Audio Therapy for Postoperative Pediatric Pain: Randomized Controlled Nonsense

For 10/10 pain, I recommend two Rihannas and a Captain and Tennille

In January of 2015, a study on “the effect of audio therapy to treat postoperative pain in children” performed at Lurie Children’s Hospital and published in Pediatric Surgery International made the media rounds. It was the typical story where numerous news outlets further exaggerated already exaggerated claims made in a university press release, in this case Northwestern University in Chicago. Some of the reporting was quite silly.

• “New study explores healing power of Taylor Swift“
• “Rude Boy singer can get you back to rude health in no time according to new studies“
• “Listening to music and audio books is a viable alternative to medication for post-surgery pain in children“

The study authors, the chair of pediatric anesthesiology at the hospital and his daughter, a biomedical engineering student at Northwestern who is now a fourth year medical student at Johns Hopkins, make some reasonable points in the introduction. Fear of opioid-related side effects, in particular respiratory suppression, does often result in poorly managed postoperative pain in kids. And there isn’t great data on the safety and efficacy of non-opioid medications for this purpose.

What is non-pharmacological pain management?

They are also correct when they say that non-pharmacological approaches are an important aspect of treating pediatric pain. What are non-pharmacological therapies? Simply put, they are methods of managing pain that don’t involve a drug, rather they are an attempt to change how a patient thinks about or focuses on their pain.

Much of non-pharmacological pain management actually involves distraction and the reduction of the stress associated with pain or potentially painful procedures. This is where, at least in the ED and hospital setting, that Child Life services can be invaluable. The simple act of explaining to a patient what is about to happen in a developmentally appropriate way, for example, can work wonders in relieving anxiety that might exacerbate the perception of pain.

Anything that reduces the patient’s expectation of or distracts from their pain can help them to perceive it as less intense. Pain, as they say, is largely in the brain after all. This is why non-pharmacological methods such as biofeedback, massage, meditation, and cognitive behavioral therapy can lower subjective ratings of pain and even improve functionality. They aren’t magic, and they can’t take the place of appropriate medications for moderate to severe acute pain caused by tissue injury, but for other types of pain, particularly chronic pain, they can make a difference and in some cases reduce the amount of medications needed to achieve adequate control.

In the pediatric population, non-pharmacological approaches to pain do not need to be fancy, they just need to be a positive experience. Bubbles, toys that produce interesting (at least to a toddler) lights and sounds, and play are frequently employed to great effect. Music too. The authors of this study didn’t just pull that out of thin air. Music therapy is a well-established component of what we do. Some facilities have dedicated staff for it, while many just have Child Life and a guitar.

Which non-pharmacological method works best depends on the type of pain and the type of kid. Not every child responds to the same intervention. Some patients don’t respond at all. Pediatric nurses and Child Life specialists are usually adept at working these things out and for that I am extremely grateful.

As readers of Science-Based Medicine know all too well, the nonspecific benefit from placebo effects, which would include some of what I’ve just discussed, are commonly used as a foot in the door for abject nonsense. Acupuncture is the most well-recognized and accepted by people who should know better. But many hospitals and pediatric offices have also turned to forms quackery like homeopathy and reiki, among many others, in order to maximize non-pharmacological benefits at the expense of ethical patient care.

The authors of the study are again correct in pointing out that much of the data on non-pharmacological therapies has looked at its use for procedural pain. For example, blowing bubbles and singing a song with a toddler who is having blood drawn. The pain is generally mild to moderate and typically of short duration. Think getting an intramuscular shot of antibiotics for strep throat, or a few stitches in the ED. There hasn’t been much investigation into the use of these techniques after major surgeries, however. I know that they are often used in such circumstances, they just haven’t been studied all that much.

About the Study

The “prospective, randomized and controlled study,” which ran from July to December of 2010, was approved by the hospital Institutional Review Board and funded by a Northwestern undergraduate research grant. Their focus was on the potential for music and audiobooks to reduce pain in children during the first two days after a major surgical procedure. The control that they chose was silence. Not simply the absence of the music or audio book, but silence using noise-cancelling headphones. The results will not surprise you, I promise.

They recruited children from between the ages of 6 and 18 years who were undergoing orthopedic, neurosurgical, urological, plastic, or general surgeries, excluding any hearing or cognitively impaired patients. Children with a history of long term opioid use or chronic pain were also left out. Subjects were randomized into one of three groups: music, audio book, or silence. Kids in the music and audiobook groups were allowed to choose from a list of songs or books prior to their procedure.

