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

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.

Study Overview

• Status: Recruiting
• Conditions: Ketamine; Dexmedetomidine; Hypospadias; Pediatrics; Preemptive Analgesia; Magnesium Sulphate
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Ketamine; Drug: Magnesium sulphate

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gamal MD Hendawy Shams, MD; Phone Number: 00201095927971; Email: gamal.shams@yahoo.com

Study Locations

• Egypt
  • Karelsheikh
    • Kafr Ash Shaykh, Karelsheikh, Egypt, 33516
      • Recruiting
      • Karelsheikh University Hospital
      • Contact: Gamal H Shams, MD; Phone Number: 00201095927971; Email: gamal.shams@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: Kafrelsheikh University, Research ethics committee - Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): October 25, 2024
• Study Completion (Estimated): October 25, 2024

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Ketamine; Dexmedetomidine; Magnesium Sulfate
• Other Study ID Numbers: MKSU 51- 2 - 16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon Reasonable request from the corresponding author for one year after study completion
• IPD Sharing Time Frame: The data will be available for one year after study completion
• IPD Sharing Access Criteria: The data will be available upon Reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Study Data/Documents

1. Study Protocol
   Information identifier: MKSU 51- 2 _ 16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No