To investigate whether the addition of
phloroglucinol to
parecoxib could improve the efficacy in patients with
acute renal colic. Patients of
acute renal colic were randomly allocated to receive intravenous
Parecoxib 40 mg plus placebo or
Parecoxib 40 mg plus
phloroglucinol 80 mg, respectively.
Pain intensity was recorded using a visual analog scale (VAS) before
drug administration and 5, 15, 30, 60, and 120 min
after treatment start. The primary outcome was the mean
pain intensity difference (PID) at each checkpoint and the effectiveness of drugs (≥ 50 % decrease in VAS score at the end checkpoint). The need for rescue
analgesics and the incidence of adverse effects were considered as secondary outcome of the study. Among 236 patients enrolled in the study, 119 patients received intravenous
parecoxib plus placebo and 114 patients received intravenous
parecoxib plus
phloroglucinol, the remaining 3 patients given up treatment. Baseline demographics were similar between two groups. There are significant differences in the PID at 15 and 30 min between two groups (P15 min = 0.011, P30 min = 0.013). Rescue
analgesics were required by 17 patients (14.3 %) receiving
parecoxib, 7 patients (6.1 %) receiving
parecoxib plus
phloroglucinol (P = 0.041). There were no differences in PID at other checkpoints between two groups, as well as in the incidence of adverse events and the
drug effectiveness.
Parecoxib in combination with
phloroglucinol for
acute renal colic has a faster action, also reduces the demand of rescue
analgesics.