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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03704623

Enrollment

200

Registered

2018-10-15

Start date

2019-05-01

Completion date

2020-08-15

Last updated

2020-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Colic, Ureteric Stone

Keywords

Acute renal colic, Ureteric stone, Selective COX2 inhibitor, Parecoxib, Paracetamol

Brief 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.

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.

Interventions

DRUGParacetamol

Paracetamol 1g IV

DRUGParecoxib

Parecoxib 40 mg IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

The emergency department (ED) nurse will do randomization by drawing one of the sealed closed envelopes that contain the analgesic to be administered.

Intervention model description

Eligible patients will be randomized to one of the two treatment groups.

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026