Considering that the amount of opioid needed to control pain varies from patient to patient, it is often recommended that physicians individualize care by titrating these drugs based on their analgesic effect. While this approach can be effective in some settings, the crowded conditions of most EDs in the United States are not conducive to fully individualized pain treatment. Further complicating the issue is that pain perception is highly subjective and does not necessarily correlate to scores on tests for pain.

In previous work, Andrew K. Chang, MD, MS, and colleagues developed a simple hydromorphone protocol that addressed individual differences in response to opioids. Nicknamed the “1+1” protocol, patients are given 1 mg intravenous (IV) hydromorphone and are then asked “do you want more pain medication?” 15 minutes later. If patients say yes, they are given another dose of 1 mg IV hydromorphone. If they say no, patients are not be given any more pain medication. The “1+1” protocol has been shown to be efficacious in studies of non-elderly ED patients with acute severe pain.


Building on Previous Research

Dr. Chang and colleagues had a new study published in Annals of Emergency Medicine in which they extended the “1+1” titration protocol by asking “do you want more pain medication?” a total of four times to each patient at approximately 30-minute intervals. This “1+1+1+1” hydromorphone protocol provided patients with the opportunity to obtain up to 4 mg IV hydromorphone in total during a longer period (up to 4 hours).

“Our goal was to create an easy-to-use and easy-to-remember extended pain titration protocol,” says Dr. Chang. “And we wanted to see if it was effective in the unique setting of a busy ED.” He notes that the study enrolled patients presenting to the ED with acute pain that was severe enough that the treating physician felt an IV opioid was needed to manage it.


Success With a New Protocol

Dr. Chang and colleagues enrolled 207 patients in their study, with 114 receiving 1 mg hydromorphone as the initial dose. The authors administered 2 mg hydromorphone to 78 patients while nine patients received 3 mg and six patients received 4 mg. All but two of the patients achieved satisfactory pain control within 2 to 4 hours, and almost all participants were satisfied with their pain treatment.

Overall, patients achieved sufficient analgesia to the point that they declined further doses, including many with higher pain scores. Patients who requested more opioid had clinically and statistically higher mean pain intensity scores than those who did not at each point (Table). The research team noted that two-thirds of patients reported being “very satisfied” while about one-third reported being “satisfied” with the protocol.

“The most important finding was the success of our protocol,” Dr. Chang says. “Our ‘1+1+1+1’ protocol uses yes/no responses, which are simple and easy to remember. It holds promise for safely providing adequate pain relief to patients with acute severe pain. The protocol repeatedly used a simple, patient-centered pain assessment that had a built-in immediate treatment—an additional dose of pain medication if the patient desired it. It’s a more omnibus measure that reflects patients’ assessment of the balance between pain relief and the undesirable effects of opioid analgesics.”

A surprising finding, Dr. Chang says, was that the protocol did not appear to encourage drug-seeking behavior. “Only two of the 207 patients in our study requested more opioids each of the four times they were asked about it.”


Treat Patients, Not Numbers

Most pain assessment and treatment is based on traditional tools like visual analog scales or the 0-to-10 numeric rating scale (NRS). With the NRS, patients provide clinicians with a number between 0 and 10 regarding the severity of their pain. While this is useful for research-related purposes, a dichotomous patient-centered approach may be more effective.

“Our ‘1+1+1+1’ protocol moves away from treating a number and, instead, encourages treating patients and considering their preferences,” Dr. Chang says. “It invites patients to take into account not only the severity of their pain, but also other clinically relevant considerations. These include common opioid side effects that patients may find more unpleasant than partially attenuated pain, such as nausea and drowsiness.”


Possible Future Research

The study by Dr. Chang and colleagues was performed in an urban academic ED that had a high proportion of Hispanic and African-American patients. “It would be ideal if other researchers could corroborate our results in their own unique patient population mix,” says Dr. Chang. “Many of my colleagues across the country have informed me that they have adopted the ‘1+1’ protocol, which we published several years ago. With this new research, it’s hoped that clinicians will also adopt the ‘1+1+1+1’ protocol to further improve pain management in the ED.”