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.: PACTR201807487797587 Date of Approval: 11/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Caudal dexmedetomedine versus magnesium sulphate added to bupivacaine for caudal block in pediatric infra-umbilical orthopedic surgeries :
Official scientific title Caudal dexmedetomedine versus magnesium sulphate added to bupivacaine for caudal block in pediatric infra-umbilical orthopedic surgeries : randomized controlled study.
Brief summary describing the background and objectives of the trial Caudal block remains fundamental in pediatric anesthetic practice . It is very useful in a wide range of surgical procedures and has proved to have a remarkable safety record, hence, it is considered as the single most important pediatric regional anesthetic technique . But one of the major limitations of the single-injection technique is the relatively short duration of postoperative analgesia . Prolongation of caudal analgesia using single-shot technique has been achieved by the addition of various adjuvants such as opioids, which significantly prolonging the duration of the block, but was associated with several side effects especially respiratory depression . Caudal Ketamine also provided prolonged postoperative analgesia, but it's potential neurotoxicity has limited its clinical use . Midazolam , neostigmine and tramadol have caused high incidence of postoperative sedation and nausea and vomiting respectively . Dexmedetomidine (Dex), a highly selective α2-adrenoreceptor agonist which offers a unique pharmacological profile with sedation, sympatholysis, analgesia, cardiovascular stability and with great advantage to avoid respiratory depression. It is used as an adjunctive agent for sedation and analgesia in pediatric patients in the critical care unit and for sedation during non-invasive procedures in radiology. It also has a potential role as part of anesthesia care to prevent emergence delirium and post anesthesia shivering sedation in various clinical settings and shows an anesthetic-sparing effect . It has been used as an adjuvant to caudal block to prolong its action for postoperative analgesia . Magnesium has analgesic and antinociceptive effects in human . These effects are primarily based on the regulation of calcium influx into the cells. Magnesium is a physiological calcium antagonist and blocks N-methyl-D-aspartate(NMDA), and such NMDA antagonism prevents the central sensitization from nociceptive stimulation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial pain management after pediatric surgery
Anticipated trial start date 12/07/2018
Actual trial start date
Anticipated date of last follow up 12/09/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group caudal bupivacaine 0.5 ml/kg 0.25% 1,2,6,8,12 hours postoperative caudal bubivacaine 12 Placebo
Experimental Group dexmetedomedine group 2microgram/kg 1,2,6,8,12 hours caudal dexmetedomedine added to bupivacaine 12
Experimental Group magnesium group 50mg 1,2,6,8,12 hours postoperative caudal magnesium added to bupivacaine 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. Age between 1 - 7 years old. b. American Society of Anesthesiologist (ASA) physical status class I- II. c. Patients scheduled for infra-umbilical orthopedic surgeries. a. Patients with known allergy to the study drugs. b. Suspected coagulopathy. c. Infection at the site of caudal block d. History of developmental delay or neuromuscular disorders. e. Skeletal deformities. f. Patients on magnesium therapy Preschool Child: 2 Year-5 Year 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 12/02/2018 research ethics comitte cairouniversity faculity of medicine
Ethics Committee Address
Street address City Postal code Country
kasr alaini manial cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • To evaluate the effect of dexmetedomidine in comparison to magnesium sulphate on duration of bupivacaine caudal block. 1,2,6,8,12 hours postoperative
Secondary Outcome To evaluate the difference between dexmetedomidine and magnesium as an adjuvant in caudal block in hemodynamics(MBP,HR) and post operative pain intensity(FLACC score). every 15 minutes intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
aboelrish hospital kasr elainin cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor kasr alaini kasr alaini street manial cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hagar refaee bibo_gogo12@yahoo.com 01063949855 haram-cairo
City Postal code Country Position/Affiliation
cairo Egypt assisstant lecturer
Role Name Email Phone Street address
Principal Investigator amel aboelella dr_amel@hotmail.com 01223119480 cairo
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Scientific Enquiries mai ali mai_ahmed_ali244@yahoo.com 01005850436 haram
City Postal code Country Position/Affiliation
cairo Egypt lecturer
Role Name Email Phone Street address
Principal Investigator maha gamil mahagamil@hotmail.com 01227342966 cairo
City Postal code Country Position/Affiliation
cairo Egypt professor
Role Name Email Phone Street address
Public Enquiries amira elkhateeb amira_khateeb@yahoo.com 01223955087 cairo
City Postal code Country Position/Affiliation
cairo Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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