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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care and sterile water injections | Experimental | 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. |
|
| Standard care and isotonic saline | Placebo Comparator | 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. |
|
| Standard care | No Intervention | The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac and sterile water injections | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid Bergh, PhD | University of Skövde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Life Sciences, University of Skövde | Skövde | SE-541 28 | Sweden |
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| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Diclofenac and isotonic saline | Other | 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. |
|
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |