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.: PACTR202003519479017 Date of Registration: 04/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of low dose ketamine infusion on perioperative opioid requirements in pediatric on pump cardiac surgery
Official scientific title The effect of low dose ketamine infusion on perioperative opioid requirements in pediatric on pump cardiac surgery
Brief summary describing the background and objectives of the trial Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site. Pain after cardiac surgery is most severe during the first day and then decreases in intensity over the next few days. Systemic opioids have been the mainstay for managing pain during the perioperative period in children undergoing median sternotomy for cardiac surgery. Ketamine often is used for procedural sedation because of its combined sedative and analgesic properties as well as its lack of respiratory depression and favorable hemodynamic profile at doses used for this purpose. It also has been used as an adjunctive analgesic agent for opioid-tolerant patients, for sedation of patients in whom intravenous access is not available, as an additive to local anesthetics, and most recently as a novel therapeutic option for treatment-resistant depression. Several studies have examined its opioid-sparing effects in the perioperative context, which has led some to advocate for its inclusion as part of an enhanced recovery after cardiac surgery protocol. The objective of this trial is to evaluate the effects of the intraoperative infusion of ketamine, compared with the placebo, at a dosing regimen shown to be effective in other surgical populations, in pediatric patients undergoing on pump cardiac surgery. The hypothesis is that a ketamine bolus and infusion during pediatric cardiac surgery may decrease postoperative opioid consumption.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 29/02/2020
Actual trial start date 29/02/2020
Anticipated date of last follow up 01/02/2021
Actual Last follow-up date 01/04/2021
Anticipated target sample size (number of participants) 76
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo control group Patients will receive normal saline 48 hours patients will receive placebo for 48 hours 38 Placebo
Experimental Group Ketamine Group Ketamine will be diluted in 50 ml of normal saline to a concentration of 10 mg/ml and the placebo control will consist of 50 ml of normal saline. The study solutions will be labeled as ‘study drug 10 mg/ml, and will be administered by the patient’s primary anesthesiologist who will be unaware of its content. Ketamine will be administered intravenously (IV) as follows: a loading dose of 0.5 mg/kg prior to surgical incision, an intraoperative infusion at 0.25 mg/kg/h and a postoperative infusion at 0.1 mg/kg/h. 48 hours Ketamine will be diluted in 50 ml of normal saline to a concentration of 10 mg/ml and the placebo control will consist of 50 ml of normal saline. The study solutions will be labeled as ‘study drug 10 mg/ml, and will be administered by the patient’s primary anesthesiologist who will be unaware of its content. Ketamine will be administered intravenously (IV) as follows: a loading dose of 0.5 mg/kg prior to surgical incision, an intraoperative infusion at 0.25 mg/kg/h and a postoperative infusion at 0.1 mg/kg/h. 38
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This study will be conducted on 76 patients of either sex with their age ranging from 2 to 12 years submitted for on pump elective repair of congenital simple left to right intra cardiac shunt via median sternotomy. Patients will be excluded from the current study in case of refusal of their guardians, redo cardiac surgery, hypersensitivity to ketamine, coagulation disorders, renal, hepatic or pulmonary disease, heart failure and moderate to severe pulmonary hypertension. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 12 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 17/02/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El-Gomhouria Street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Total dose of postoperative morphine consumption during the postoperative 48 hours. 2- Post operative pain that will be assessed at 1h, 2h, 6h, 12h, 18 h, 24 h, 36 h,48 h after extubation, and will be managed according to objective pain discomfort score(OPDS) in children. 1- Total dose of postoperative morphine consumption during the postoperative 48 hours. 2- Post operative pain that will be assessed at 1h, 2h, 6h, 12h, 18 h, 24 h, 36 h,48 h after extubation, and wil
Secondary Outcome 1-Heart rate [HR] and invasive mean arterial blood pressure [MAP] will be recorded; before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum. 2- Total dose of intra operative fentanyl requirements(ug/kg). 3- Aortic cross clamping time (minutes). 4- Cardiopulmonary bypass time (minutes). 5-The number of patients who will be extubated in operating room (within 15 minutes of the end of surgery) were recorded. 6- Time to extubation (hours). 7- Post extubation PaO2, PaCO2 will be assessed each 3 hour for 24 hours. 8-Time of first rescue analgesia 9- Total dose of morphine consumption in the first 48 postoperative hours. 10- Intensive care unit (ICU) length of stay. 11- Postoperative complications (the need for re-intubation, nausea and vomiting, pruritus, respiratory depression and neurological deficits) will be reported. 48 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
Nabil Abd El raouf Abd El mageed 2 El-Gomhouria Street Mansoura 35516 Egypt
Mohamed Maher El Morsy 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abd Elbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
Role Name Email Phone Street address
Public Enquiries Nabil Abd Elraouf nabil_abdelraouf@yahoo.com +201001538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mohamed El Morsy dr.sevo.anesthesia@gmail.com +201112582480 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will individual participate data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://irb.mans.edu.eg 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