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Randomized Clinical Trial of an Intravenous Hydromorphone Titration Protocol versus Usual Care for Management of Acute Pain in Older Emergency Department Patients

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Abstract

Background and Objectives

Opioid titration is an effective strategy for treating pain; however, titration is generally impractical in the busy emergency department (ED) setting. Our objective was to test a rapid, two-step, hydromorphone titration protocol against usual care in older patients presenting to the ED with acute severe pain.

Methods

This was a prospective, randomized clinical trial of patients 65 years of age and older presenting to an adult, urban, academic ED with acute severe pain. The study was registered at http://www.clinicaltrials.gov (NCT01429285). Patients randomized to the hydromorphone titration protocol initially received 0.5 mg intravenous hydromorphone. Patients randomized to usual care received any dose of any intravenous opioid. At 15 min, patients in both groups were asked, ‘Do you want more pain medication?’ Patients in the hydromorphone titration group who answered ‘yes’ received a second dose of 0.5 mg intravenous hydromorphone. Patients in the usual care group who answered ‘yes’ had their ED attending physician notified, who then could administer any (or no) additional medication. The primary efficacy outcome was satisfactory analgesia defined a priori as the patient declining additional analgesia at least once when asked at 15 or 60 min after administration of the initial opioid. Dose was calculated in morphine equivalent units (MEU: 1 mg hydromorphone = 7 mg morphine). The need for naloxone to reverse adverse opioid effects was the primary safety outcome.

Results

83.0 % of 153 patients in the hydromorphone titration group achieved satisfactory analgesia compared with 82.5 % of 166 patients in the usual care group (p = 0.91). Patients in the hydromorphone titration group received lower mean initial doses of opioids at baseline than patients in the usual care group (3.5 MEU vs. 4.7 MEU, respectively; p ≤ 0.001) and lower total opioids through 60 min (5.3 MEU vs. 6.0 MEU; p = 0.03). No patient needed naloxone.

Conclusions

Low-dose titration of intravenous hydromorphone in increments of 0.5 mg provides comparable analgesia to usual care with less opioid over 60 min.

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Conflict of interest

Dr. Chang is supported by a grant from the NIA (K23 AG033100-01A2). None of the other authors have any financial or personal conflicts of interest.

Author contributions

Andrew K. Chang created the study concept and design, managed acquisition of subjects, and prepared the manuscript; Polly E. Bijur provided all statistical analyses, and edited the manuscript; Michelle Davitt assisted in data collection and auditing, and edited the manuscript; E. John Gallagaher was involved in the design of the study, and edited the manuscript.

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Correspondence to Andrew K. Chang.

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Chang, A.K., Bijur, P.E., Davitt, M. et al. Randomized Clinical Trial of an Intravenous Hydromorphone Titration Protocol versus Usual Care for Management of Acute Pain in Older Emergency Department Patients. Drugs Aging 30, 747–754 (2013). https://doi.org/10.1007/s40266-013-0103-y

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  • DOI: https://doi.org/10.1007/s40266-013-0103-y

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