2013
DOI: 10.1111/acem.12071
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Randomized Clinical Trial of Efficacy and Safety of a Single 2‐mg Intravenous Dose of Hydromorphone Versus Usual Care in the Management of Acute Pain

Abstract: Objectives: The objective was to test the efficacy and safety of 2 mg of intravenous (IV) hydromorphone (Dilaudid) against "usual care" in emergency department (ED) patients with acute severe pain.Methods: This was a randomized clinical trial. Patients allocated to 2 mg of IV hydromorphone received their medication in a single dose. Those randomized to usual care received any IV opioid, with type, dose, and frequency chosen by the ED attending. All patients received 2 L/min. nasal cannula oxygen. The primary o… Show more

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Cited by 13 publications
(11 citation statements)
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“…Knowledge of the dose and potency of hydromorphone given to the hydromorphone titration group may have influenced ED physicians’ decisions to use higher doses of IV opioids in the usual care group than they may ordinarily use. In addition, we have conducted a series of opioid studies [4, 11, 15, 16, 2325] in our ED such that our attendings are now more comfortable administering higher doses of opioids to patients with acute severe pain. The effect of this potential performance bias would be to underestimate the difference between the hydromorphone titration group and usual care.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…Knowledge of the dose and potency of hydromorphone given to the hydromorphone titration group may have influenced ED physicians’ decisions to use higher doses of IV opioids in the usual care group than they may ordinarily use. In addition, we have conducted a series of opioid studies [4, 11, 15, 16, 2325] in our ED such that our attendings are now more comfortable administering higher doses of opioids to patients with acute severe pain. The effect of this potential performance bias would be to underestimate the difference between the hydromorphone titration group and usual care.…”
Section: Discussionmentioning
confidence: 99%
“…We estimated that a sample size of 160 patients per group would be needed to detect at least a 10% [15, 16] absolute difference in proportion of patients declining additional pain medication when asked, using a 2-tailed alpha of 0.05 and power = 0.80. In order to ensure enrollment of a minimum of 320 patients for analysis, an additional 30 patients (approximately 10%) were enrolled to account for potential protocol violations and missing data.…”
Section: Methodsmentioning
confidence: 99%
“…For categorical variables we used Wilson's method of calculating a 95% CI around differences between proportions. 7 We estimated that a sample size of 148 (74 per group) would be needed to detect a difference of at least 1.3 NRS units in the improvement in NRS pain score between the two study groups, assuming a common SD of 2.8 (based on prior studies we have performed) 8,9 for an alpha of 0.05 and 80% power. A difference of 1.3 NRS units is a previously validated and reproducible measure used to quantify the "minimum clinically significance difference" in change in NRS pain score.…”
Section: Outcome Measuresmentioning
confidence: 99%
“…Part of becoming familiar with a drug is learning what the expected effective dose might be. For morphine it may be twice the usually insufficient 0.15 mg/kg dose, while for hydromorphone it may be a straight forward dose of 2 mg [32]. Whatever the selected drug, clinicians should give the first-choice drug a fair trial before moving to a rescue therapy.…”
Section: Keep It Simplementioning
confidence: 99%