Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

NCT ID: NCT03704623

Last Updated: 2020-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-08-15

Brief Summary

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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

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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.

Conditions

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Acute Renal Colic Ureteric Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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Paracetamol

Patients will receive IV 1 g of Paracetamol

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Paracetamol 1g IV

Parecoxib

Patients will receive 40 mg of Parecoxib IV

Group Type ACTIVE_COMPARATOR

Parecoxib

Intervention Type DRUG

Parecoxib 40 mg IV

Interventions

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Paracetamol

Paracetamol 1g IV

Intervention Type DRUG

Parecoxib

Parecoxib 40 mg IV

Intervention Type DRUG

Other Intervention Names

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Perfalgan Dynastat

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amiri Hospital

OTHER_GOV

Sponsor Role collaborator

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed R. EL-Nahas

Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdullatif AL-Terki, MD

Role: STUDY_CHAIR

Amiri Hospital

Locations

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Al-Amiri Hospital

Kuwait City, , Kuwait

Site Status

Countries

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Kuwait

Other Identifiers

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Parecoxib vs Paracetamol

Identifier Type: -

Identifier Source: org_study_id

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