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.: PACTR201901699494129 Date of Approval: 25/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of fluirbiprofen and lidocaine on sore throat due to the upper gastrointestinal system endoscopy
Official scientific title Effect of fluirbiprofen and lidocaine on sore throat due to the upper gastrointestinal system endoscopy: Randomized controlled study
Brief summary describing the background and objectives of the trial Upper Gastrointestinal System Local analgesic sprays (lidocaine 2%, 10%) are routinely used for sore throat due to endoscopy. however, some patients experience sore throat during and after the procedure. A fully active drug for the procedure has still not been found. In our study, we aimed to evaluate the efficacy of the nonsteroidal antiinflammatory flurbiprofen spray to prevent sore throat from upper gastrointestinal endoscopy.
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,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/12/2018
Actual trial start date
Anticipated date of last follow up 28/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group saline group 5 puff single applied We aim to find the incidence of sore throat associated with processing by applying saline in upper gastrointestinal endoscopy. we will compare the effectiveness of the drugs we will apply in other groups accordingly 50 Placebo
Experimental Group lidocaine group initially we will apply 5 puffs at once. single dose used According to the study protocol we will give lidocaine to the upper gastrointestinal endoscopy. We aimed to find the rate of sore throat associated with the procedure. we will compare our results with the plesabo and flurbiprofen group 50
Experimental Group Flurbiprofen group Initially 5 puffs to be applied at once single use According to the study protocol, we will administer flurbiprofen in upper gastrointestinal endoscopy to this group. We aimed to find out whether there is a sore throat associated with the procedure and the rate. we will compare our results with plesabo and lidocaine group. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. 18-60 years of age elective endoscopy to be applied 2. American society of Anesthesia I-II 3. Mallampati I-II 4. Patients who have not undergone surgery 5. Patients have not received radiotherapy 1. Patients who do not agree to participate in the study 2. Upper airway anomaly or infection 3. Smokers with sore throat 4. Endoscopes failed on first entry 5. Pregnant, those with drug allergy 6. Cases of emergency surgery, 7. Patients who have previously used Flurbiprofen 8. Patients without co-operation 9. Nazogastric catheter insertion 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 28/10/2018 Mogadishu Somali Turkey Recep Tayyip Erdogan Training and Research Hospital Local Ethic Comity
Ethics Committee Address
Street address City Postal code Country
Wadada Recep Tayyip Erdogan Mogadishu 343434 Somalia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Find the incidence of sore throat due to the application of upper gastrointestinal system endoscopy and compare the effectiveness of lidocaine and flurbiprofen with the saline group 5. min to 60 minutes after the process
Secondary Outcome To evaluate possible side effects of lidocaine, flurbiprofen used in the treatment of sore throat due to upper gastrointestinal endoscopy 5. min to 60 minutes after the process
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mogadishu Somali Turkey Recep Tayyip Erdogan Training and Research Hospital Wadada recep tayyip erdogan mogadishu Somalia
FUNDING SOURCES
Name of source Street address City Postal code Country
Mogadishu Somali Turkey Recep Tayyip Erdogan Training and Research Hospital Wadada Recep Tayyip Erdogan Mogadishu Somalia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mogadishu Somali Turkey Recep Tayyip Erdogan Training and Research Hospital Wadada Recep Tayyip Erdogan Mogadishu Somalia Hospital
COLLABORATORS
Name Street address City Postal code Country
Halima Abdulkadir Ahmed Wadada Recep Tayyip Erdogan mogadishu 3434 Somalia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator seyfi Kartal drseyfikartal@gmail.com +903124424240 Wadada Recep Tayyip Erdogan
City Postal code Country Position/Affiliation
Mogadishu Somalia Ass. Prof. Dr.
Role Name Email Phone Street address
Public Enquiries Saamira Hassan samaara010@gmail.com +903124424240 Wadada Recep Tayyip Erdogan
City Postal code Country Position/Affiliation
Mogadishu Somalia Miss.
Role Name Email Phone Street address
Scientific Enquiries Halima Abdulkadir shadiya29@hotmail.com +252615438071 Wadada Recep tayyip Erdogan
City Postal code Country Position/Affiliation
Mogaishu Somalia research assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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