drugset / Trial / NCT03791879

Caudal Dexmedetomidine Analgesia in Pediatrics .

NCT03791879

Completed 164 enrolled Mansoura University
RandomizedParallel-groupTriple-blindSupportive care

Summary

Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine \>1 µg/kg could not add more analgesic \& stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression). The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects\& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery.

Timeline

Start
2019-01-01
Primary completion
2020-10-01
Completion
2020-10-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg Other
Comparator Dexmedetomidine Other / unclassified 1 ug/kg Other
Comparator Dexmedetomidine Other / unclassified 1.5 ug/kg Other
Comparator Dexmedetomidine Other / unclassified 2 ug/kg Other
Comparator Levobupivacaine Other / unclassified 0.125 % Other