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.: PACTR201710002714125 Date of Registration: 22/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine as an adjuvant to bupivacain in unilateral transversus abdominis plane block in pediatrics
Official scientific title Dexmedetomidine as an adjuvant to bupivacaine in unilateral transversus abdominis plane block in pediatrics
Brief summary describing the background and objectives of the trial present study was designed to compare the efficacy and safety of two different doses of dexmedetomedine as an adjuvant to bubivacaine in unilateral TAP block in pediatric patients undergoing lower abdominal surgery .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2017
Actual trial start date 01/04/2017
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Not yet 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 randomisation using a radomisation table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control (C) 0.3mg /kg 0.5 % isobaric bupivacain, once 24 hours transversus abdominis plane block in pediatrics 30 Placebo
Experimental Group Dexmedetomidine 0.5 ug (D0.5) 0.3mg /kg 0.5 % isobaric bupivacain + 0.5ug/kg Dexmedetomidine, once 24 hours Dexmedetomidine in unilateral transversus abdominis plane block in pediatrics 30
Experimental Group Dexmedetomidine 1ug (D1ug) 0.3mg /kg 0.5 % isobaric bupivacain + 1ug/kg Dexmedetomidine, once 24 hours Dexmedetomidine in unilateral transvesus abdominis plane blocks in pediatric 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients as ASA class I or II , aged from 1-7 years old undergoing any lower abdominal surgery that requires skin incision in one side of midline of the anterior abdominal wall . Participants refusing regional block and those having bleeding disorders, skin lesions or wounds at the site of proposed needle insertion, evidence of peritonitis, septicemia and hepatic disease or enlargement in addition to those who required emergency procedures or operations that requires exploratory longitudinal midline incision were excluded from the study. 1 Year(s) 7 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 31/01/2017 minya university, Faculty of medicine
Ethics Committee Address
Street address City Postal code Country
MAIN ROAD SHALABY LAND minya Minya 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome compare the efficacy of two different doses of dexmedetomedine as an adjuvant to bubivacaine in unilateral TAP block in pediatric patients undergoing lower abdominal surgery ¿ Quality of analgesia will be assessed immediately postoperatively and then at 2, 4, 8, 12 and 24 h postoperatively using FLACC scale
Secondary Outcome compare the safety of two different doses of dexmedetomedine as an adjuvant to bubivacaine in unilateral TAP block in pediatric patients undergoing lower abdominal surgery ¿ Hemodynamic data including heart rate (HR) and mean arterial blood pressure (MAP) ¿ postoperative complication including postoperative hypotention or bradycardia ¿ length of hospital stay and patients or parents satisfaction assessed on a 5-point scale
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
minia university hospital nail Cornish Minia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minya university main road shalaby land Minya 61519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ANESTHESIA AND INTENSIVE CARE DEPARTMENT IN MINYA UNIVERSITY HOSPITAL corniche el-nil EL-Minya l 61519 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed wafdi swesy mohammed 129 college of Literature street shalaby land Minya 61519 Egypt
Amany khairy Abo el-hussein 95 el-Horea street branched from nil cornich Minya 61519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator haidy mansour haidy_mourad@yahoo.com 01221802324 9 elwhda elarabia
City Postal code Country Position/Affiliation
maghagha, minya 61691 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries haidy mansou haidy_mourad@yahoo.com 01221802324 9 elwehda elarabia
City Postal code Country Position/Affiliation
minya 61691 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries haidy mansou haidy_mourad@yahoo.com 01221802324 9 elwehda elarabia
City Postal code Country Position/Affiliation
magagh 61691 Egypt lectruer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information