drugset / Trial / NCT06274333

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

NCT06274333

Phase 3 Recruiting 60 enrolled Al-Azhar University Benha University · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2024-02-28
Primary completion
2026-08-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 10 mg/kg
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg
Comparator Tramadol Other / unclassified 1 mg/kg

Indications