NCT06274333

Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort

The Effect of Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort: A Randomized, Triple-Blind Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia.

Conditions

• Percutaneous Nephrolithotripsy (PCNL)

Interventions

Type	Name	Description
DRUG	Dexmedetomidine 0.5 mic/kg	Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg,
DRUG	Tramadol 1mg/kg	Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.
DRUG	Paracetamol 10mg/kg	Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg. Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.

Timeline

• Start date: 2024-02-28
• Primary completion: 2026-08-30
• Completion: 2026-09-30
• First posted: 2024-02-23
• Last updated: 2026-01-06

Locations

1 site across 1 country: Egypt