Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-03 @ 12:27 PM
Study NCT ID:
NCT05523102
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paracetamol Compared With Ketorolac for Post-operative Analgetic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}], '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': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Patient does not know what analgetics are given, investigator also do not evaluate pain therefore is masked from the intervention given'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : paracetamol group Control Group: ketorolac'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain change', 'timeFrame': 'Total 48 hours (0, 8, 12, 24 and 48 hours) post operation', 'description': 'Post operative analgesic assessment using rFLACC: a pain scoring used primarily for unconscious or disabled children. 0 no pain at all, 10: worst pain (range 0 - 10) Grading is based on the clinical and subjective signs defined in the scoring. For the purposes of this study "adequate pain relief" was defined as achieving a pain score of four or less.'}], 'secondaryOutcomes': [{'measure': 'Change in Opioid usage', 'timeFrame': '48 hours post operatively', 'description': 'Change in opioid administration as an opioid analgesic'}, {'measure': 'Adverse effects', 'timeFrame': '48 hours post operatively', 'description': 'Increase of ALT/AST 3 times above normal range, AKI risk stage, gastrointestinal bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acetaminophen', 'Ketorolac', 'Postoperative pain', 'Pediatric', 'NSAID', 'Paracetamol', 'Opioid', 'Morphine'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Post-operative analgetic modalities vary between center to center, especially in Indonesia. Considerations include potency/effectivity of the analgetics to achieve adequate pain control as soon as possible, reducing the total opioid dose intake and overall reducing potential opioid adverse effects. NSAID have been known to have more adverse effects than acetaminophen (paracetamol) but offers a higher potency for analgetic effects. Here the investigators compare whether paracetamol is adequate as a post-operative analgetics and confers fewer overall adverse effects when compared with ketorolac (NSAID)', 'detailedDescription': 'OBJECTIVE: The purpose of this study was to compare the efficacy of Ketorolac versus Paracetamol as an adjunct to Nalbuphine in the management of post-operative pain following elective cardiac surgery.\n\nSTUDY DESIGN: Randomized (single-blind) control trial.\n\nSAMPLING TECHNIQUE: Computer generated, randomized selection of patients with 50% probability of assignment into either group.\n\nPLACE AND STUDY DURATION: (single center) PICU and Neurosurgery HCU at the Cipto Mangunkusumo National Referral Center Hospital, Jakarat, Indonesia, over a period of 6 months, from March to August 2022.\n\nMETHODS: Eighty-five patients (46 in paracetamol group and 39 in ketorolac group) were randomly assigned to receive either Paracetamol (treatment) or Ketorolac (control), along with the usual pre and intraoperative sedative/analgetics, and opioid as indicated over the first 48 hours postoperatively. The treatment group received injection Paracetamol 15mg/kg six hourly, whereas control group received injection Ketorolac 0.5mg/kg eight hourly.\n\nPRIMARY OUTCOME: The rFLACC (pain score) was evaluated at 0, 8, 12, 24 and 48 hours post-operation and a score of 4 or less was taken as a cut-off for adequate pain control.\n\nSECONDARY OUTCOMES: The total dose of opioid administered to each patient and adverse effects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postoperative patients admitted to Neurosurgery HCU or PICU\n* Parents/guardian signed informed consent forms\n\nExclusion Criteria:\n\n* History of allergy to paracetamol and ketorolac\n* Administration of opioid 24 hours before surgery\n* Liver dysfunction\n* Renal failure'}, 'identificationModule': {'nctId': 'NCT05523102', 'briefTitle': 'Paracetamol Compared With Ketorolac for Post-operative Analgetic', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Evaluation of Paracetamol as Post-operative Analgetic Modality Compared With Ketorolac', 'orgStudyIdInfo': {'id': '0254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paracetamol', 'description': 'Paracetamol 15mg/kg 6 hourly for 48 hours post-operatively', 'interventionNames': ['Drug: Paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketorolac', 'description': 'Ketorolac 0.5mg/kg 8 hourly for 48 hours post-operatively', 'interventionNames': ['Drug: Ketorolac']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'otherNames': ['Acetaminophen'], 'description': 'Intravenous paracetamol/acetaminophen', 'armGroupLabels': ['Paracetamol']}, {'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['NSAID'], 'description': 'Intravenous ketorolac/NSAID', 'armGroupLabels': ['Ketorolac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Rismala Dewi, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}, {'name': 'Bernie E Medise, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatrics Resident, Principal Investigator', 'investigatorFullName': 'Radhian Amandito', 'investigatorAffiliation': 'Indonesia University'}}}}