UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040081
Receipt number R000045705
Scientific Title Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.
Date of disclosure of the study information 2020/04/07
Last modified on 2020/06/20 04:35:35

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Basic information

Public title

Treatment of Renal Colic Using intradermal Injection of Sterile Water

Acronym

ARC

Scientific Title

Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.

Scientific Title:Acronym

ISWARC

Region

Asia(except Japan)


Condition

Condition

Acute renal colic

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the intracutaneous injection of sterile water in the treatment of renal colic.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The primary outcome was the improvement in pain intensity using the visual analogue scale at 30min, 45min, and 60min after ISWI ( intradermal sterile water injection), Diclofenac, Placebo injections

Key secondary outcomes

The secondary outcome was the need for rescue analgesia after each modality of therapy.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The control group( 50 patients presented to the emergency department with renal colic) received intracutaneous injections of 0.5cc isotonic saline in the flank once.

Interventions/Control_2

Group A ( 50 patients presented to the emergency department with renal colic) received intracutaneous injections of 0.5 cc sterile water in the most painful area of the flank once.

Interventions/Control_3

Group B ( 50 patients presented to the emergency department with renal colic ) received an intramuscular injection of 75 mg diclofenac in the gluteal region once.

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients presented to the emergency department with acute renal colic, confirmed later on to have ureteral stone on unenhanced Computed tomography (CT scan)

Key exclusion criteria

Patients who had an infection in the area of injection, patients more than 60 years old, patients who have received any analgesic before presentation

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Athanasios
Middle name
Last name Papatsoris

Organization

Sismanoglio Hospital.

Division name

Urology

Zip code

15126

Address

Athens, Greece

TEL

00302132058001

Email

agpapatsoris@yahoo.gr


Public contact

Name of contact person

1st name Mohamad
Middle name
Last name Abou Chakra

Organization

Lebanese University

Division name

Urology

Zip code

1108

Address

Beirut,Lebanon

TEL

009611850040ext.3364

Homepage URL


Email

mohamedabouchakra@hotmail.com


Sponsor or person

Institute

Al Zahraa Hospital, University Medical Center, Urology Department

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Al Zahraa Hospital, University Medical Center

Address

Beirut,Lebanon

Tel

009611850040ext.3366

Email

uro.ul@outlook.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

10.1016/j.ajem.2020.04.079

Number of participants that the trial has enrolled

150

Results

published

Results date posted

2020 Year 04 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 04 Month 29 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 05 Day

Date of IRB

2017 Year 12 Month 12 Day

Anticipated trial start date

2017 Year 12 Month 15 Day

Last follow-up date

2019 Year 12 Month 10 Day

Date of closure to data entry

2019 Year 12 Month 19 Day

Date trial data considered complete

2019 Year 12 Month 20 Day

Date analysis concluded

2020 Year 01 Month 18 Day


Other

Other related information



Management information

Registered date

2020 Year 04 Month 07 Day

Last modified on

2020 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045705


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name