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.
Similar content being viewed by others
References
Cavalieri TA. Pain management in the elderly. J Am Osteopath Assoc. 2002;102(9):481–5.
McCarberg BH. Introduction. Pain and the elderly. Clin J Pain. 2004;20(4):205–6.
Blanda MP. Pharmacologic issues in geriatric emergency medicine. Emerg Med Clin North Am. 2006;24(2):449–65, viii.
Chang AK, Bijur PE, Davitt M, et al. Randomized clinical trial comparing a patient-driven titration protocol of intravenous hydromorphone with traditional physician-driven management of emergency department patients with acute severe pain. Ann Emerg Med. 2009;54(4):561–7 e2.
Callahan CM, Unverzagt FW, Hui SL, et al. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002;40(9):771–81.
Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003;10(4):390–2.
Bijur PE, Kenny MK, Gallagher EJ. Intravenous morphine at 0.1 mg/kg is not effective for controlling severe acute pain in the majority of patients. Ann Emerg Med. 2005;46(4):362–7.
Birnbaum A, Esses D, Bijur PE, et al. Randomized double-blind placebo-controlled trial of two intravenous morphine dosages (0.10 mg/kg and 0.15 mg/kg) in emergency department patients with moderate to severe acute pain. Ann Emerg Med. 2007;49(4):445–53, 453.e1–2.
Aubrun F, Langeron O, Quesnel C, et al. Relationships between measurement of pain using visual analog score and morphine requirements during postoperative intravenous morphine titration. Anesthesiology. 2003;98(6):1415–21.
Galinski M, Dolveck F, Borron SW, et al. A randomized, double-blind study comparing morphine with fentanyl in prehospital analgesia. Am J Emerg Med. 2005;23(2):114–9.
Chang AK, Bijur PE, Napolitano A, et al. Two milligrams i.v. hydromorphone is efficacious for treating pain but is associated with oxygen desaturation. J Opioid Manag. 2009;5(2):75–80.
Hardman JG, Limbird LE, Gilman AG. Goodman & Gilman’s the pharmacological basis of therapeutics. 10th ed. New York: McGraw-Hill Professional; 2001.
Wilson E. Probable inference, the law of succession, and statistical inference. J Am Stat Assoc. 1927;22:209–12.
Leon RV. The concept of the confidence interval for the mean. http://web.utk.edu/~leon/stat201/Confidence%20Interval%20Concept.html (cited 19 Apr 2012).
Chang AK, Bijur PE, Gallagher EJ. Randomized clinical trial comparing the safety and efficacy of a hydromorphone titration protocol to usual care in the management of adult emergency department patients with acute severe pain. Ann Emerg Med. 2011;58(4):352–9.
Chang AK, Bijur PE, Lupow J, et al. Randomized clinical trial of efficacy and safety of a single 2 mg IV dose of hydromorphone vs. usual care in the management of acute pain. Acad Emerg Med. 2013;20:185–92.
Federman AD, Litke A, Morrison RS. Association of age with analgesic use for back and joint disorders in outpatient settings. Am J Geriatr Pharmacother. 2006;4(4):306–15.
Jones JS, Johnson K, McNinch M. Age as a risk factor for inadequate emergency department analgesia. Am J Emerg Med. 1996;14(2):157–60.
Hwang U, Richardson LD, Harris B, et al. The quality of emergency department pain care for older adult patients. J Am Geriatr Soc. 2010;58(11):2122–8.
Platts-Mills TF, Esserman DA, Brown DL, et al. Older US emergency department patients are less likely to receive pain medication than younger patients: results from a national survey. Ann Emerg Med. 2012;60(2):199–206.
Greenwald DA. Aging, the gastrointestinal tract, and risk of acid-related disease. Am J Med. 2004;117 Suppl 5A:8-S–13-S.
Forchheimer MB, Richards JS, Chiodo AE, et al. Cut point determination in the measurement of pain and its relationship to psychosocial and functional measures after traumatic spinal cord injury: a retrospective model spinal cord injury system analysis. Arch Phys Med Rehabil. 2011;92(3):419–24.
Chang AK, Bijur PE, Baccelieri A, et al. Efficacy and safety profile of a single dose of hydromorphone compared with morphine in older adults with acute, severe pain: a prospective, randomized, double-blind clinical trial. Am J Geriatr Pharmacother. 2009;7(1):1–10.
Chang AK, Bijur PE, Campbell CM, et al. Safety and efficacy of rapid titration using 1 mg doses of intravenous hydromorphone in emergency department patients with acute severe pain: the “1+1” protocol. Ann Emerg Med. 2009;54(2):221–5.
Chang AK, Bijur PE, Meyer RH, et al. Safety and efficacy of hydromorphone as an analgesic alternative to morphine in acute pain: a randomized clinical trial. Ann Emerg Med. 2006;48(2):164–72.
Todd KH, Ducharme J, Choiniere M, et al. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007;8(6):460–6.
Todd KH, Lee T, Hoffman JR. The effect of ethnicity on physician estimates of pain severity in patients with isolated extremity trauma. JAMA. 1994;271(12):925–8.
Todd KH, Samaroo N, Hoffman JR. Ethnicity as a risk factor for inadequate emergency department analgesia. JAMA. 1993;269(12):1537–9.
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.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
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
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40266-013-0103-y