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.: PACTR202101661828558 Date of Approval: 14/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intravenous ibuprofen versus ketorolac for postoperative analgesia in children undergoing lower abdominal surgery: A randomized, controlled study
Official scientific title Intravenous ibuprofen versus ketorolac for postoperative analgesia in children undergoing lower abdominal surgery: A randomized, controlled, study
Brief summary describing the background and objectives of the trial Background: 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. Aim: The aim of this study is to compare the postoperative analgesic effect of intravenous ibuprofen and ketorolac in children undergoing lower abdominal surgeries. Methods: Sixty four children of American Society of Anesthesiologists physical status I–II aged from 1 to 8 years scheduled for elective lower abdominal surgery will be enrolled in this study. Patients will be randomly allocated to one of two equal groups (32 patients for each). Control (Ketorolac) group (n=32): the patients will receive intravenous ketorolac 0.5 mg/kg every 6 hours will be given immediately after induction of anesthesia and will be continued up to 24 hours after surgery. Intravenous ibuprofen group (n=32): the patients will receive intravenous ibuprofen 10mg/kg/6 hours that will be given immediately after induction of anesthesia and will be continued up to 24 hours after surgery. Our primary outcome measure will be the postoperative analgesic consumption while the secondary goals will be postoperative pain score, time to first analgesic requirement, number of patients requiring rescue analgesic and incidence drug related 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 03/01/2021
Actual trial start date 10/01/2021
Anticipated date of last follow up 10/06/2021
Actual Last follow-up date 18/06/2021
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status Completed
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Ketorolac group the patients will receive intravenous ketorolac 0.5 mg/kg every 6 hours immediately after induction of anesthesia and will be continued up to 24 hours after surgery. the patients will receive intravenous ketorolac 0.5 mg/kg every 6 hours will be given immediately after induction of anesthesia and will be continued up to 24 hours after surgery. 32 Active-Treatment of Control Group
Experimental Group Intravenous ibuprofen group the patients will receive intravenous ketorolac 0.9 mg/kg every 6 hours immediately after induction of anesthesia and will be continued up to 24 hours after surgery. the patients will receive intravenous ibuprofen 10mg/kg/6 hours that will be given immediately after induction of anesthesia and will be continued up to 24 hours after surgery. 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age from 1 to 8 years. 2- American Society of Anesthesiologists physical status I–II. 3- Elective lower abdominal surgery. 1- History of clinically significant cardiac, hepatic, renal, or neurological dysfunction. 2- Coagulopathy. 3- Allergy to study drugs. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 8 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 24/12/2020 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 The primary outcome measure is the total morphine consumption in the first postoperative 24 h. First postoperative 24 h.
Secondary Outcome 1. Postoperative pain score. 2. Time to first rescue analgesia and its frequency. 3. Parents satisfaction. 4. Postoperative complications (fever, vomiting) first postoperative 24 h.
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
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 at Faculty of Medicine Mansoura University
Role Name Email Phone Street address
Public Enquiries Nabil Abdelraouf nabil_abdelraouf@yahoo.com +201001538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of Anesthesia 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 Assistant Professor of Anesthesia at Faculty of Medicine Mansoura
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 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