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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05837000
Enrollment
75
Registered
2023-05-01
Start date
2023-05-15
Completion date
2024-10-25
Last updated
2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGDexmedetomidine

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

DRUGKetamine

Patient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally

DRUGMagnesium sulphate

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

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
1 Years to 7 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
First time of rescue analgesia requirement24 hours postoperativelyIf 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

MeasureTime frameDescription
Total consumption of rescue analgesia24 hours postoperativelyIf 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.
Pain score24 hours postoperativelyFLACC 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
The incidence of adverse effects24 hours postoperativelyHypotension bradycardia, respiratory depression and vomiting will be recorded.

Countries

Egypt

Contacts

Primary ContactGamal MD Hendawy Shams, MD
gamal.shams@yahoo.com00201095927971

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026