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
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.
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). |
Country | Name | City | State |
---|---|---|---|
Egypt | Karelsheikh University Hospital | Kafr Ash Shaykh | Karelsheikh |
Lead Sponsor | Collaborator |
---|---|
Kafrelsheikh University |
Egypt,
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 |
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