Renal Colic
Conditions
Brief summary
A randomised controlled trial to evaluate the role of IV fluids in renal colic.
Detailed description
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 - 1. 2 liters of 0.9% NACL IV fluids with pain killers 2. 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?
Interventions
2 liters of 0.9% NaCl IV fluids
DRUGPlacebos
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
DRUGOptalgin, Voltaren, Morphine
Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone ejection without intervention | 1 month | 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) |
| The need for urological intervention | 0 to 1 month | 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) |
| Pain | 6 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 1 Hour | 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 |
Outcome results
None listed