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.: PACTR201812490692464 Date of Approval: 11/12/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of flurbiprofen and benzydamine hydrochloride in sore throat due to the Laryngeal Mask Airway
Official scientific title The effect of flurbiprofen and benzydamine hydrochloride in sore throat due to the Laryngeal Mask Airway: a randomized controlled trial
Brief summary describing the background and objectives of the trial Various lozenges (Dexpanthenol lozenge), local analgesic sprays (2% lidocaine 2%, 10%) and nonsteroidal antiinflammatory drugs (benzydamine hydrochloride spray) have been used for sore throat due to laryngeal mask airway (LMA), and no effective drug has yet been found. In our study, we aimed to evaluate the efficacy of the nonsteroidal antiinflammatory flurbiprofen spray in preventing postoperative sore throat pain due to LMA application.
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 single dose apply once To evaluate the possible sore throat pain associated with laryngeal mask airway, we aim to find the incidence of sore throat by applying saline. we will compare the effectiveness of the drugs we will apply in other groups with this group 50 Active-Treatment of Control Group
Experimental Group flurbiprofen group single dose apply once To evaluate possible sore throat due to laryngeal mask airway, we aim to find the number of possible sore throat patients by applying flurbiprofen. our results will be compared with the control group and the other group of drugs 50
Experimental Group Benzidamine group single dose apply once o evaluate possible sore throat due to laryngeal mask airway, we aim to find the number of patients with sore throat by administration of benzidamine. our results will be compared with the control group and the other group of drugs. 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 I-II 3. Mallampati I-II 4. They will be surgery in the supine position. 5. Lower limbs will be surgery 6. They will be intestinal surgery 7. They will be perianal surgery 8. They will have genital area surgery 9. 30 min - 1 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. Those who failed to enter the LMA installation 5. Pregnant, sick patients, those with drug allergy 6. Emergency surgery cases, Nasogastric catheter insertion 7. Patients who have used Flurbiprofen before 8. Those with a history of bronchospasm 9. Patients who cannot cooperate 10. Those with ASA III-IV, Mallampati III-IV 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 Somalia Turkey Recep Tayyip Erdogan Training and Research Hospital the local ethics committee
Ethics Committee Address
Street address City Postal code Country
wadda rajab tayyib erdogan mogadishu 343434 Somalia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to evaluate the efficacy of flurbiprofen and benzidamine hydrochloride in preventing sore throat that may occur due to laryngeal mask airway application postop first 30 min to postop 6th hour
Secondary Outcome to evaluate other side effects (such as dryness of the throat, swallowing, nausea and vomiting) due to laryngeal mask airway application. postop first 30 min to postop 6th hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mogadishu Somalia 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 Somalia Turkey Recep Tayyip Erdogan Training and Research Hospital wadada rajab tayyip erdogan mogadishu 343434 Somalia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mogadishu Somalia Turkey Recep Tayyip Erdogan Training and Research Hospital wadada recep tayyip erdogan mogadishu Somalia Hospital
COLLABORATORS
Name Street address City Postal code Country
Duran Hashi Awale Wadada Recep Tayyip Erdogan mogadishu 3434 Somalia
Recep Erin Wadada Recep tayyip Erdogan mogadishu 343434 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 recep erin erinrecp@gmail.com +903124424240 wadada recep tayyip erdogan
City Postal code Country Position/Affiliation
mogadsihu Somalia Ass. Prof. Dr.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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