[display_podcast]
Date: May 12th, 2016
Guest Skeptics: Dr. Tony Seupaul and Dr. Marc Phan. Tony is the Chairman of the Department of Emergency Medicine, University of Arkansas. Marc is a PGY-3 resident in the Emergency Medicine program at the University of Arkansas.
Case: 48 year old man presents to the emergency department complaining of right flank pain radiating to his groin. He states the pain comes in “waves,” and he has associated nausea without vomiting. On exam, he is afebrile and appears very uncomfortable while grabbing his right flank.
Background: We have covered renal colic a number of times on the SGEM. The last time it was a systematic review on tamsulosin from 2012. The SGEM Bottom Line from that episode was: “Tamsulosin is useless in most ED patients with ureteral colic unless their stone size exceeds at least 4mm.”
* SGEM#71: Like a Rolling Kidney Stone
* SGEM#4: Getting Un-Stoned (Renal Colic and Alpha Blockers)
Clinical Question: Does medical expulsive therapy with tamsulosin or nifedipine increase the likelihood of spontaneous stone passage measured by the absence of need for further intervention?
Reference: Pickard et al. Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial. Lancet 2015
* Population: Patients between the age 18-65 undergoing expectant management for single ureteric stone 10mm or less identified by CT
* Excluded: Patients with suspected sepsis, GFR<30, stones >10mm and age >65yrs
* Intervention: Tamsulosin 400µg daily x 4 weeks or nifedipine 30mg daily x 4 weeks
* Comparison: placebo and each other
* Outcome:
* Primary: Need for further treatment to achieve stone clearance in 4 weeks.
* Secondary: Number of days for analgesic use, time to stone passage, and health status between the groups
Author’s Conclusions: “Tamsulosin 400 μg and nifedipine 30 mg are not effective at decreasing the need for further treatment to achieve stone clearance in 4 weeks for patients with expectantly managed ureteric colic.”
Quality Checklist for Randomized Clinical Trials:
* The study population included or focused on those in the ED. Probably
* The patients were adequately randomized. Yes
* The randomization process was concealed. Yes
* The patients were analyzed in the groups to which they were randomized. Yes
* The study patients were recruited consecutively (i.e. no selection bias). Yes
* The patients in both groups were similar with respect to prognostic factors. Yes
* All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Yes
* All groups were treated equally except for the intervention. Yes
* Follow-up was complete (i.e. at least 80% for both groups). Yes
* All patient-important outcomes were considered. Yes
* The treatment effect was large enough and precise enough to be clinically significant. No.
Key Results: 1136 patients were enrolled (378 in the tamsulosin group, 379 in the nifedipine group and 379 in the control group). Mean age was in the low 40’s, 20% women, one-third of patients had a history of stones, two-thirds of stones were in the lower ureter and 75% were <5mm.