Executive Summary

A new study suggests that in a busy emergency environment, a protocol based on simply asking patients if they need more pain medicine at 30-minute intervals can be effective at controlling pain, although some experts urge stricter limits on the automatic authorization of hydromorphone, and a mechanism to keep physicians more involved in care.

• Experts suggest that soliciting patient input is more effective than relying on numbered pain scales to gauge whether pain has been adequately controlled.

• For non-elderly patients in severe pain, the protocol includes an automatic authorization for an additional milligram of hydromorphone up to four times at 30-minute intervals.

• Study results indicate that all but two of 207 study participants achieved satisfactory pain control at one or more points in the study, and that most were satisfied with their treatment.


For years clinicians have relied on numerical rating scales to assess whether patients in severe pain have received adequate relief from analgesic medications. However, many believe it’s a suboptimal approach because numbers mean different things to different patients, and pain tolerance varies widely. Further, some emergency providers view the introduction of pain scales as an unnecessary and burdensome step in a fast-paced environment that leaves little time for individualized pain treatment.

Why not simply ask patients if they need more medicine? It’s a provocative idea, but one that is gaining traction and adherents in one form or another in EDs across the country. What’s more, researchers looking at the use of an evidence-based pain protocol built around this basic concept have found that it is not only effective at achieving pain control, it’s also a winner with emergency patients, although some physicians believe there are limits to how far such protocols should go.

Solicit input from patients

Wanting to create a simple titration protocol tailored to the unique ED environment, researchers at Montefiore Medical Center in Bronx, NY, designed an approach that expanded upon an earlier protocol first published in 2009.1

“In that protocol, all patients received 1 milligram IV hydromorphone followed by an optional second dose,” explains Andrew Chang, MD, MS, FACEP, FAAEM, the lead author of the study and an assistant professor in the Department of Emergency Medicine at Albert Einstein College of Medicine, Montefiore Medical Center. “We then decided to build on that protocol to create the current protocol, which allows for patients to receive up to 4 mg IV hydromorphone over a four-hour time span.”

In the study, non-elderly emergency patients reporting acute severe pain received 1 milligram of IV hydromorphone. After 30 minutes elapsed, the patients were asked whether they wanted more pain medication. If they answered yes, they received another 1 milligram of hydromorphone. This question was asked a total of four times at 30-minute intervals with patients receiving the same 1 milligram dose if they indicated that they needed more pain medication.2

Investigators report that 205 out of 207 patients received satisfactory pain control at one or more points in the study, with no adverse events associated with the hydromorphone. More than half the patients (114) received 1 milligram of hydromorphone, 78% received two doses of the drug, nine patients received three doses, and six received 4 milligrams of the drug.

Only two of the participating patients failed to achieve satisfactory pain control within the study’s duration of two to four hours. Further, the patients gave their treatment for pain decent marks. According to the researchers, 67% reported being very satisfied with their pain treatment in the ED, and 29% reported being satisfied.

To minimize the risk of attracting drug-seekers, investigators used strict inclusion and exclusion criteria, Chang explains.

“A patient couldn’t just request to be in the study,” he says. “We specifically excluded patients with chronic pain syndromes and anyone who had taken an opioid pain medication within the past seven days.”

Such measures were apparently effective. The researchers report that they found no evidence of drug-seeking, and they note that only two out of the 207 participating patients asked for additional opioid medication every time they were queried during the study period.

Chang suggests the approach, which he dubs the 1+1+1+1 protocol, is clearly doable in a busy, urban ED setting.

“The ED where the study was conducted is one of the busiest in the country, so if it can work here, we are confident that it can work anywhere,” he says. “In addition, I hear from colleagues around the country that they are already using the 1 + 1 protocol that we developed several years ago, so I don’t see any reason why clinicians could not also adopt this extended protocol.”

Limit dosing levels

Ross Berkeley, MD, FACEP, the director of quality for Emergency Medicine Physicians, and director of the chest pain center at University Medical Center of Southern Nevada in Las Vegas, NV, sees potential value in using the type of protocol that Chang and colleagues have devised, but what he sees as most important is the way it forces clinicians to continually reassess patients at regular time intervals.

“It is very easy in a busy environment for a patient to potentially get lost in the system, to be forgotten about, or to be given a dose of medicine and never asked, or not asked until they are ready to be discharged, how is their pain,” Berkeley observes. “So just having a system in place where you have to reassess somebody 30 minutes after they received an analgesic and find out whether they are better, worse, or the same — that is the value of the system, whether you choose to use hydromorphone like [the study investigators] or you choose to use morphine or fentanyl.”

However, Berkeley isn’t entirely comfortable with patients being able to receive up to 4 milligrams of hydromorphone without being reassessed by a physician.

“There are a lot of warnings and advisories coming out at the state level regarding potential complications of hydromorphone due to unexpected, delayed effects on respiratory drive,” he warns. “Although I like part of the concept, I don’t like the idea that a patient will receive a large dose of opioids without being reassessed by the physician, because maybe that means he or she is being under-dosed.”

