Skip to main content
OpenTrials
Completed

NCT Number: NCT03704623

Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Renal Colic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Renal Colic Signs and Symptoms Ureteral Diseases Ureteric Stone Ureterolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Al-Amiri Hospital

Kuwait City, Kuwait

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paracetamol

Drug

Paracetamol 1g IV

Other names: Perfalgan

Parecoxib

Drug

Parecoxib 40 mg IV

Other names: Dynastat

Primary outcomes

  1. The need for rescue analgesia (Morphine)

    Time frame: 30 minutes

    Patient who had persistent pain

Secondary outcomes

  1. The incidence of adverse effects due to medication used

    Time frame: 24 hours

    Assessment of adverse effects of the drug used

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

  • Amiri Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2018
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.