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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Ketamine
* Drug: Magnesium sulphate


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally | Drug: Dexmedetomidine<br>* Patient will receive 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally<br>|
| Experimental: Ketamine<br>0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally | Drug: Ketamine<br>* Patient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally<br>|
| Experimental: Magnesium sulphate<br>0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally. | Drug: Magnesium sulphate<br>* Patient will receive 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| The incidence of adverse effects | Hypotension bradycardia, respiratory depression and vomiting will be recorded. | 24 hours postoperatively |