Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort
Recruiting
Phase 3
Interventional Study
Percutaneous Nephrolithotripsy (PCNL)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 20 – 50
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Al-Azhar University · Other
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About This Trial
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 w…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age from 20 - 50 years
* ASA (The American Society of Anesthesiologists) I or II,
* undergo percutaneous nephrolithotomy (PCNL)
Exclusion Criteria:
* Patients with history of psychotic illnesses
* Opioid users
* Bladder obstruction,
* Benign prostatic hyperplasia
* Overactiv…
Contacts
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