Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-01 @ 9:52 AM
Study NCT ID:
NCT03678168
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2018-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The participants will be unaware of the type of packaging used port rhinology surgery to control pain and bleeding.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2018-08-19', 'studyFirstSubmitQcDate': '2018-09-18', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of postoperative throat pain using the visual analogue scale (VAS)', 'timeFrame': '2 years', 'description': 'Evaluation of postoperative pain between pharyngeal tampons and controls using the Visual Analogue scale. A value of 0 is the lowest value and indicates the patient is pain free. And a score of 10 is the maximum value which indicates extreme pain on the scale.'}, {'measure': 'postoperative throat bleed', 'timeFrame': '2 years', 'description': 'Evaluation of postoperative bleeding in patients using pharyngeal tampons vs control'}], 'secondaryOutcomes': [{'measure': 'Postoperative recovery', 'timeFrame': '2 years', 'description': 'Assess the postoperative symptom recovery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Postoperative Pain', 'Bleeding', 'Nose Bleed']}, 'referencesModule': {'references': [{'pmid': '17903569', 'type': 'BACKGROUND', 'citation': 'Piltcher O, Lavinsky M, Lavinsky J, de Oliveira Basso PR. Effectiveness of hypopharyngeal packing during nasal and sinus surgery in the prevention of PONV. Otolaryngol Head Neck Surg. 2007 Oct;137(4):552-4. doi: 10.1016/j.otohns.2007.04.004.'}, {'pmid': '21110138', 'type': 'BACKGROUND', 'citation': "Fennessy BG, Mannion S, Kinsella JB, O'Sullivan P. The benefits of hypopharyngeal packing in nasal surgery: a pilot study. Ir J Med Sci. 2011 Mar;180(1):181-3. doi: 10.1007/s11845-010-0601-4. Epub 2010 Nov 26."}, {'pmid': '2067508', 'type': 'BACKGROUND', 'citation': 'Seraj MA, Ankutse MM, Khan FM, Siddiqui N, Ziko AO. Tracheal soiling with blood during intranasal surgery--comparison of two endotracheal tubes. Middle East J Anaesthesiol. 1991 Feb;11(1):79-89.'}, {'pmid': '19192316', 'type': 'BACKGROUND', 'citation': 'Jaiswal V, Bedford GC. Review of the use of throat packs in nasal surgery. J Laryngol Otol. 2009 Jul;123(7):701-4. doi: 10.1017/S0022215109004356. Epub 2009 Feb 4.'}, {'pmid': '11883973', 'type': 'BACKGROUND', 'citation': 'Tay JY, Tan WK, Chen FG, Koh KF, Ho V. Postoperative sore throat after routine oral surgery: influence of the presence of a pharyngeal pack. Br J Oral Maxillofac Surg. 2002 Feb;40(1):60-3. doi: 10.1054/bjom.2001.0753.'}]}, 'descriptionModule': {'briefSummary': 'Post-operative, throat pain, nausea and vomiting is a common occurrence in rhinology surgeries due to the use of throat packs during the procedure. In order to optimize quality of care and patient satisfaction, the aim of this study to evaluate the incidence of post-operative, throat pain, nausea and vomiting in patients that have been packed with either conventional gauze throat packs or pharyngeal tampons.', 'detailedDescription': 'The nose and para nasal sinuses are anatomically known to be highly vascular and a substantial amount of bleeding is expected from rhinology surgeries, ingested blood is known to be a power full emetic, and the risk aspiration of blood is present due to the fact that an endotracheal tube is not 100% effective in protecting the airway. Post-operative nausea and vomiting is a frequent problem that is encountered in surgical patients with a 4th to 6th fold increase in nasal and endoscopic sinus operations.\n\nPosterior throat pack is an often-used in rhinology surgery, it is said to help in protecting the air way against aspiration and also helps in the reduction of post-operative nausea and vomiting, however many studies concluded that posterior throat pack is associated with higher amount of post-operative pain, nausea,, vomiting and in some rare cases even forgotten in the patient leading to mortality. However, despite poor evidence the placement of posterior throat packs is commonly practiced by surgeons and anesthetists because the possible risk of aspiration is worrisome to the latter and the former.\n\nA conventional throat pack consists of gauze, but an alternative practice involves the pharyngeal placement of tampons. In Marais and Prescott posterior pharyngeal placement of tampons is associated with a decrease amount of post-operative throat pain, when compared to conventional gauze throat packs, however they did not compare the incidence of post-operative nausea and vomiting in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients ( above the age of 18 years)\n* Admitted under Dr. Hiba Al-Reefy\n* Underwent a rhinology procedure that required the use of a throat pack\n\nExclusion Criteria:\n\n* Pediatric patients\n* Pt who underwent a procedure without the use of throat packs'}, 'identificationModule': {'nctId': 'NCT03678168', 'briefTitle': 'A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'King Hamad University Hospital, Bahrain'}, 'officialTitle': 'A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries', 'orgStudyIdInfo': {'id': 'KHUH/216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Standard care (Throat pack) which will be used as a control.', 'interventionNames': ['Other: Throat Pack']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Pharyngeal tampons which will be used as a comparator against throat pack.', 'interventionNames': ['Other: Pharyngeal Tampons']}], 'interventions': [{'name': 'Throat Pack', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'Post rhinology surgery throat packs will be used as a control to compare against the intervention (Pharyngeal tampons)', 'armGroupLabels': ['Control']}, {'name': 'Pharyngeal Tampons', 'type': 'OTHER', 'otherNames': ['Intervention'], 'description': 'Post rhinology surgery Pharyngeal Tampons will be used as an intervention to compare against the throat pack (control)', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '244343', 'city': 'Al Muharraq', 'state': 'Muharraq, Bahrain', 'country': 'Bahrain', 'facility': 'King Hamad University Hospital', 'geoPoint': {'lat': 26.25722, 'lon': 50.61194}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Hamad University Hospital, Bahrain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}