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

Phase 4

Recruiting

• Conditions: Dexmedetomidine; Ketamine; Hypospadias; Pediatrics; Preemptive Analgesia; Magnesium Sulphate
• Interventions: Drug: Dexmedetomidine; Drug: Ketamine; Drug: Magnesium sulphate

• Registration Number: NCT05837000
• Lead Sponsor: Kafrelsheikh University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-05-01
• Study Start: 2023-05-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-10
• Last Update Posted: 2023-06-13
• Primary Completion: 2024-10-25
• Study Completion: 2024-10-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 75

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
Ketamine	Ketamine	0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
Magnesium sulphate	Magnesium sulphate	0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.

Primary Outcome Measures

Name	Time	Method
First time of rescue analgesia requirement	24 hours postoperatively	If the FLACC score is ≥ 4, pethidine 1 mg/kg. The first time to require analgesia will be calculated (the time from caudal block to the first time to pethidine injection).

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse effects	24 hours postoperatively	Hypotension bradycardia, respiratory depression and vomiting will be recorded.
Pain score	24 hours postoperatively	FLACC scale will used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain
Total consumption of rescue analgesia	24 hours postoperatively	If the FLACC score is ≥ 4, pethidine 1 mg/kg. The total pethidine consumption of patients require analgesia in the first 24 h postoperative will be calculated.

Trial Locations

Locations (1)

Karelsheikh University Hospital; 🇪🇬 Kafr Ash Shaykh, Karelsheikh, Egypt