In fact, Berkeley says he would seldom even consider prescribing as much hydromorphone as the protocol allows.

“I work at a level one trauma center — the only level one trauma center in the state. We see more than 12,000 trauma patients a year, and I do many shifts there where I am giving large doses of opioids for everything from fractures and dislocations to significant soft tissue injuries,” he observes. “However, it would be exceedingly unusual for me to give doses in the range of 4 milligrams of hydromorphone.”

If someone required such large doses, Berkeley says he would probably switch the patient to a shorter-acting titratable drug like fentanyl, or he would give the patient ketamine.

“I would consider other methods of synergistically controlling their pain and figure out exactly what is going on,” he explains. “Four milligrams of hydromorphone is roughly worth 30 milligrams of morphine. That is a pretty sizable dose. You might need it for someone with bad burns or a bad kidney stone, but, usually, there is value in considering synergy between different drug classes.”

Consider weight-based adjustments

Berkeley suggests another weakness in the protocol is administering the same standardized dose to every patient regardless of whether they weigh 40 kilograms or 340 kilograms.

“They are all getting 1 milligram of hydromorphone, so having a weight-based system makes a lot more sense,” he says. “It would probably be much more likely to deliver analgesic doses to patients in a more rapid fashion.”

If a patient receives two doses of the same medication and they still haven’t gotten relief, then perhaps they require a different medicine, Berkeley notes.

“Maybe they need to switch to a benzodiazepine or maybe they need some ketamine,” he says. “Maybe there is something else going on with the patient the physician should be involved with because he or she is missing something.”

For instance, Berkeley says a patient could be in a lot of pain because he is suffering from compartment syndrome or necrotizing fasciitis, and the physician has made an incorrect assessment of what is going on with the patient.

“After two doses of medication [patients] should have a bedside reassessment as opposed to an automated order, because this isn’t even a verbal order where the nurse is asking the physician whether she can provide another dose. It is an automatic authorization,” Berkeley notes. “From a patient safety standpoint and just quality of care, you can take this to another level by simply making sure the physicians stay involved in the care a little bit more.”

Berkeley acknowledges having a protocol in place makes sense where there is no physician available or when the goal is to decrease the time it takes to get a drug on board.

“If you’ve got a protocol available in triage, and the nurses know it is going to take an hour before the physician can see the patient, what better way to get the patient comfortable than to have a protocol in place that authorizes the nursing staff to give 0.15 milligrams per kilogram of morphine IV to any patient with a severely painful injury,” he says, noting the authorization for this kind of prescribing should be fine as long as the patient is not allergic to the drug.

However, if a patient is already in a bed and being seen, automatically protocolling drugs in such high doses doesn’t make as much sense, Berkeley adds.

“That is a slippery slope,” he says. “I worry that it could be the beginning of a trend in medicine that may have some downstream effects that we are not prepared to deal with, or that nobody is thinking about.”

Re-think use of pain scales

Nonetheless, Berkeley agrees that simply asking patients about their pain is a superior practice to relying on numbered pain scales.

“You might have a patient with a very low threshold for pain, and to them, they need to be a two or less to be comfortable, whereas I might be happy with a four for myself,” he explains. “A patient reporting an eight out of 10 might say they are fine while another patient who is a six is in agony.”

The numbers on a pain scale may have some utility with documentation or gauging whether a patient’s pain level has improved or declined over time, but Berkeley prefers a more straightforward approach.

“It is much more valuable to just ask patients subjectively how they are feeling, and do they need more medication right now. I think it is a great way to do it,” he says.

Chang also has little use for pain scales when assessing whether a patient needs more medication.

“I think one of the main take-away points from this as well as some of our other studies is to use a patient-centered approach to deciding whether patients’ pain is adequately controlled,” he says.

Chang does have plans for further work in this area. Previously, he developed a similar pain protocol for older adults — a half plus half protocol.

“I am thinking about trying to extend that for older adults just as I did with this protocol for younger adults,” he says.

REFERENCES

  1. Chang AK, et al. Safety and efficacy of rapid titration using 1 mg doses of intravenous hydromorphone in emergency department patients with acute sever pain: The “1 plus 1” protocol. Ann Emerg Med 2009;54:221-225.
  2. Chang AK, et al. Efficacy of an acute pain titration protocol driven by patient response to a simple query: Do you want more pain medication? Ann Emerg Med 2015;doi: http://dx.doi.org/10.1016/j.annemergmed.2015.04.035

SOURCES

  • Ross Berkeley, MD, FACEP, Director, Quality for Emergency Medicine Physicians, and Director, Chest Pain Center, University Medical Center of Southern Nevada in Las Vegas, NV. E-mail: rberkeley@emp.com.
  • Andrew Chang, MD, MS, FACEP, FAAEM, Assistant Professor, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY. E-mail: aching@montefiore.org.