Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-01 @ 4:34 AM
Study NCT ID:
NCT04662567
Status:
TERMINATED
Last Update Posted:
2022-11-30
First Post:
2020-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Versus Intravenous Acetaminophen for Postoperative Pain Control
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'whyStopped': 'It was determined that the study should not continue as the study drug, Acetaminophen, could only be mixed in a solvent that would not allow the patients to be NPO prior to procedure.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-25', 'studyFirstSubmitDate': '2020-11-16', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain control', 'timeFrame': '24-48 hours', 'description': 'To compare the efficacy of oral versus IV formulation of acetaminophen for controlling perioperative pain after oocyte retrieval procedure.\n\nTo assess the pain level, Visual Analog Scale(VAS) score will be utilize with the minimum number 0 representing no pain and maximum number of 10 representing the highest imaginable pain level.'}], 'secondaryOutcomes': [{'measure': 'Duration of postoperative recovery', 'timeFrame': 'variable ~1-3 hours', 'description': 'To compare time from the end of procedure until discharge. This outcome is measured in minutes from the the time of entry to recovery room to the time when patient is leaving the facility'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oocyte retrieval', 'postoperative pain control', 'in vitro fertilization', 'tylenol'], 'conditions': ['Postoperative Pain', 'IVF']}, 'referencesModule': {'references': [{'pmid': '12044794', 'type': 'BACKGROUND', 'citation': 'Alloui A, Chassaing C, Schmidt J, Ardid D, Dubray C, Cloarec A, Eschalier A. Paracetamol exerts a spinal, tropisetron-reversible, antinociceptive effect in an inflammatory pain model in rats. Eur J Pharmacol. 2002 May 17;443(1-3):71-7. doi: 10.1016/s0014-2999(02)01578-9.'}, {'pmid': '4564318', 'type': 'BACKGROUND', 'citation': 'Flower RJ, Vane JR. Inhibition of prostaglandin synthetase in brain explains the anti-pyretic activity of paracetamol (4-acetamidophenol). Nature. 1972 Dec 15;240(5381):410-1. doi: 10.1038/240410a0. No abstract available.'}, {'pmid': '15662292', 'type': 'BACKGROUND', 'citation': 'Graham GG, Scott KF. Mechanism of action of paracetamol. Am J Ther. 2005 Jan-Feb;12(1):46-55. doi: 10.1097/00045391-200501000-00008.'}, {'pmid': '22039164', 'type': 'BACKGROUND', 'citation': 'Hinz B, Brune K. Paracetamol and cyclooxygenase inhibition: is there a cause for concern? Ann Rheum Dis. 2012 Jan;71(1):20-5. doi: 10.1136/ard.2011.200087. Epub 2011 Oct 28.'}, {'pmid': '17884974', 'type': 'BACKGROUND', 'citation': 'Hinz B, Cheremina O, Brune K. Acetaminophen (paracetamol) is a selective cyclooxygenase-2 inhibitor in man. FASEB J. 2008 Feb;22(2):383-90. doi: 10.1096/fj.07-8506com. Epub 2007 Sep 20.'}, {'pmid': '16385545', 'type': 'BACKGROUND', 'citation': 'Hinz B, Dormann H, Brune K. More pronounced inhibition of cyclooxygenase 2, increase in blood pressure, and reduction of heart rate by treatment with diclofenac compared with celecoxib and rofecoxib. Arthritis Rheum. 2006 Jan;54(1):282-91. doi: 10.1002/art.21540.'}, {'pmid': '21074742', 'type': 'BACKGROUND', 'citation': 'Jahr JS, Lee VK. Intravenous acetaminophen. Anesthesiol Clin. 2010 Dec;28(4):619-45. doi: 10.1016/j.anclin.2010.08.006.'}, {'pmid': '15790675', 'type': 'BACKGROUND', 'citation': 'Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.'}, {'pmid': '11274793', 'type': 'BACKGROUND', 'citation': 'Nakamura K, Li YQ, Kaneko T, Katoh H, Negishi M. Prostaglandin EP3 receptor protein in serotonin and catecholamine cell groups: a double immunofluorescence study in the rat brain. Neuroscience. 2001;103(3):763-75. doi: 10.1016/s0306-4522(01)00027-6.'}, {'pmid': '22652283', 'type': 'BACKGROUND', 'citation': 'Pasero C, Stannard D. The role of intravenous acetaminophen in acute pain management: a case-illustrated review. Pain Manag Nurs. 2012 Jun;13(2):107-24. doi: 10.1016/j.pmn.2012.03.002.'}, {'pmid': '17957182', 'type': 'BACKGROUND', 'citation': 'Pickering G, Esteve V, Loriot MA, Eschalier A, Dubray C. Acetaminophen reinforces descending inhibitory pain pathways. Clin Pharmacol Ther. 2008 Jul;84(1):47-51. doi: 10.1038/sj.clpt.6100403. Epub 2007 Oct 24.'}, {'pmid': '16580905', 'type': 'BACKGROUND', 'citation': 'Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen', 'detailedDescription': "Oocyte retrieval is an outpatient procedure that is a routine surgical intervention in the process of assisted reproductive technologies and oocyte banking. The perioperative pain control is achieved with multidrug regimen including intraoperative opioid medication and perioperative administration of oral or intravenous acetaminophen. This medication is more commonly known as Tylenol. Intravenous formulation of this medication is several fold more expensive and the data for perioperative pain control is mixed on the equivalence of pain control with intravenous versus oral acetaminophen in other fields. Currently there is no accepted standard of care and the two formulations are used interchangeably depending on primary physician's preference. We are conducting an equivalence placebo controlled randomized clinical trial to assess the difference in efficacy of these two formulations"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Female, aged 18-45\n4. Ability to take oral medication and be willing to adhere to the study intervention regimen\n\nExclusion Criteria:\n\n1. Known clinically significant liver disfunction\n2. Known allergic reactions to components of acetaminophen such as angioedema, anaphylaxis or other\n3. Known current substance use disorder\n4. Chronic pain syndrome\n5. Weight less than 50 kg'}, 'identificationModule': {'nctId': 'NCT04662567', 'briefTitle': 'Oral Versus Intravenous Acetaminophen for Postoperative Pain Control', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '20-1139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral acetaminophen group', 'description': 'the subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval', 'interventionNames': ['Drug: acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV acetaminophen group', 'description': 'the subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively', 'interventionNames': ['Drug: acetaminophen']}], 'interventions': [{'name': 'acetaminophen', 'type': 'DRUG', 'description': 'compare the postoperative pain 1 hour and \\~24h post surgery', 'armGroupLabels': ['IV acetaminophen group', 'Oral acetaminophen group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Fertility Center #3816', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Christine Mullin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health OBGYN Infertility'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the individual participant data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}