Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

Mansoura University200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Acute Renal Colic Ureteric Stone

Interventions

ParacetamolDRUG

Paracetamol 1g IV

ParecoxibDRUG

Parecoxib 40 mg IV

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Al-Amiri Hospital

Kuwait City, Kuwait

Outcomes

Primary Outcomes

The need for rescue analgesia (Morphine)

Patient who had persistent pain

Time frame: 30 minutes

Secondary Outcomes

The incidence of adverse effects due to medication used

Assessment of adverse effects of the drug used

Time frame: 24 hours

Data from ClinicalTrials.gov

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