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.: PACTR201901886446133 Date of Registration: 24/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of fluirbiprofen and lidocaine on sore throat due to endotracheal intubation
Official scientific title Effect of fluirbiprofen and lidocaine on sore throat due to endotracheal intubation: Randomized controlled study
Brief summary describing the background and objectives of the trial To prevent sore throat due to ETT, various lozenges (Dexpanthenol lozenge), local analgesic sprays (lidocaine 2%, 10%) and nonsteroidal antiinflammatory drugs (benzydamine hydrochloride spray) were used. a fully active drug has not yet been found. In our study, we aimed to evaluate the effectiveness of nonsteroidal antiinflammatory Flurbiprofen and lidocaine spray in preventing postoperative sore throat.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 16/12/2018
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 one one time applied saline group was accepted as control group. applied at one time. The rates of sore throat were evaluated. other groups were evaluated according to this group 50 Placebo
Experimental Group Flurbiprofen group one one time applied flurbiprofen group applied flurbiprofen spray. this group compared with the control group. The rates of sore throat were evaluated. compared with other groups 50
Experimental Group lidocaine group single dose applied one time applied lidocaine group was administered lidocaine spray. this group was compared with the control group and flurbiprofen. The rates of sore throat were evaluated. compared with other groups 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. The age of 18-60 years will be applied elective surgery 2. American Society of Anesthesia (ASA) I-II 3. Mallampati I-II 4. They will be operate in the supine position 5. They will be operate lower extremity surgery 6. They will be operate inital surgery 7. They will be operate perianal surgery 8. They will have genital area surgery 9. 30 min - 2 hour surgical ones 1. Patients who do not agree to participate in the study 2. Upper airway anomaly or infection 3. Smokers with sore throat 4. They will have throat surgery 5. Endo tracheal tube insertion failures at first, stile used and cricoid compression 6. Pregnant, sick patients, those with drug allergy 7. Emergency surgery cases, Nasogastrik tube inserted 8. Patients who have used Flurbiprofen before 9. Patients who cannot cooperate 10. Those with American Society of Anesthesia III-IV, Mallampati III-IV 11. Those with a history of bronchospasm Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),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 Somalia Turkey Recep Tayyip Erdogan teaching and research hospital of the local ethics committee
Ethics Committee Address
Street address City Postal code Country
wadada rajab tayyip erdagan mogadishu 343434 Somalia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome sore throat, which may be related to endotracheal intubation, will be compared with the control group. postop first hour to first 24 hours
Secondary Outcome as well as possible sore throat pain due to endotracheal tube, possible drug-related side effects, throat dryness, nausea, vomiting its investigated postop first hour to postop first 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mogadishu Somali Turkey Recep Tayyip Erdogan Training and Research Hospital Wadada Rajab 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 rajab 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 rajab tayyip erdogan mogadishu Somalia Hospital
COLLABORATORS
Name Street address City Postal code Country
Recep ERN Wadada Rcep Tayyip Erdogan Street mogadishu 3434 Somalia
Abdullahi Said Hashi Wadada Recep Tayyip Erdogan street mogadishu 3434 Somalia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seyfi Kartal drseyfikartal@gmail.com +905052700508 wadada rajab tayyib erdogan
City Postal code Country Position/Affiliation
mogadishu Somalia Ass. Prof. Dr.
Role Name Email Phone Street address
Public Enquiries samaara hassan samaara010@gmail.com +903124424240 wadada rajab tayyib erdogan
City Postal code Country Position/Affiliation
mogadishu Somalia miss.
Role Name Email Phone Street address
Scientific Enquiries recep erin erinrecep@gmail.com +903124424240 wadada rajab tayyip erdogan
City Postal code Country Position/Affiliation
mogadishu Somalia Ass. Prof. Dr.
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