Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

Ureteric Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704623
• Other study ID #: Parecoxib vs Paracetamol
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2019
• Est. completion date: August 15, 2020

Study information

• Verified date: August 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Renal Colic
• Colic
• Renal Colic
• Ureteral Calculi
• Ureteric Stone
• Ureterolithiasis

Intervention

Drug:
• Paracetamol
Paracetamol 1g IV
• Parecoxib
Parecoxib 40 mg IV

Locations

Country	Name	City	State
Kuwait	Al-Amiri Hospital	Kuwait

Sponsors (2)

Lead Sponsor	Collaborator
Mansoura University	Amiri Hospital

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The need for rescue analgesia (Morphine)	Patient who had persistent pain	30 minutes
Secondary	The incidence of adverse effects due to medication used	Assessment of adverse effects of the drug used	24 hours