Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair

Kafrelsheikh University

Status and phase: Enrolling; Phase 4

Conditions: Pediatrics; Magnesium Sulphate; Dexmedetomidine; Ketamine; Hypospadias; Preemptive Analgesia

Treatments: Drug: Dexmedetomidine; Drug: Ketamine; Drug: Magnesium sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT05837000

MKSU 51- 2 - 16

Details and patient eligibility

About

Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.

Enrollment: 75 estimated patients

Sex: Male

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 1-7 years
• American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair.

Exclusion criteria

• Developmental delay
• Psychological or neurological disorders
• Difficult airway
• Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

75 participants in 3 patient groups

Dexmedetomidine

Experimental group

Description:

0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally

Treatment:

Drug: Dexmedetomidine

Ketamine

Experimental group

Description:

0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally

Treatment:

Drug: Ketamine

Magnesium sulphate

Experimental group

Description:

0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.

Treatment:

Drug: Magnesium sulphate