Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic
Phase 4
Completed
- Conditions
- Acute Renal ColicUreteric Stone
- Interventions
- Registration Number
- NCT03704623
- Lead Sponsor
- Mansoura University
- Brief Summary
This study will be conducted to compare the efficacy and safety of Parecoxib versus Paracetamol for treatment of acute renal colic due to ureteric stones.
- Detailed Description
Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive IV 1 g of Paracetamol while group 2 patients will receive 40 mg of Parecoxib IV.
The Visual Analogue Scale (VAS) will be calculated on presentation and at 30 minutes after analgesia administration. Patients who do not respond to an initial dose of the analgesia will receive rescue analgesia in the form of Morphine, 01.mg/kg, IV.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Clinical signs and symptoms consistent with acute renal colic
Exclusion Criteria
- Hypersensitivity to either Paracetamol or Parecoxib.
- History of peptic ulcer.
- Pregnant or breastfeeding females.
- Patients with hepatic impairment (Child-Pugh score >10).
- Patients with chronic kidney disease (CKD) Stage 4 or 5 (eGFR <30mls/min).
- History of coronary ischemia, peripheral vascular or cerebrovascular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paracetamol Paracetamol Patients will receive IV 1 g of Paracetamol Parecoxib Parecoxib Patients will receive 40 mg of Parecoxib IV
- Primary Outcome Measures
Name Time Method The need for rescue analgesia (Morphine) 30 minutes Patient who had persistent pain
- Secondary Outcome Measures
Name Time Method The incidence of adverse effects due to medication used 24 hours Assessment of adverse effects of the drug used
Trial Locations
- Locations (1)
Al-Amiri Hospital
🇰🇼Kuwait, Kuwait