Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201909823246718 Date of Approval: 27/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Soaking oro-pharyngeal pack with triamcinolone, effects on postoperative throat discomfort
Official scientific title Study of effects of soaking oro-pharyngeal pack with triamcinolone acetonide in ora-base form on postoperative throat discomfort in patients undergoing functional endoscopic sinus surgeries
Brief summary describing the background and objectives of the trial Oro-pharyngeal pack is known to increase postoperative throat discomfort. This study tests the possibility of decreasing this discomfort with adding triamcinolone acetonide in ora-base to oro-pharyngeal pack
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Ear, Nose and Throat,Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 11/04/2019
Actual trial start date 11/04/2019
Anticipated date of last follow up 16/09/2019
Actual Last follow-up date 16/09/2019
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 54
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Study Group Triamcinolone Acetonide in ora-base, 15 mg for the duration of the functional endoscopic sinus surgery Th oro-pharyngeal pack used is soaked with triamcinolone acetonide 15 mg before inserted in the oropharynx. 27
Control Group Control Group same volume of lubricating gel for the duration of functional endoscopic sinus surgery the oro-pharyngeal pack used is soaked with a lubricating gel in equal volume to the study group 27 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients undergoing functional endoscopic sinus surgery age between 18 and 60 years old ASA I and II Modified Mallampati Grades I and II no previous preexisting laryngeotracheal disease presumed to undergo easy intubation duration of surgery 2-3 hours pharyngeal infection pharyngeal ulceration smokers if patients endotracheal intubation requires more than one attempt for successful tube placement patients on corticosteroids patients on non-steroidal anti-inflammatory drugs Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/04/2019 Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Ain Shams University, Abbasia, Cairo, Egypt. Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Soar throat half an hour after extubation, 2-6 hours after extubation, 24 hours after extubation
Secondary Outcome Dysphagia 24 hours after extubation
Secondary Outcome Hoarseness of voice 24 hours after extubation
Secondary Outcome Postoperative nausea and vomiting 24 hours after extubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University Ramsis St. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif Sayyed Ali Sultan and Dalia Fahmy Emam and Mohamed Ibrahim Hasan and Nouran Mohsen Ahmed Fahmy Abbasia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ain shams university Ramsis St. Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dalia Fahmy Emam Cairo Cairo Egypt
Mohamed Ibrahim Hasan Cairo Cairo Egypt
Nouran Mohsen Ahmed Fahmy Cairo Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary Resultas Statistical Analysis Plan 6 months after publication internet search by keywords
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information