Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT03780556
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2018-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056844', 'term': 'Renal Colic'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C059451', 'term': 'lornoxicam'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-19', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain feeling', 'timeFrame': '0hours, 1hour,2hours,3hours,4hours after drug administration in both groups', 'description': 'We assess this through Visual analogue scale score to assess pain due to renal colic, number 10 means maximum pain feeling and 0 means no pain at all.'}, {'measure': 'No need for more analgesics', 'timeFrame': 'Registration of analgesic needed for 12h after the attack', 'description': 'Rescue analgesics administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal pain', 'lornoxicam', 'pethidine', 'emergency room', 'ketamine'], 'conditions': ['Renal Colic']}, 'descriptionModule': {'briefSummary': 'Patients with acute renal colic divided into 2 groups. Group L administered ornoxicam and Group P administered pethidine and VAS was recorded for both groups.', 'detailedDescription': 'Prospective, randomized, double blind clinical study including 120 patients with acute renal pain admitted in emergency department. They were randomly assigned to one of two groups using a computer-generated table. Group L received lornoxicam 8 mg IV plus 0.15 mg.kg-1 ketamine and Group P received pethidine 50 mg IV. Parameters were observed at baseline and after 0, 15, 30, 45 and 1 hour of drug treatment. The efficacy of the drug was measured by observing: patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue analgesia, adverse events and functional status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, who did not administer any analgesics at least within the last two hours. - -\n* Patients aged between 20-60 years.\n\nExclusion Criteria:\n\n* Patients with previous renal surgery\n* liver and renal failure\n* hypersensitivity to lornoxicam, ketamine and pethidine, history of peptic ulcer,\n* gastrointestinal bleeding and perforation,\n* hypertensive and history of cardiac diseases\n* pregnancy and lactation and\n* urine examination showing more than 5 leukocytes suggestive of pyuria.\n* patients with hyperthyroidism are excluded'}, 'identificationModule': {'nctId': 'NCT03780556', 'briefTitle': 'Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Lornoxicam With Low Dose Ketamine Versus Pethidine to Control Pain of Acute Renal Colic', 'orgStudyIdInfo': {'id': 'ASU 5418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lornixicam', 'description': 'Patients received lornoxicam 8 mg intravenous to control pain', 'interventionNames': ['Drug: Lornoxicam and mepridine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pethidine', 'description': 'Patients received pethidine 50mg intravenous to control pain', 'interventionNames': ['Drug: Lornoxicam and mepridine']}], 'interventions': [{'name': 'Lornoxicam and mepridine', 'type': 'DRUG', 'description': 'compare the effect of each to control pain', 'armGroupLabels': ['Lornixicam', 'Pethidine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'ِAin Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ayman Anis Metry', 'investigatorAffiliation': 'Ain Shams University'}}}}