Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic Due to Ureteric Calculi: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Ureteric Stone; Acute Renal Colic
• Intervention / Treatment: Drug: Paracetamol; Drug: Parecoxib

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait, Kuwait
    • AL-Amiri Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paracetamol; Patients will receive IV 1 g of Paracetamol	Drug: Paracetamol; Paracetamol 1g IV; Other Names: Perfalgan
Active Comparator: Parecoxib; Patients will receive 40 mg of Parecoxib IV	Drug: Parecoxib; Parecoxib 40 mg IV; Other Names: Dynastat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for rescue analgesia (Morphine)	Patient who had persistent pain	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of adverse effects due to medication used	Assessment of adverse effects of the drug used	24 hours

Collaborators and Investigators

• Sponsor: Mansoura University
• Collaborators: Amiri Hospital
• Investigators: Study Chair: Abdullatif AL-Terki, MD, Amiri Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Ureteric stone; Paracetamol; Parecoxib; Acute renal colic; Selective COX2 inhibitor
• Additional Relevant MeSH Terms: Urologic Diseases; Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Renal Colic; Colic; Ureteral Calculi; Ureterolithiasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Cyclooxygenase 2 Inhibitors; Acetaminophen; Parecoxib
• Other Study ID Numbers: Parecoxib vs Paracetamol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No