Sterile Water Injections for Relieving Ureterolithiasis Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Ureterolithiasis, Pain

Intervention / Treatment
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* Other: Diclofenac and sterile water injections
* Other: Diclofenac and isotonic saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard care and sterile water injections<br>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. | Other: Diclofenac and sterile water injections<br>* 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.<br>|
| Placebo Comparator: Standard care and isotonic saline<br>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. | Other: Diclofenac and isotonic saline<br>* 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.<br>|
| No Intervention: Standard care<br>The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Ureterolithiasis, Pain, Complementary