Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-24 @ 4:11 AM
Study NCT ID:
NCT00528658
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2007-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017695', 'term': 'Soft Tissue Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}], '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': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 782}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2007-09-11', 'studyFirstSubmitQcDate': '2007-09-11', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analgesic efficacy both at rest and with movement', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Soft Tissue Injuries'], 'conditions': ['Soft Tissue Injuries']}, 'referencesModule': {'references': [{'pmid': '29408866', 'type': 'DERIVED', 'citation': 'Hung KKC, Graham CA, Lo RSL, Leung YK, Leung LY, Man SY, Woo WK, Cattermole GN, Rainer TH. Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial. PLoS One. 2018 Feb 6;13(2):e0192043. doi: 10.1371/journal.pone.0192043. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are commonly used oral analgesics in emergency departments (ED) not only in Hong Kong but throughout the world. There are no large-scale (n\\>100), prospective, randomised studies comparing paracetamol with ibuprofen in the management of acute soft tissue injury.\n\nAs paracetamol is cheaper than most NSAIDs, may be as effective in the management of acute pain and possibly with fewer adverse effects, a large-scale, randomised, controlled trial is needed to answer questions of relative analgesic efficacy, safety and cost-effectiveness. Previous comparative studies on NSAIDS have been done in this unit and have suggested equivalence between two NSAIDs and paracetamol, but numbers were small and drug doses were modest.\n\nObjective: To compare the efficacy, safety and cost between oral ibuprofen and paracetamol in pain control for acute soft tissue injuries in an ED setting\n\nDesign: Prospective, double-blind, randomised controlled trial with three arms: oral paracetamol with placebo; oral ibuprofen with placebo; paracetamol and ibuprofen in combination\n\nParticipants: 783 subjects having sustained isolated soft tissue limb injury without significant fracture presenting to the ED of Prince of Wales Hospital\n\nMain outcome measures: Pain relief profiles of paracetamol, ibuprofen and the combination of both; adverse effect profiles of paracetamol, ibuprofen and the combination of both; overall cost effectiveness of paracetamol, ibuprofen and the combination of both from the perspective of the healthcare provider'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients \\>16 years presenting to the ED with isolated soft tissue injury without significant fracture\n* between 9am to 5pm, Monday to Friday,\n\nExclusion Criteria:\n\n* History of :\n\n * peptic ulceration or hemorrhage\n * recent anticoagulation\n * pregnancy\n * adverse reaction to paracetamol or ibuprofen\n * renal or cardiac failure\n * hepatic problems\n * rectal bleeding\n * chronic NSAID consumption\n * asthma\n * chronic obstructive pulmonary disease\n * chronic pain syndromes\n * prior treatment with analgesia for the same injury\n * physical, visual or cognitive impairment making use of the visual analogue scale unreliable'}, 'identificationModule': {'nctId': 'NCT00528658', 'briefTitle': 'Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Cost-effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-blind, Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'HKCEM06-07/DG2041095'}, 'secondaryIdInfos': [{'id': 'HKCEM Grant 2006-07'}, {'id': 'CUHK DG 2041095'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Paracetamol', 'Drug: Ibuprofen placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Ibuprofen', 'Drug: Paracetamol Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: Paracetamol', 'Drug: Ibuprofen']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'description': '1g qid', 'armGroupLabels': ['1', '3']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': '400mg tid', 'armGroupLabels': ['2', '3']}, {'name': 'Paracetamol Placebo', 'type': 'DRUG', 'description': 'equivalent to 1g qid', 'armGroupLabels': ['2']}, {'name': 'Ibuprofen placebo', 'type': 'DRUG', 'description': 'Equivalent to 400mg tid', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'state': 'NT', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Colin A Graham', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hong Kong Academy of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Colin Graham', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}