Evaluation of the Roll of IV Fluids in the Treatment of Renal Colic

Study Overview
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Brief Summary
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A randomised controlled trial to evaluate the role of IV fluids in renal colic.

Detailed Description
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A RCT (Randomized Controlled Trial)to evaluate the role of 0.9% NACL (sodium chloride) IV fluids during an acute renal colic. The 2 arms will include - 2 liters of 0.9% NACL IV fluids with pain killers only pain killers The object is to find out if the IV fluids has any advantage in the care of renal colic. Does it helps to relive the pain? Does the stone eject earlier? Will there be fewer interventions?

Official Title
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Randomized Controlled Trial to Evaluate the Efficiency of IV Fluids in the Treatment of Renal Colic

Conditions
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Renal Colic

Intervention / Treatment
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* Drug: 0.9% Sodium-chloride
* Drug: Placebos
* Drug: Optalgin, Voltaren, Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: above 18 years clinical renal colic a radiological proof (CT,US) to urolithiasis Exclusion Criteria: below 18 years has a contraindication for IV fluids (such as CHF (Congestive Heart Failure)etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Fluids<br>Intervention: 2 liters of 0.9% NaCl IV during the ER stay with pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not | Drug: 0.9% Sodium-chloride<br>* 2 liters of 0.9% NaCl IV fluids<br>Drug: Optalgin, Voltaren, Morphine<br>* Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.<br>|
| Placebo Comparator: Placebo<br>No interventions, Only pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not | Drug: Placebos<br>* 2 liters of 0.9% NaCl bag covered with black bag so the participant could not tell the fluids are not dripping to his vain<br>Drug: Optalgin, Voltaren, Morphine<br>* Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone ejection without intervention | Has the stone ejected without intervention? 1 month after the first visit in the ER (Emergency Room) we will preform an US or CT exam to verified that the stone ejected. If the stone that was seen by the US or CT in the ER is not present after 1 month we will assume it was spontaneously ejected. we would like to find out if there is any differences between the 2 groups in matter of spontaneously stone ejection. (Yes or No) | 1 month | 
| The need for urological intervention | The need for urological intervention. 1 month after the visit in the ER we will check if the patient have gone through urological intervention such as urolithiasis. We would like to find out if there is any difference between the two groups in matter of urological intervention between 1 month after the visit in the ER. (Yes or No) | 0 to 1 month | 
| Pain | Measure the VAS (Visual Analogue pain Score). Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 6 hours of treatment in the ER | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 hour of treatment in the ER | 1 Hour | 
| Pain | Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 month from the first visit in the ER | 1 month |