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.: PACTR202106606222881 Date of Approval: 25/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of intravenous ibuprofen on postoperative pain and opioid consumption after pediatric cardiac surgery: A randomized, double-blind, controlled study
Official scientific title The effect of intravenous ibuprofen on postoperative pain and opioid consumption after pediatric cardiac surgery: A randomized, double-blind, controlled study
Brief summary describing the background and objectives of the trial Ibuprofen is a propionic acid derivative with anti-inflammatory, antipyretic, and analgesic effects, like other NSAIDs. The oral form has for long been safely used, and it is one of the most commonly employed NSAIDs. The intravenous (IV) form of ibuprofen has been used in the treatment of mild and moderate pains and to treatment severe pain in combination with opioids since 2009 in the USA. Although there are still insufficient studies concerning IV ibuprofen, it has been shown to be capable of use in the treatment of postoperative pain (Gago Martinez A, et al. 2016, Kroll PB, et al.2011, Moss JR, et al.2014). Aim of the work and hypothesis Up to our knowledge, there is no study has been done to evaluate the effect of intravenous ibuprofen on postoperative analgesia after pediatric cardiac surgery, so the aim of the current study is to test the hypothesis that intravenous ibuprofen may reduce postoperative opioids requirements in pediatric patients submitted for open heart surgery via median sternotomy. The primary outcome measure of this randomized study is the total dose of fentanyl requirements in the first postoperative 24 hours. The secondary outcome measures are postoperative pain score in the first postoperative 24 hours, time to extubation, postoperative renal function test and postoperative non-surgical complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/07/2021
Actual trial start date
Anticipated date of last follow up 01/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
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 Control Group Patients will receive 0.9% normal saline as a placebo. 24 hours Patients will receive 0.9% normal saline as a placebo. 45 Placebo
Experimental Group Ibuprofen Group Patients will receive 10mg/kg intravenous ibuprofen every 6 hours immediately after induction of anesthesia and for 24 hours postoperatively. 24 hours patients will receive 10mg/kg intravenous ibuprofen every 6 hours immediately after induction of anesthesia and for 24 hours postoperatively. 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-patients of either sex. 2- with their age ranging from 2 to 12 years. 3-submitted for on pump elective repair of congenital simple left to right intra cardiac shunt via median sternotomy. 1-refusal of their guardians 2-redo cardiac surgery 3-hypersensitivity to ibuprofen 4-coagulation disorders, renal, hepatic or pulmonary disease 5-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
1-patients of either sex. 2- with their age ranging from 2 to 12 years. 3-submitted for on pump elective repair of congenital simple left to right intra cardiac shunt via median sternotomy. 1-refusal of their guardians 2-redo cardiac surgery 3-hypersensitivity to ibuprofen 4-coagulation disorders, renal, hepatic or pulmonary disease 5-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 25/12/2020 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 Total dose of fentanyl requirements in the first postoperative 24 hours. the first postoperative 24 hours.
Secondary Outcome 1- Post operative pain that will be assessed at 1h, 2h, 6h, 12h, 18, 24 after extubation, and will be managed according to objective pain discomfort score(OPDS) in children. 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 10- Intensive care unit (ICU) length of stay. postoperative 24 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 3516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibrahim Abdelbaser 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 Abdelbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries Nabil Mageed 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 Hani Taman hani_taman@yahoo.com +201008288242 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 Statistical Analysis Plan,Study Protocol 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
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