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. 2012:2012:295926.
doi: 10.1155/2012/295926. Epub 2012 Apr 23.

Efficacy and tolerability of fixed-dose combination of dexketoprofen and dicyclomine injection in acute renal colic

A Porwal  1 , A D Mahajan, D S Oswal, S S Erram, D N Sheth, S Balamurugan, V Kamat, R P Enadle, A Badadare, S K Bhatnagar, R S Walvekar, S Dhorepatil, R C Naik, I Basu, S N Kshirsagar, J V Keny, S Sengupta
Affiliations

Efficacy and tolerability of fixed-dose combination of dexketoprofen and dicyclomine injection in acute renal colic

A Porwal et al. Pain Res Treat. 2012.

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 SAPID(0-8 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.

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Figures

Figure 1
Figure 1
Improvements in VAS scores over 8 hours after DXD and DLD injections; unpaired t-test applied for between-group comparison.
Figure 2
Figure 2
Patient-reported clinical global impression for change in pain. Fisher's exact test applied between proportion [(much worse + worse + slightly worse + no change) versus (slightly better + better + much better)].
Figure 3
Figure 3
(a) Patient's global assessment of tolerability, (b) Physician's global assessment of tolerability. Fisher's extract test applied between proportions [(very good + good) versus (fair + unchanged)].
See this image and copyright information in PMC

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