Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

Last updated: August 26, 2020
Sponsor: Mansoura University
Overall Status: Completed

Phase

4

Condition

Colic

Kidney Stones

Acute Pain

Treatment

N/A

Clinical Study ID

NCT03704623
Parecoxib vs Paracetamol
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical signs and symptoms consistent with acute renal colic

Exclusion

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

Total Participants: 200
Study Start date:
May 01, 2019
Estimated Completion Date:
August 15, 2020

Study 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.

Connect with a study center

  • Al-Amiri Hospital

    Kuwait,
    Kuwait

    Site Not Available

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