTH:19001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (n=30)', 'description': 'Aminophylline group', 'interventionNames': ['Drug: IV Aminophylline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group NA (n=30)', 'description': 'Neostigmine/Atropine group', 'interventionNames': ['Drug: IV Neostigmine Methylsulfate + Atropine Sulphate']}], 'interventions': [{'name': 'IV Aminophylline', 'type': 'DRUG', 'otherNames': ['Minophylline-N ampoule'], 'description': 'IV Aminophylline (100 mg/8h)', 'armGroupLabels': ['Group A (n=30)']}, {'name': 'IV Neostigmine Methylsulfate + Atropine Sulphate', 'type': 'DRUG', 'otherNames': ['Neostigmine ampoule, Atropine ampoule'], 'description': 'IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h', 'armGroupLabels': ['Group NA (n=30)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damanhūr', 'state': 'El-Beheira', 'country': 'Egypt', 'facility': 'Damanhour Teaching Hospital', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'overallOfficials': [{'name': 'Ahmed M Shaat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Damanhour Teaching Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour Teaching Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}