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Dexmedetomidine vs Tramadol with Bupivacaine in Caudal Block for Pediatric Inguinal Hernia
NCT06735443Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2021
- Primary completion
- Apr 2022
- Countries
- 1
- Sponsor
- Sahiwal Medical College
- Modality
- Small Molecules
- Conditions
- postoperative pain
01
Overview
Phase 3, randomised trial in postoperative pain comparing Bupivacaine + Dexmedetomidine with Bupivacaine + Tramadol (2 arms). Primary endpoints: Heart Rate, Mean Arterial Pressure and 2 more. Started Mar 2021; status: completed.
02
Design
2 arms- Study design
- Randomized
Bupivacaine + Dexmedetomidine
0.25% bupivacaine 1 mL/kg + dexmedetomidine 0.5 μg/kg
Bupivacaine + Tramadol
0.25% bupivacaine 1 mL/kg + tramadol 1 mg/kg
03
Who it enrols
Children aged 5-15 years undergoing elective inguinal hernia surgery (ASA I-II) with expected duration <60 minutes. Excludes emergency surgery, infection at injection site, bleeding disorders (PT>15s), developmental delay, sepsis, or neurological/spinal diseases.
04
Endpoints
Primary
Heart Rate
Mean Arterial Pressure
Postoperative Pain Score
Time to First Rescue Analgesia
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