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.: PACTR201907535888819 Date of Approval: 22/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Pregabalin Versus Midazolam Premedication on the Anesthetic and Analgesic Requirements in Pediatric Day-Case Surgery
Official scientific title Effect of Pregabalin Versus Midazolam Premedication on the Anesthetic and Analgesic Requirements in Pediatric Day-Case Surgery
Brief summary describing the background and objectives of the trial Midazolam and pregabalin are used safely as premedicant drugs in pediatrics in day-case surgery and both have their effects on anesthetic and analgesic requirements and this study provides a comparison of the effects of both drugs on anesthetic and analgesic requirements of pediatric patients undergoing pediatric day-case surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/07/2019
Actual trial start date
Anticipated date of last follow up 28/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Oral midazolam 0.75 mg/kg 30 min. before anesthetic induction Midazolam syrup (0.75 mg/kg) was prepared by the pharmacist in 5 ml volume and given orally to the patient 30 min. before anesthetic induction 30 Uncontrolled
Experimental Group Oral Pregabalin 5 mg/kg 30 min. before anesthetic induction Pregabalin syrup (5 mg/kg) was prepared by the pharmacist in 5 ml volume and given to the patient orally 30 min before anesthetic induction. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pediatric patients aged 6 months to 6 years scheduled for day case surgery ASA status I or II patients Mental retardation or developmental delay that make pain assessment difficult Hypersensitivity to the study medications Use of psychiatric medications Hyperactivity disorders. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 6 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 02/06/2019 Faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
Abbasia Cairo Egypt Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anesthetic and analgesic consumption, the time to first analgesia in minutes, analgesic doses (oral acetaminophen and rectal diclofenac) required during the first 12 hrs. postoperatively 30 min, 2, 4, 6, 8 and 12 hrs. postoperatively
Secondary Outcome Ramsay sedation score Before premedication and 30 min. after premedication
Secondary Outcome Pediatric Anesthesia Emergence Delirium Scale 10, 20, 30 min postoperatively
Secondary Outcome FLACC score Upon arrival to PACU and every 2 hours after till discharge from hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals Faculty of medicine Ain shams university Abbasia 38 Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sahar Mohamed Talaat Taha Abbasia 38 Cairo 11591 Egypt
Hanaa Mohamed Abd Allah El Gendy Abbasia 38 Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ain shams university Abbasia 38 Cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hanaa Mohamed Abd Allah El Gendy Abbasia 38 Cairo 11591 Egypt
Sahar Mohamed Talaat Taha Abbasia 38 Cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sahar Talaat saharta2000@hotmail.com +201001240236 Abbasia 38
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Associate professor of anesthesiology Faculty of Medicine Ain shams university
Role Name Email Phone Street address
Public Enquiries Sahar Talaat saharta2000@hotmail.com +201001240236 Abbasia 38
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Associate professor of anesthesiology Faculty of Medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Hanaa Elgendy hanaa.elgendy@yahoo.com +201001029544 Abbasia 38
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Associate professor of anesthesiology Faculty of Medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Excel sheet Statistical Analysis Plan Twelve months Editors of the journal to be submitted to
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available 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