Sterile Water Injections for Relieving Ureterolithiasis Pain

Sterile Water Injections as a Complementary Method for Relieving Ureterolithiasis Pain- a Randomized Controlled Trial

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01412840

Enrollment

Registered

2011-08-09

Start date

2014-01-31

Completion date

2022-12-31

Last updated

2019-04-19

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

Conditions

Pain, Ureterolithiasis

Keywords

Ureterolithiasis, Pain, Complementary, RCT

Brief summary

Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard treatment to yield maximal pain relief, a period during which the patient suffers severe to intolerable pain. It would thus be valuable to further evaluate sterile water injection as a method for achieving rapid relief for this type of pain.

Interventions

OTHERDiclofenac and sterile water injections

The patients in the intervention group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. Patients in this group will also be given four subcutaneous injections of 0.5 ml sterile water at the same segmental level, i. e. the area in which the patient reports the pain.

OTHERDiclofenac and isotonic saline

The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac They will also be given four subcutaneous injections of isotonic saline at the same segmental level, i. e. the area in which the patient reports the pain.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Ureterolithiasis pain, acute onset, * Requires pain relief, * Standard treatment prescribed, * Age 18-60, * Ability to understand and follow instructions

Exclusion criteria

* Other administration of NSAID for analgesia 12 hours prior to intervention, * Pregnancy with obstructed flow of urine

Design outcomes

Primary

Measure	Time frame	Description
Change in experience of pain	VAS before treatment and 1,5,10,15,20,30,60,90 and 12o minutes after treatment	Measurement tool: Visual Analogue Scale (VAS)

Secondary

Measure	Time frame	Description
Requirement for additional pain relief	Reported in the protocol up to two hours after treatment	The staff will reporter if any additional pain relief treatment have been used

Countries

Sweden

Outcome results

None listed

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