Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT03222518
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2017-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'D010894', 'term': 'Piroxicam'}], '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': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'study medications consists of identical shape pills of each study medication randomization is made by sealed envelops and a randomly sequence generated numbers.\n\npatients and the research associate who collected the outcome data are blinded from the study group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects are randomized in 3 arms:\n\n* paracetamol group\n* NSAID group\n* paracetamol + NSAID group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2017-05-14', 'studyFirstSubmitQcDate': '2017-07-16', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'new oral analgesic medications needed rate', 'timeFrame': '3 days and 7 days', 'description': "oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition"}], 'secondaryOutcomes': [{'measure': 'the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later', 'timeFrame': '3 and 7 days', 'description': '\\[delta VNS= (VNS D0 - VNS D7 / VNS D0) x 100\\]'}, {'measure': 'The appearance of side effects', 'timeFrame': '7 days', 'description': 'The appearance of side effects: such as Drowsiness ,Decreased respiratory rate (\\<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness.\n\n• Digestive hemorrhage.'}, {'measure': 'the rate of ED readmissions for residual pain', 'timeFrame': '3 and 7 days', 'description': 'ED readmissions for residual pain'}, {'measure': "patient satisfaction assessed by Likert's verbal scale.", 'timeFrame': '3 and 7 days', 'description': "patient satisfaction assessed by Likert's verbal scale."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute pain, trauma, paracetamol, NSAID'], 'conditions': ['Acute Pain Due to Trauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\nCompare the effect of paracetamol alone against NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain.', 'detailedDescription': 'Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients even use these medications without a prescription. It is not known, however, whether or not NSAIDs have an additional value relative to paracetamol for the treatment of pain.\n\nAll patients were assigned in a 1:1:1 ratio. Randomization of subjects was performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally every 8th hour for 7 days; NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID combination who received both treatments at the same doses for 7 days. All protocol treatments were administered in opaque packets with code number according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, and findings of the clinical examination. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* acute (\\<24 hours) post traumatic pain of the extremity and requiring analgesic treatment upon discharge for pain with intensity \\>3 on a visual numeric scale\n\nExclusion criteria:\n\n* open fracture\n* head, abdominal, thoracic or polytrauma.\n* Need for hospitalization, regular use of paracetamol and NSAIDs during the two weeks before admission to ED\n* history of allergy or hypersensitivity to either paracetamol or NSAIDs,\n* contraindication to paracetamol or NSAIDs,\n* acute /history of GI hemorrhage and renal insufficiency,\n* an inability to assess pain intensity according to the VNS.\n* Pregnancy\n* heart failure\n* known hepatic cirrhosis\n* known severe renal impairment (Creatinine clearance \\<30 ml/min)\n* swallowing disorders\n* Refusal, incapacity or difficulties to consent or to communicate'}, 'identificationModule': {'nctId': 'NCT03222518', 'briefTitle': 'NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management', 'orgStudyIdInfo': {'id': 'PAR vs NSAIDs vs Comb in Pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Parcetamol Group', 'description': 'The patient receives an envelope containing Paracetamol 1000 mg at the dose of 3 times / day + follow-up sheet + appointment card.', 'interventionNames': ['Drug: NSAID', 'Drug: paracetamol-NSAID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NSAID Group', 'description': 'The patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card.', 'interventionNames': ['Drug: Paracetamol', 'Drug: paracetamol-NSAID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NSAID + Paracetamol Group', 'description': 'The patient receives an envelope containing NSAID 20 mg piroxicam at a dose of 2 times/day + Paracetamol 1000 mg at a dose of 3 times / day + follow-up sheet + appointment card.', 'interventionNames': ['Drug: Paracetamol', 'Drug: NSAID']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'description': '21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period', 'armGroupLabels': ['NSAID + Paracetamol Group', 'NSAID Group']}, {'name': 'NSAID', 'type': 'DRUG', 'otherNames': ['piroxicam'], 'description': '14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period', 'armGroupLabels': ['NSAID + Paracetamol Group', 'Parcetamol Group']}, {'name': 'paracetamol-NSAID', 'type': 'DRUG', 'otherNames': ['combination'], 'description': '21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period', 'armGroupLabels': ['NSAID Group', 'Parcetamol Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Monastir University Hospital', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Semir Nouira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}