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.: PACTR202004795873163 Date of Approval: 16/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Does gabapentin reduce postoperative opioid analgesic requirements in pediatric open heart surgery?
Official scientific title Does gabapentin reduce postoperative opioid analgesic requirements in pediatric open heart surgery?
Brief summary describing the background and objectives of the trial Introduction: Opioids are the gold standard for postoperative pain management in cardiac surgeries. On the other hand excessive use of opioid leads to undesirable side effects such as excessive sedation, drowsiness, dizziness, nausea, vomiting and respiratory depression. Currently, no previous studies designed to study the analgesic effects of gabapentin in pediatric cardiac surgery analgesia, so we aim study the effects of adding this drug on post-operative pain control and opioid consumption in pediatric population undergoing on pump surgical repair of cardiac defects. This prospective double –blind randomized study will be conducted on (50) patients of either sex who will be planned to undergo elective correction of congenital heart diseases using cardiopulmonary bypass Patients and Methods: Eligible 50 patients will be randomly allocated into 2 equal groups: Gabapentin (G) group (n=25): Oral Gabapentin at 40mg/kg/day diluted in 15 sterile water will be administrated divided in 3 equal doses. Placebo group (P) group (n=25): will receive empty similar solution. The main collected data will be perioperative opioids requirements, intraoperative hemodynamic stress response, time to extubation and postoperative pain score
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/03/2020
Actual trial start date 15/03/2020
Anticipated date of last follow up 01/04/2021
Actual Last follow-up date 01/06/2021
Anticipated target sample size (number of participants) 50
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 5 ml of empty normal saline as placebo every 8 hours starting orally 2 hours pre-operative followed by ryle orogastric tube for total of 48 hours 25 Placebo
Experimental Group Gabapentin group solution of Gabapentin at 40mg/kg/day divided in 3 equal doses every 24 hours 48 hours Gabapentin at 40mg/kg/day will be diluted in 15 ml normal saline and will be given every 8 hours starting orally 2 hours pre-operative then in the ryle tube for total of 48 hours 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
the study will be conducted on (50) patients of either sex with their age ranging from 3to 12 years who will be planned to undergo elective correction of congenital heart diseases using cardiopulmonary bypass. Patients will be excluded from the current study in case of refusal of their guardians, redo cardiac surgery, hypersensitivity to gabapentin, 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 3 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 02/03/2020 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 fentanyl 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. 1h, 2h, 6h, 12h, 18 h, 24 h, 36 h,48 h after extubation
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-Time to extubation (hours). 6-Time of first rescue analgesia 7- Intensive care unit (ICU) length of stay. 8-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
Mohamed Ahmed Maher Ibrahim Elmorsy 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
Mohamed Ahmed Maher Ibrahim Elmorsy 2 El-Gomhouria Street Mansoura 35516 Egypt
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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elmorsy m.am.elmorsy@gmail.com +201112582480 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at faculty of medicine Mansoura University
Role Name Email Phone Street address
Public Enquiries Ibrahim Abd Elbaser 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 faculty of medicine Mansoura University
Role Name Email Phone Street address
Scientific 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
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Non identified patients data will be available in excel sheets with the principle investigator for 6 months after publication of the paper. Informed Consent Form,Study Protocol Documents will be available within 6 months after publication of the paper. Open access to IPD to reviewers. Data will be send directly by email upon request. m.am.elmorsy@gmail.com
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