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.: PACTR202008462414719 Date of Approval: 13/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title opioid sparing onco-anesthesia for paediatric patients.
Official scientific title Opioid sparing effects of ketamine based total intravenous anesthesia for minor procedures in pediatric oncoanesthesia: comparison between different additives
Brief summary describing the background and objectives of the trial For children with cancer the pain of diagnostic and therapeutic invasive procedures, such as multiple lumbar punctures and bone marrow aspirations , is often worse than that of the disease itself . Long treatment periods and repeated invasive procedures are common in pediatric oncology. Aggressive approaches to the management of procedure pain and anxiety are particularly important.Total intravenous anesthesia can be applied in most areas of pediatric anesthetic practice: for surgical operations, interventional procedures, and sedation outside the OR setting. Our aim of this study is to compare efficacy and safety of different additives to ketamine based TIVA aiming to reduce used of opioid to avoid their side effects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/08/2020
Actual trial start date
Anticipated date of last follow up 15/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 88
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ketamine ketamine 0.5-2 mg/kg bolus dose then 5 µg /kg/min continuous intravenous infusion plus lidocaine bolus dose 2 mg/kg then 2 mg/kg/h continuous intravenous infusion. during the operation patients will receive ketamine 0.5-2 mg/kg bolus dose then 5 µg /kg/min continuous intravenous infusion plus lidocaine bolus dose 2 mg/kg then 2 mg/kg/h continuous intravenous infusion and saline infusion 22 Placebo
Experimental Group propofol patients will receive propofol 1 mg/kg intravenous bolus dose followed by 25 µg/kg/min continuous intravenous infusion during the operation intravenous propofol infusion will be added to ketamine and lidocaine which will be given control group 22
Experimental Group dexmedetomidine patients will receive dexmedetomidine intravenous 0.5 µg/kg intravenous bolus dose within 10 min followed by 0.3 µg/kg/h continuous intravenous infusion during the operation dexmedetomidine will be added to the ketamine and lidocaine which will be given in control group 22
Experimental Group magnesium sulphate patients will receive magnesium sulphate intravenous 40 mg /kg intravenous bolus dose within 5 min followed by 15 mg/kg/h continuous intravenous infusion during the operation magnesium sulphate will be added to ketamine and lidocaine which will be given in the control group 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
eighty eight child aged 2-10 years, ASA physical status I and II, scheduled for brief intervention related to cancer (e.g. intrathecal delivery of chemotherapy, bone marrow aspiration) parents' refusal, procedures > 30 min, complicated interventions, impaired renal or hepatic function, allergy or contraindication to any of studied drugs Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 10 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 02/06/2020 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Elgeish St Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total fentanyl consumption intraoperative and postoperative till discharge from PACU.
Secondary Outcome Hemodynamic parameters (HR and MAP) baseline value, after bolus dose of ketamine or additive drugs then every 5 min till the end of procedures.
Secondary Outcome Frequency of movement intraoperative
Secondary Outcome Recovery time interval from discontinuation of anesthesia until spontaneous eye opening without stimulation
Secondary Outcome Pain score on recovery
Secondary Outcome Length of PACU stay from arrival to PACU until discharge to paediatric department
Secondary Outcome Any adverse effects e.g. PONV, postoperative agitation intraoperative and postoperative up to discharge from PACU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Facualty of Medicine Elgeish st Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt
Mohamed Ahmed Lotfy Elgeish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Elghamry drmonmagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Mona Elghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohamed Lotfy Dr.Mohamed_lotfy@hotmail.com +201222444184 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of total fentanyl consumption, hemodynamic parameters, recovery time, pain score, intraoperative movement, PACU stay, adverse effects Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 1 year. the IPD will be available for every one up on e-mail request. request will be sent to e-mail of principal investigator drmonagh19802000@gmail.com
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