OBJECTIVE: • To assess the efficacy of papaverine hydrochloride combined with a diclofenac sodium suppository to relieve renal colic compared with diclofenac suppository monotherapy, as the effect of phosphodiesterase inhibitors on ureteric muscles might reduce the pain of renal colic. PATIENTS AND METHODS: • A prospective, double-blind clinical study was performed. • In all, 550 patients aged 17-55 years with acute renal colic were randomised to two groups. Patients in one group (group A) received a diclofenac suppository (100 mg) plus saline 0.9% (placebo) and the other group (group B) received a diclofenac suppository (100 mg) plus intravenous (i.v.) papaverine hydrochloride (1.5 mg/kg up to 120 mg). • Pain intensity was assessed using a visual analogue scale (VAS) at 0, 20 and 40 min after treatment. Further analgesia was provided at the patients' request (25 mg pethidine intramuscularly). RESULTS: • Baseline characteristics (sex, age, past history of similar pains) were similar in the two groups. • There were significant differences in VAS pain scores between 0 and 20 min and 0 and 40 min in both groups (P < 0.001). • At the end of study, 71.1% of patients in group A and 90.9% of patients in group B reported pain relief and did not require pethidine, respectively. • Significantly more patients in group A required further analgesia. CONCLUSIONS: • According to our results, i.v. papaverine hydrochloride plus a diclofenac suppository were more effective than the diclofenac suppository alone for treating acute renal colic. • Therefore, i.v. papaverine hydrochloride is a beneficial supplemental therapy to relieve renal colic pain, particularly combined with non-steroidal anti-inflammatory drugs.
RCT Entities:
OBJECTIVE: • To assess the efficacy of papaverine hydrochloride combined with a diclofenac sodium suppository to relieve renal colic compared with diclofenac suppository monotherapy, as the effect of phosphodiesterase inhibitors on ureteric muscles might reduce the pain of renal colic. PATIENTS AND METHODS: • A prospective, double-blind clinical study was performed. • In all, 550 patients aged 17-55 years with acute renal colic were randomised to two groups. Patients in one group (group A) received a diclofenac suppository (100 mg) plus saline 0.9% (placebo) and the other group (group B) received a diclofenac suppository (100 mg) plus intravenous (i.v.) papaverine hydrochloride (1.5 mg/kg up to 120 mg). • Pain intensity was assessed using a visual analogue scale (VAS) at 0, 20 and 40 min after treatment. Further analgesia was provided at the patients' request (25 mg pethidine intramuscularly). RESULTS: • Baseline characteristics (sex, age, past history of similar pains) were similar in the two groups. • There were significant differences in VAS pain scores between 0 and 20 min and 0 and 40 min in both groups (P < 0.001). • At the end of study, 71.1% of patients in group A and 90.9% of patients in group B reported pain relief and did not require pethidine, respectively. • Significantly more patients in group A required further analgesia. CONCLUSIONS: • According to our results, i.v. papaverine hydrochloride plus a diclofenac suppository were more effective than the diclofenac suppository alone for treating acute renal colic. • Therefore, i.v. papaverine hydrochloride is a beneficial supplemental therapy to relieve renal colic pain, particularly combined with non-steroidal anti-inflammatory drugs.