Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-03 @ 4:13 PM
Study NCT ID:
NCT01786434
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2013-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine or On-demand Fentanyl in Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2013-01-03', 'studyFirstSubmitQcDate': '2013-02-07', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'The day after the procedure', 'description': 'Patients are asked about satisfaction with information and treatment (yes/no)'}, {'measure': 'Complications', 'timeFrame': 'During the procedure', 'description': 'Sedation-related complications during the procedure'}, {'measure': 'Caecum intubation time', 'timeFrame': 'During the procedure', 'description': 'Time to reach the caecum (minutes)'}, {'measure': 'Caecum intubation rate', 'timeFrame': 'During the procedure', 'description': 'The number of complete procedures divided by the total number of procedures'}, {'measure': 'Willingness to repeat', 'timeFrame': 'Within one hour after the procedure', 'description': 'The patient is asked whether he/she would be willing to have the procedure again in the same way (yes/no).'}, {'measure': 'Recovery time', 'timeFrame': 'Immediately after the procedure Within one hour after the procedure', 'description': 'Time elapsing between end of procedure until leaving the department'}], 'primaryOutcomes': [{'measure': 'Pain during colonoscopy', 'timeFrame': 'Immediately after the procedure and after 24 hours', 'description': 'Pain is recorded on a 4 point Likert scale and a 100 mm VAS scale.'}], 'secondaryOutcomes': [{'measure': 'Additional medication', 'timeFrame': 'During the colonoscopy', 'description': 'The investigators want to assess the need for additional medication during the colonoscopy in the "routine fentanyl-arm" compared to the "fentanyl on-demand arm".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'pain'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '27305424', 'type': 'DERIVED', 'citation': 'Holme O, de Lange T, Stallemo A, Wiig H, Hasund A, Dvergsnes K, Garborg K, Ystrom CM, Loberg M, Hoff G, Bretthauer M, Kalager M. Routine vs. on-demand analgesia in colonoscopy: a randomized clinical trial. Endoscopy. 2016 Sep;48(9):823-8. doi: 10.1055/s-0042-108433. Epub 2016 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore routinely administered in most countries. In Norway, however, routine sedation is rare, and medication is normally given on demand, that is, if necessary during the procedure. The investigators want to evaluate whether the effect of fentanyl, a synthetic opioid with fast onset of action, is better given before the procedure than during the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75\n* Referred for out-patient colonoscopy\n\nExclusion Criteria:\n\n* ASA-score 3 or higher\n* Same day upper endoscopy\n* Pregnancy\n* Pacemaker\n* Patient require medication before colonoscopy\n* Previous resection of colon or rectum\n* Significant psychiatric morbidity\n* Oxygen saturation \\< 95% without supplementary oxygen\n* Contra indications to fentanyl\n* Inability to sign inform consent\n* Inability to understand information about the trial'}, 'identificationModule': {'nctId': 'NCT01786434', 'acronym': 'FEKOL', 'briefTitle': 'Routine or On-demand Fentanyl in Colonoscopy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'officialTitle': 'Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2012/1737'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Routine medication arm', 'description': 'Fentanyl is given routinely to all patients before the procedure', 'interventionNames': ['Drug: Routine medication arm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl on-demand arm', 'description': 'Fentanyl is given during the procedure if the patient experiences pain', 'interventionNames': ['Drug: Fentanyl on-demand arm']}], 'interventions': [{'name': 'Routine medication arm', 'type': 'DRUG', 'otherNames': ['fentanyl'], 'description': '50 micrograms of fentanyl given before the procedure', 'armGroupLabels': ['Routine medication arm']}, {'name': 'Fentanyl on-demand arm', 'type': 'DRUG', 'otherNames': ['Fentanyl'], 'description': 'Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.', 'armGroupLabels': ['Fentanyl on-demand arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Sorlandet Hospital Kristiansand', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}], 'overallOfficials': [{'name': 'Oyvind Holme, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sorlandet Hospital HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}