Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-04 @ 8:41 AM
Study NCT ID:
NCT00232492
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2005-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine on Acute Pain in Females and Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014095', 'term': 'Tooth, Impacted'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-03', 'studyFirstSubmitDate': '2005-09-30', 'studyFirstSubmitQcDate': '2005-10-02', 'lastUpdatePostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum pain NRS', 'timeFrame': '60 min'}], 'secondaryOutcomes': [{'measure': 'Several subjective variables assessing psychotomimetic effects', 'timeFrame': '0, 15, 60'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wisdom', 'Tooth', 'Teeth', 'Third', 'Molar'], 'conditions': ['Mouth and Tooth Diseases', 'Tooth, Impacted']}, 'referencesModule': {'references': [{'pmid': '8351166', 'type': 'BACKGROUND', 'citation': 'Oye I, Mathisen LC. The effect of CPP in neurogenic pain: inhibition of spinal or cortical NMDA receptors? Pain. 1993 Jun;53(3):358. doi: 10.1016/0304-3959(93)90234-G. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Øye I, Hustveit O, Maurset A, Ratti Moberg E, Paulsen O, Skoglund LA. The chiral forms of ketamine as probes for NMDA receptor functions in humans. In: NMDA receptor related agents: Biochemistry, pharmacology and behaviour. Kameyama T, Domino E (eds). NPP Books, Ann Arbor, 1991.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether equal subanesthetic doses of racemic ketamine is equally effective on females and males after surgical removal of third molars', 'detailedDescription': 'Ketamine is assumed to be a NMDA receptor antagonist which provides analgesia from acute postoperative pain(and other types of pain) subanesthetic doses. Gender differences in ketamine analgesia are not known. This placebo-controlled,randomised, parallel group study investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female and male patients following surgical removal of third molars.\n\nComparisons: Placebo and ketamine in females and males.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for removal of third molar\n* Between 20 and 30 years of age\n* ASA Class 1\n\nExclusion Criteria:\n\n* Psychiatric family (father/mother) or own anamnestic history\n* Hypersensitivity towards NSAIDS or other rescue analgesics\n* Verified or suspected pregnancy\n* Lactating females\n* Surgery lasting over 60 min'}, 'identificationModule': {'nctId': 'NCT00232492', 'briefTitle': 'Ketamine on Acute Pain in Females and Males', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars', 'orgStudyIdInfo': {'id': 'DOK-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo males', 'description': 'Saline physiological placebo males', 'interventionNames': ['Drug: Placebo males']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine 0,1 mg/kg males', 'description': '0,1 mg/kg ketamine males', 'interventionNames': ['Drug: Ketamine 0,1 mg/kg males']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine 0,3 mg/kg males', 'description': '0,3 mg/kg ketamine males', 'interventionNames': ['Drug: Ketamine 0,3 mg/kg males']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine 0,5 mg/kg males', 'description': '0,5 mg/kg ketamine males', 'interventionNames': ['Drug: Ketamine 0,5 mg/kg males']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo females', 'description': 'Saline physiological as placebo females', 'interventionNames': ['Drug: Placebo females']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine 0.1 mg/kg females', 'description': '0,1 mg/kg ketamine females', 'interventionNames': ['Drug: Ketamine 0,1 mg/kg females']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine 0,3 mg/kg females', 'description': '0,3 mg/kg ketamine females', 'interventionNames': ['Drug: Ketamine 0,3 mg/kg females']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine 0,5 mg/kg females', 'description': '0,5 mg/kg ketamine females', 'interventionNames': ['Drug: Ketamine 0,5 mg/kg females']}], 'interventions': [{'name': 'Placebo males', 'type': 'DRUG', 'otherNames': ['saline physiological 5 ml'], 'description': 'Intravenous saline bolus (Placebo-control) males', 'armGroupLabels': ['Placebo males']}, {'name': 'Ketamine 0,1 mg/kg males', 'type': 'DRUG', 'otherNames': ['Ketalar ATC-nr.: N01A X03'], 'description': '0,1 mg/kg ketamine iv bolus males', 'armGroupLabels': ['Ketamine 0,1 mg/kg males']}, {'name': 'Ketamine 0,3 mg/kg males', 'type': 'DRUG', 'otherNames': ['Ketalar ATC-nr.: N01A X03'], 'description': '0,3 mg/kg ketamine iv bolus males', 'armGroupLabels': ['Ketamine 0,3 mg/kg males']}, {'name': 'Ketamine 0,5 mg/kg males', 'type': 'DRUG', 'otherNames': ['Ketalar ATC-nr.: N01A X03'], 'description': '0,5 mg/kg ketamine iv bolus males', 'armGroupLabels': ['Ketamine 0,5 mg/kg males']}, {'name': 'Placebo females', 'type': 'DRUG', 'otherNames': ['Saline physiological 5 ml'], 'description': 'Intravenous saline bolus (Placebo-control) females', 'armGroupLabels': ['Placebo females']}, {'name': 'Ketamine 0,1 mg/kg females', 'type': 'DRUG', 'otherNames': ['Ketalar ATC-nr.: N01A X03'], 'description': '0,1 mg/kg iv bolus ketamine females', 'armGroupLabels': ['Ketamine 0.1 mg/kg females']}, {'name': 'Ketamine 0,3 mg/kg females', 'type': 'DRUG', 'otherNames': ['Ketalar ATC-nr.: N01A X03'], 'description': '0,3 mg/kg iv bolus ketamine females', 'armGroupLabels': ['Ketamine 0,3 mg/kg females']}, {'name': 'Ketamine 0,5 mg/kg females', 'type': 'DRUG', 'otherNames': ['Ketalar ATC-nr.: N01A X03'], 'description': '0,5 mg/kg iv bolus ketamine females', 'armGroupLabels': ['Ketamine 0,5 mg/kg females']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NO-0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Lasse A Skoglund, DDS, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway'}, {'name': 'Olav Hustveit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Professor Lasse A. Skoglund', 'oldOrganization': 'Section of Dental Pharmacology and Pharmacotherapy, University of Oslo, Norway'}}}}