Using the Faces Pain Scale-Revised (FPS-R), which consists of 6 facial patterns representing pain severity in increments of two from zero to ten, pain was evaluated prior to the subject listening to their chosen song or book, or enduring the silent treatment, and again after thirty minutes of the intervention. This was done twice during the first 48 postoperative hours by the chair of pediatric anesthesiology in that hospital. They looked at the difference between pain scores before and after the intervention as the primary outcome. Patients in all three groups received standard pain management, including patient controlled opioid analgesia, IV bolus opioid dosing, epidural, and non-opioid medications as clinically indicated.

What did they discover and what does it all mean?

After a lengthy discussion of their statistical gymnastics (p-hacking?), what did their audio intervention amount to? I’ll allow the study authors the honors:

The most important finding of the current investigation was the reduction in post-surgical pain in children exposed to music or audiobooks compared to control after major surgery. The reduction in pain burden was one point (0–10 scale) over 1 h of total treatment that the audio therapy groups received compared to control. Our results suggest that audio therapy should be available to minimize post-surgical pain in children undergoing major surgeries.

A 1 point decrease in the subjective reporting of pain on a scale of 0-10 is clinically fairly meaningless. Can a child, or anyone for that matter, truly differentiate between a 10 and a 9 or a 2 from a 1. Of course not. That isn’t how measurement tools like the FPS-R are used in the real world. They are just one piece of the puzzle when we evaluate pain, and often not one that does much to move help solve it. A better approach would have been to look at more objective outcomes such as a decrease in opioid dosing required to achieve pain control, or time to achieve appropriate activity goals. And to make a causal claim based on such a small number of subjects just seems absurd.

Were you surprised by any of this? It hardly seems worthy of media coverage that an unblinded psychologically positive intervention reduced pain better than essentially torturing a child with sensory deprivation. No wonder the press had to render the study conclusions virtually unrecognizable (“alternative to medication for post-surgery pain”) and focus on the meaningless fact that among the available songs were tracks by Rihanna and Taylor Swift. Why didn’t any of the news reports claim that listening to James and the Giant Peach is the key to improved recovery after major surgery?

Although in the study conclusions as well as media reports, the “patient-preferred” aspect of this study was discussed as if it mattered, I’m not sure how they were able to make that conclusion. Both treatment groups were able to have some choice in what they listened to, but that was compared to silence rather than to a selection that the patient did not prefer. For all we know, rather than the music and audiobook helping to reduce pain perception, kids forced to sit in silence for half an hour just were more sensitive to pain. Maybe the utter silence increased anxiety and reduced the effectiveness of the pharmacological management of their pain.

The study authors call for audio therapy to be included in postoperative pain management guidelines. They claim it is effective, harmless, and cheap:

In contrast to opioid analgesics, the lack of side effects of audio therapy seems to pave a promising pathway for the implementation of this intervention for children undergoing major surgeries…Improvement in analgesic control after surgery has been associated with improvements in important economic outcomes in the adult population such as reduction of hospital length of stay or unanticipated hospital readmission after surgery.

But it is ridiculous to make such a comparison. Of course listening to music has fewer side effects than morphine and dilaudid. It also has a fraction of the analgesic potential in moderate to severe acute pain caused by tissue injury, such as during an invasive surgery or the reason for having surgery in the first place. And the improved analgesic control that they refer to has been shown to improve outcomes through implementing a systematic approach to pain management largely focused on appropriate use of opioid and non-opioid medications and physical therapy. Kanye and Harry Potter are unlikely to get kids home faster or keep them from bouncing back after a major surgery.

Conclusion

This study comes across like a vanity project set up by someone in a position of influence for his child. We already know that non-pharmacological interventions can help reduce the perception of pain in kids, and even have an entire profession that is trained to provide it in the hospital setting. And we’ve been providing it for postoperative pain well before this study. We don’t care whether a child is in pain from a brief procedure or a major surgical intervention. A child in pain is a child in pain.

The study is also severely limited in its ability to make causal claims. It is small, there was zero blinding, and the chair of pediatric anesthesiology did the data collection. This could have altered interactions between nursing and the subject. Parents, who play a huge role in how a child experiences pain, may also have been effected by the lack of blinding. That being said, the result of the study is entirely plausible. It is the conclusions of the authors and the media response that are off base.

Music and books are a wonderful distraction for some kids who are stressed or in pain. It is easy to offer as a non-pharmacological intervention in the clinic, ED, or hospital, and it is cheap. But don’t expect it to take the place of appropriately dosed opioids in kids who are recovering from major surgery. That would be cruel.

from Science-Based Medicine http://ift.tt/1VN6bF9