NCT03261921

Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery

Adjuncts to Caudal Block in Pediatrics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Male
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

Summary

One of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. Its main disadvantage remains the short duration of action. Hence, different additives have been used. Dexmedetomidine as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so is dexamethasone. The investigators aimed to study the effect of combining both additives in the duration of analgesia, decreasing side effects and decreasing anesthetic doses

Detailed description

Sixty three children scheduled for hypospadias randomized into 3 groups. Group I (n=21) (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group II(n=21)( dexmedetomidine 0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and groupIII(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine 0.25%).intraoperative and postoperative hemodynamics were recorded. In PACU, MOPS scores and sedation scores were recorded at 30min,1,2,3,6and 12hrs. Also the time of first analgesic request was recorded.

Conditions

• Caudal Block

Interventions

Type	Name	Description
DRUG	Dexamethasone	Dexamethasone is used peri -operatively mainly to prevent nausea and vomiting. Also epidural administration of dexamethasone prolong the postoperative analgesia and reduce analgesic needs
DRUG	Dexmedetomidine	Dexmedetomidine is an alpha 2 agonist which has sedative ,analgesic, opioid sparing effect and was proved to prolong the duration of postoperative analgesia when added to local anesthetics
DRUG	Bupivacaine	local anesthetic agent

Timeline

• Start date: 2016-06-05
• Primary completion: 2017-06-22
• Completion: 2017-07-07
• First posted: 2017-08-25
• Last updated: 2017-08-25