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

Dexmedetomidine Clinical Trial

Official title:

Role of Adding Dexmedetomidine, Ketamine and Magnesium Sulphate to Caudal Block as Preemptive Analgesia in Hypospadias Repair in Pediatrics: a Randomized Double-blinded Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837000
• Other study ID #: MKSU 51- 2 - 16
• Status: Recruiting
• Phase: Phase 4
• Start date: May 15, 2023
• Est. completion date: October 25, 2024

Study information

• Verified date: June 2023
• Source: Kafrelsheikh University
• Contact: Gamal MD Hendawy Shams, MD
• Phone: 00201095927971
• Email: gamal.shams[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 25, 2024
• Est. primary completion date: October 25, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 7 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dexmedetomidine
• Hypospadias
• Ketamine
• Magnesium Sulphate
• Pediatrics
• Preemptive Analgesia

Intervention

Drug:
• Dexmedetomidine
Patient will receive 0.5 ml/kg bupivacaine 0.25% + 1µg/kg dexmedetomidine caudally
• Ketamine
Patient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally
• Magnesium sulphate
Patient will receive 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.

Locations

Country	Name	City	State
Egypt	Karelsheikh University Hospital	Kafr Ash Shaykh	Karelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First time of rescue analgesia requirement	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).	24 hours postoperatively
Secondary	Total consumption of rescue analgesia	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.	24 hours postoperatively
Secondary	Pain score	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	24 hours postoperatively
Secondary	The incidence of adverse effects	Hypotension bradycardia, respiratory depression and vomiting will be recorded.	24 hours postoperatively