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

Sheba Medical Center

Status and phase: Withdrawn; Phase 4

Conditions: Renal Colic

Treatments: Drug: Optalgin, Voltaren, Morphine; Drug: Placebos; Drug: 0.9% Sodium-chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03529097

SHEBA-18-4262-NK-CTIL

Details and patient eligibility

About

A randomised controlled trial to evaluate the role of IV fluids in renal colic.

Full 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 -

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?

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Fluids

Active Comparator group

Description:

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

Treatment:

Drug: 0.9% Sodium-chloride

Drug: Optalgin, Voltaren, Morphine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos

Drug: Optalgin, Voltaren, Morphine