Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Ureteric Stone; Acute Renal Colic

Treatments: Drug: Paracetamol; Drug: Parecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT03704623

Parecoxib vs Paracetamol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Paracetamol

Active Comparator group

Description:

Patients will receive IV 1 g of Paracetamol

Treatment:

Drug: Paracetamol

Parecoxib

Active Comparator group

Description:

Patients will receive 40 mg of Parecoxib IV

Treatment:

Drug: Parecoxib