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.: PACTR201805003375250 Date of Approval: 08/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Preventing postoperative sore throat in pediatrics.
Official scientific title Postoperative Sore Throat in Pediatrics: A Comparison between 3 Different Preoperative Nebulized Medications.
Brief summary describing the background and objectives of the trial The delivery of aerosolized medication is an important component of treatment for many respiratory disorders in children. Glucocorticoids, bronchodilators, antibiotics, mucus hydration agents, and mucolytic agents can be administered via aerosol. We used this mode of medication delivery as a preemptive strategy to alleviate postoperative sore throat (POST) in children receiving general anesthesia. Although the POST resolve spontaneously without any treatment, prophylactic management for decreasing its frequency, and severity is desirable so that children can have a more satisfying experience. Ketamine, magnesium sulfate and dexamethasone are shown to be promising agents to reduce POST. The primary aim of the study was to compare the effects of ketamine, magnesium sulfate and dexamethasone nebulization in a preemptive manner, on the incidence and severity of POST.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,postoperative sore throat,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 09/05/2018
Actual trial start date 09/05/2018
Anticipated date of last follow up 01/09/2018
Actual Last follow-up date 01/09/2018
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group K (Ketamine group) received ketamine 1 mg/kg nebulization Preoperative nebulization and the volume of drug was completed to 5 ml by normal saline 36
Experimental Group group M (Magnesium group) received magnesium sulphate 25 mg/kg by nebulization Preoperative nebulization was done and the volume of drug was completed to 5 ml by normal saline 36
Experimental Group group D (Dexamethasone group) received dexamethasone 0.16 mg /kg by nebulization Preoperative nebulization was done and the volume of drug was completed to 5 ml by normal saline 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
6 to 16 yrs. ASA physical status I and II either sex undergoing surgeries supine position under general anesthesia lasting for more than one hour. Patients with Mallampati class > 2 pre-operative sore throat, upper respiratory tract infection, allergy to study drug recent history of NSAID medications asthmatics those who require more than two attempts at intubation surgeries requiring nasogastric tube and throat pack insertion duration of surgery >3 hrs. surgeries in lateral and prone position 6 Year(s) 16 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 28/02/2018 Ain Shams university,faculty of medicine, research ethics committee
Ethics Committee Address
Street address City Postal code Country
Abassia, Ramsis street Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of the study was the incidence and severity of POST at 4 h. post-operatively in pediatric patients undergoing surgery of duration of up to 1 h. under general anesthesia (GA). at 4 th hour postoperatively
Secondary Outcome The secondary outcomes included evaluation of side-effects including nausea, vomiting, Incidence of postoperative hoarseness of voice and Postoperative sedation score. up to 4 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams educational hospital Abassia, Ramsis street Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain shams university , faculty of medicine Abassia, Ramsis street Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams university , faculty of medicine Abassia, Ramsis street Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mostafa Mansour Houssein 5 Abdelazem salama street, Nasr city Cairo Egypt
Raham Hasan Mostafa Abassia, Ramsis street Cairo Egypt
Ashraf Nabil Saleh Abassia, Ramsis street Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Mansour Houssein mostafa_mansour361@hotmail.com 00201093322145 5 Abdelazem salama street, Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of anesthesia and intensive care, faculty of medicine, Ain shams university
Role Name Email Phone Street address
Public Enquiries Mostafa Mansour Houssein mostafa_mansour361@hotmail.com 00201093322145 5 Abdelazem salama street, Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of anesthesia and intensive care, faculty of medicine, Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Mostafa Mansour Houssein mostafa_mansour361@hotmail.com 00201093322145 5 Abdelazem salama street, Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of anesthesia and intensive care, faculty of medicine, Ain shams university
REPORTING
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