1. Both 10 and 20 mgs of IV ketorolac were found to be non-inferior to 30 mg IV for the emergency pain management of renal colic.
2. The rate adverse effects across the three cohorts was found to be similar.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Renal colic is commonly encountered in the emergency department, and appropriate strategies for pain control that do not rely on opiates are of the essence. In particular, the nonsteroidal anti-inflammatory drug (NSAID) ketorolac has been shown to be as effective as opiates for pain management of renal colic; the current FDA recommended dose for emergency pain control is 30 mg IV. Ketorolac, as with other NSAIDs, is not without a risk of adverse effects, however. As such, this non-inferiority trial compared the efficacy and adverse effects of three doses of ketorolac – 30, 20, and 10 mg IV – for the management of renal colic.
Patients with severe flank or abdominal pain were included if considered to be experiencing renal colic according to provider gestalt. Patients were randomized 1:1:1. The primary outcome was the alleviation of pain as measured by the visual analogue scale (VAS), a 100 mm horizontal line with two points of “no pain” and “the worst possible pain” at either end. Secondary endpoints included pain reduction at 15-, 45-, and 60-minutes following injection, the rate of adverse effects, and the need for additional analgesia at 30-minutes. It was found that all three cohorts had a significant response to ketorolac (p < 0.001). In the non-inferiority analysis, the 10 and 20 mg doses of ketorolac were found to be non-inferior to the 30 mg dose. Furthermore, the need for additional analgesia at 30-minutes was similar across the three cohorts (p = 0.775). The most common side effects included nausea and vomiting, with similar frequencies across the three cohorts. There was a non-significant trend toward fewer side effects of any kind in the 10 mg cohort.
A particular strength of this study is its double-blinded, randomized design to minimize bias. A limitation is that the diagnosis of renal colic was based on provider gestalt; some patients included in the analysis did not undergo CT to confirm the diagnosis. It should be noted, however, that no patients included in the analysis were discharged with a different diagnosis. In all, this non-inferiority trial suggests that a lower dose of 10 mg ketorolac IV is adequate for emergency pain control among patients presenting with renal colic.
In-depth [randomized, non-inferiority trial]: A total of 165 patients were included in the analysis, 55 in the 10 mg cohort (mean [SD] age = 40.38 [10.82] years, 74.5% male), 55 in the 20 mg cohort (mean [SD] age = 39.18 [9.17] years, 80.0% male), and 55 in the 30 mg cohort (mean [SD] age = 41.64 [9.82] years, 69.1% male). Among patients in the 30 mg cohort, the median VAS score at 30-minutes was improved from 90 mm at baseline to 40 mm. Similarly, the improvement was from 80 to 40 mm and from 90 to 40 mm among the 20 mg and 10 mg cohorts, respectively. The non-inferiority limit was previously determined to be 15 mm higher than the mean VAS; because the 95% confidence intervals for the 10 mg and 20 mg cohorts never passed the inferiority limit, these lower doses were found to be non-inferior.
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