Abstract
Objective. To evaluate the efficacy and tolerability of a fixed-dose combination of dexketoprofen and dicyclomine (DXD) injection in patients with acute renal colic. Patients and Methods. Two hundred and seventeen patients were randomized to receive either DXD (n = 109) or fixed-dose combination of diclofenac and dicyclomine injection (DLD; n = 108), intramuscularly. Pain intensity (PI) was self-evaluated by patients on visual analogue scale (VAS) at baseline and at 1, 2, 4, 6, and 8 hours. Efficacy parameters were proportion of responders, difference in PI (PID) at 8 hours, and sum of analogue of pain intensity differences (SAPID). Tolerability was assessed by patients and physicians. Results. DXD showed superior efficacy in terms of proportion of responders (98.17% versus 81.48; P < 0.0001), PID at 8 hours (P = 0.002), and SAPID0–8 hours (P = 0.004). The clinical global impression for change in pain was significantly better for DXD than DLD. The incidence of adverse events was comparable in both groups. However, global assessment of tolerability was rated significantly better for DXD. Conclusion. DXD showed superior efficacy and tolerability than DLD in patients clinically diagnosed to be suffering from acute renal colic.
Highlights
Acute renal colic (ARC) is a common emergency condition mimicking acute abdominal or pelvic condition
The objective of this study was to compare the efficacy and tolerability of Fixed dose of combinations (FDC) of dexketoprofen and dicyclomine IM injection (DXD) with FDC of diclofenac and dicyclomine IM injection (DLD) in the treatment of patients clinically diagnosed to be suffering from ARC
The clinical diagnosis of acute renal colic was found to be consistent with the radiological diagnosis of renal calculus in about 65% patients in both groups
Summary
Acute renal colic (ARC) is a common emergency condition mimicking acute abdominal or pelvic condition. 12% of the population is likely to suffer from ureteric colic sometime in their lifetime and recurrence rates can approach about 50% [1]. It is extremely important to relieve the excruciating pain associated with this condition and. The severe pain of ARC is due to increasing wall tension in the urinary tract as a result of obstruction of the urinary flow. The rising pressure in renal pelvis stimulates release of prostaglandins that cause vasodilatation. This leads to diuresis and further increase in the intrapelvic pressure. Prostaglandins lead to ureteric spasm that further amounts to pain [2, 3]
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