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.: PACTR201611001854225 Date of Approval: 07/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Adding Dexmedetomidine and Ketamine to Epidural Anesthesia for Lower Urinary Tract Surgeries
Official scientific title THE EFFECT OF ADDING DEXMEDETOMIDINE AND KETAMINE TO EPIDURAL ANESTHESIA FOR LOWER URINARY TRACT SURGERIES
Brief summary describing the background and objectives of the trial Over 20 years ago, a survey reported that 40% of paediatric surgical patients experienced moderate or severe postoperative pain and that 75% had insufficient analgesia. Caudal Anesthesia (CA) is the most widely used regional technique for analgesia for infra-umbilical surgery, especially in neonates, infants, and certain high-risk children. Dexmtedomidine (Dex) and katamin are tow adjuvants used in CA. In this study we compare between Dex. And katamin in CA in long term lower abdominal operations.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Analgesia,Surgery,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2014
Actual trial start date 07/10/2014
Anticipated date of last follow up 08/07/2015
Actual Last follow-up date 18/08/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 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 CB Group 1 ml/kg containing bupivacaine 0.25% diluted in Saline. received caudal solution of total amount of 1 ml/kg containing bupivacaine 0.25% diluted in Saline. 20 Placebo
Experimental Group CD Group 1 ml/kg containing bupivacaine 0.25% plus dexmedetomidine 1µg/kg diluted in saline. received caudal solution of total amount of 1 ml/kg containing bupivacaine 0.25% plus dexmedetomidine 1µg/kg diluted in saline. 20
Experimental Group CK Group 1 ml/kg containing bupivacaine 0.25% plus ketamine 0.5 mg/kg diluted in saline. received caudal solution of total amount of 1 ml/kg containing bupivacaine 0.25% plus ketamine 0.5 mg/kg diluted in saline. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-II physical status. Age 6 months - 3 years Both sexes Scheduled for major pelvi-abdominal surgeries. parent refusal local infection at puncture site history of allergy or hypersensitivity to local anesthetics history of allergy,intolerance, or reaction to dexmetedomedine bleeding diathesis pre-existing neurological or spinal diseases pre-existing skeletal deformities children with uncorrected cardiac lesions and children with heart block liver or renal impairment. 6 Month(s) 3 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 23/07/2014 Anaesthesia Department Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Cairo faculty of medicine Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome CHIPP Score Postoperative CHIPP Score
Secondary Outcome Hemodynamic parameters 5 min before the induction of anesthesia (baseline value), after induction but 5 min before caudal anesthesia, and then every 20 min after caudal anesthesia during operation and every 30 minutes after the end of operation and recovery till the end of 2h after the end of operation and extubation.
Secondary Outcome Number of patients receiving Fentanyl analgesia intra-operative. intraoperative
Secondary Outcome Sedation score post recovery from anaesthesia every 30 min till 2 hours after recovery.
Secondary Outcome Duration of Analgesia The time from caudal block to the first postoperative analgesic administration
Secondary Outcome Duration of motor block Time when the child began to moves his legs.
Secondary Outcome side effects Postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo faculty of medicine Kasr Eleiny st. Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university Gamaa st. Giza 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo faculty of medicine Kasr Eleiny st. Cairo 11562 Egypt Hospital
Secondary Sponsor Cairo university Gamaa st. Giza 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Pediatric surgery department Kasr Eleiny st. Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elsonbaty jijsonbaty@yahoo.com +201097000067 Elharam st
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Ahmed Abd El-Hamid bashaahmad@yahoo.com +201005204130 20 Ezz Eldin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Saad Ibrahim Saad saadibrahim_7@yahoo.com +201223142889 Oman st.
City Postal code Country Position/Affiliation
Giza Egypt Professor
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