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.: PACTR201801002961339 Date of Approval: 10/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of preemptive analgesic effect of retrobulbar Block and intravenous Fentanyl in pediatric strabismus surgery
Official scientific title Comparison of preemptive analgesic effect of retrobulbar Block and intravenous Fentanyl in pediatric strabismus surgery
Brief summary describing the background and objectives of the trial The aim of this study is to compare the analgesic effect of the retrobulbar block with IV Fentanyl in children undergoing strabismus surgery. 50 children eligible for elective strabismus surgery in ¿Children Specialized Hospital, Cairo University ¿ will be randomly divided into two groups, group R (Retrobulbar Block group) and group F (IV Fentanyl group). The primary outcome measure is the pain score using the FLACC score. Secondary outcome measures is the incidence of postoperative nausea and/or vomiting and the rate of complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Paediatrics,Strabismus,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/01/2018
Actual trial start date 05/11/2017
Anticipated date of last follow up 21/03/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple Randomisation Sealed envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Retrobulbar Block 2-4 ml ( 2%Lidocaine + 0.5% Bupivicaine) Regional Retrobulbar Block 25 Active-Treatment of Control Group
Control Group Fentanyl intravenous 1 microgram/kg Intravenous Fentanyl 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Children undergoing primary bilateral horizontal rectus muscle recession either bilateral medial rectus or bilateral lateral rectus muscle recession through a fornix incision. ¿ Age Group: 2-12 years ¿ Recurrent or incomitant strabismus ¿ Muscle resection ¿ Limbal incisions ¿ Children outside our age limit ¿ Children with tumors, infections of the orbit or eye injury ¿ Children with increased IOP or compromised sclera ¿ Children with coagulopathy ¿ Children with a history of allergy to local anesthetics or opioids ¿ Intraoperative complicated cases such as slipped or lost muscles and perforations 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 09/02/2016 Pediatric Ophthalmology Department, Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Vital signs (Heart rate, blood pressure,on saturation) Intraoperative. After induction (baseline), at retrobulbar injection, at the surgical incision, and then at 5-min intervals until the end of surgery.
Secondary Outcome Complications. FLACC score Complications all through. FLACC score postoperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Children specialized Hospital, Cairo University. Kasr Alainy Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Kasr Alainy Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Children specialized hospital, Cairo University, Kasr Alainy Kasr Alainy Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Ahmed Selim Building 88, 4th touristic area, 6th October Cairo Egypt
Fatma Nada 6 Abbas elakad, Madinet Nasr Cairo Egypt
Dina Hossam 8 ElDoki st. , Elmohandseen Cairo Egypt
Ahmed Kamal 104 Degla st., ElMaadi Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Selim mohamedahmedselim@kasralainy.edu.eg 201001430841
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia, pain management and surgical ICU, Cairo University.
Role Name Email Phone Street address
Principal Investigator Mohamed Selim mohamedahmedselim@cu.edu.eg +201001430841 4th touristic area, building 88, 6 October City
City Postal code Country Position/Affiliation
Giza 12591 Egypt Lecturer of Anesthesia, pain management and surgical ICU, Cairo University.
Role Name Email Phone Street address
Public Enquiries Mohamed Selim mohamedahmedselim@cu.edu.eg +201001430841 4th touristic area, building 88, 6 October City
City Postal code Country Position/Affiliation
Giza 12591 Egypt Lecturer of Anesthesia, pain management and surgical ICU, Cairo University.
Role Name Email Phone Street address
Scientific Enquiries Mohamed Selim mohamedahmedselim@cu.edu.eg +201001430841 4th touristic area, building 88, 6 October City
City Postal code Country Position/Affiliation
Giza 12591 Egypt Lecturer of Anesthesia, pain management and surgical ICU, Cairo University.
REPORTING
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