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Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

Primary Purpose

Acute Renal Colic, Ureteric Stone

Status

Completed

Phase

Phase 4

Locations

Kuwait

Study Type

Interventional

Intervention

Paracetamol

Parecoxib

About this trial

This is an interventional treatment trial for Acute Renal Colic focused on measuring Acute renal colic, Ureteric stone, Selective COX2 inhibitor, Parecoxib, Paracetamol

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Al-Amiri Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Paracetamol

Parecoxib

Arm Description

Patients will receive IV 1 g of Paracetamol

Patients will receive 40 mg of Parecoxib IV

Outcomes

Primary Outcome Measures

The need for rescue analgesia (Morphine)

Patient who had persistent pain

Secondary Outcome Measures

The incidence of adverse effects due to medication used

Assessment of adverse effects of the drug used

Full Information

NCT ID

NCT03704623

First Posted

October 10, 2018

Last Updated

August 26, 2020

Sponsor

Mansoura University

Collaborators

Amiri Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03704623

Brief Title

Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

August 15, 2020 (Actual)

Study Completion Date

August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

Collaborators

Amiri Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Renal Colic, Ureteric Stone

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paracetamol

Arm Type

Active Comparator

Arm Description

Patients will receive IV 1 g of Paracetamol

Arm Title

Parecoxib

Arm Type

Active Comparator

Arm Description

Patients will receive 40 mg of Parecoxib IV

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Other Intervention Name(s)

Perfalgan

Intervention Description

Paracetamol 1g IV

Intervention Type

Drug

Intervention Name(s)

Parecoxib

Other Intervention Name(s)

Dynastat

Intervention Description

Parecoxib 40 mg IV

Primary Outcome Measure Information:

Title

The need for rescue analgesia (Morphine)

Description

Patient who had persistent pain

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

The incidence of adverse effects due to medication used

Description

Assessment of adverse effects of the drug used

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdullatif AL-Terki, MD

Organizational Affiliation

Amiri Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Al-Amiri Hospital

City

Kuwait

Country

Kuwait

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

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