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.: PACTR202402589581256 Date of Approval: 22/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The interest of preoperative lidocaine 2% nebulization among children with a cold undergoing ambulatory surgery : a randomized controlled trial
Official scientific title The impact of preoperative lidocaine nebulization among children with an Upper respiratory tract infection : a randomized controlled trial
Brief summary describing the background and objectives of the trial Lidocaine is a local anesthetic that has anti-inflammatory effects, and it was previously used in nebulization for children undergoing bronchoscopy. We think that its local anesthesia effects may reduce the risk of bronchospasm. So, we suggest studying its effect on children with mild signs of a cold. The aim of this study is to investigate the impact of lidocaine 2% nebulization among children with a cold on the incidence of perioperative respiratory adverse events (bronchospasm, laryngospasm, and oxygen desaturation)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2024
Actual trial start date
Anticipated date of last follow up 30/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Active, not 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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lidocaine nebulization inhalation of 2mg/kg of lidocaine (nebulization of 1ml of lidocaine 2% per 10 kg of weight) one hour before surgery 15 min nebulization of lidocaine 2% for children undergoing ambulatory surgery while they suffers from mild symptoms of a cold 50
Control Group saline nebulization 0.1 ml/kg normal saline nebulization 15 min normal saline nebulization for children undergoing ambulatory surgery while they have mild signs of a cold 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children aged 1 - 5 years with mild signs of upper respiratory tract infection undergoning elective ambulatory ilio inguinal surgery children with fever > 38 °C or ronchi age < 1yo or > 5yo patients whose parents did not consent to participate Preschool Child: 2 Year-5 Year 1 Year(s) 5 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 14/06/2023 Comit de protection des personnes sud
Ethics Committee Address
Street address City Postal code Country
el ain road km 0.5 at faculty of medecine of sfax sfax 3000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of PRAEs peroperatively and postoperatively during the 2 first postoperative hours
Secondary Outcome safety of lidocaine inhalation in children with mils signs of a cold from the drug administration to the hospital discharge of the patient
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hedi Chaker University Hospital El Ain Road Km 0.5 sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Hedi Chaker university hospital el ain road km 0.5 sfax 3000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hedi Chaker university hospital el ain road km 0.5 sfax 3000 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator anouar jarraya dranouarjarraya1983@gmail.com +21692553300 el ain road km 0.5
City Postal code Country Position/Affiliation
sfax 3000 Tunisia head of the pediatric anesthesia department
Role Name Email Phone Street address
Scientific Enquiries manel kammoun manelkammoun6@gmail.com 0021699230229 el ain road km 0.5
City Postal code Country Position/Affiliation
sfax 3000 Tunisia anesthesiologist in the pediatric anesthesia department
Role Name Email Phone Street address
Public Enquiries kamel kolsi kammoul.kolsi@gmail.com 0021658157976 el ain road km 0.5
City Postal code Country Position/Affiliation
sfax 3000 Tunisia anesthesiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We plan to make our individual participant data available to journal editor, reviewers, and researchers interested, under reasonabe request Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol at the end of the study Editor reviewers
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