Using Dexmedetomidine, Ketamine, and Magnesium for Pain Relief in Children Undergoing Hypospadias Surgery
Role of Adding Dexmedetomidine, Ketamine and Magnesium Sulphate to Caudal Block as Preemptive Analgesia in Hypospadias Repair in Pediatrics: a Randomized Double-blinded Trial
This study tests if a mix of three medications can help reduce pain for young children having surgery to fix hypospadias.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | Male |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr Ash Shaykh, Karelsheikh) |
| Trial ID | NCT05837000 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a combination of dexmedetomidine, ketamine, and magnesium sulfate administered via caudal block for providing preemptive analgesia in pediatric patients undergoing hypospadias repair. The approach aims to enhance pain management during and after surgery, potentially improving recovery outcomes. The study focuses on children aged 1 to 7 years who are classified as ASA I or II, ensuring a safe and controlled environment for the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1-7 years who are classified as ASA I or II and are scheduled for hypospadias repair.
Not a fit: Patients with developmental delays, psychological or neurological disorders, or those with contraindications for caudal block will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and recovery for children undergoing hypospadias repair.
How similar studies have performed: While the specific combination of dexmedetomidine, ketamine, and magnesium sulfate in this context may be novel, similar approaches using caudal blocks for pain management in pediatric surgery have shown promise in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Kafr Ash Shaykh, Karelsheikh
- Karelsheikh University Hospital — Kafr Ash Shaykh, Karelsheikh, Egypt (Recruiting)
Study contacts
- Principal investigator: Kafrelsheikh University — Research ethics committee - Kafrelsheikh University
- Study coordinator: Gamal MD Hendawy Shams, MD
- Email: gamal.shams@yahoo.com
- Phone: 00201095927971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.