Three years of research culminating in best practice recommendations for pediatric research

January 23, 2023  //  FOUND IN: News

Karen Cooper, M.D., started her residency in otolaryngology-head and neck surgery (also known as Ear, Nose and Throat or ENT) 25 years ago, and one of the first surgeries she learned to perform was a tonsillectomy. When she began her career, the common practice was to prescribe large amounts of an opioid to manage the significant postoperative pain patients experienced. 

Over time, Cooper noticed the lack of data available for opioid prescribing and managing pain safely for children after surgery, and she was concerned about the risks that came with prescribing postoperative opioids. She saw many patients dealing with side effects such as nausea, constipation and itching, while others called in for refills after the point pain should have resolved. In an attempt to decrease patients’ post-operative pain and opioid use, Cooper changed her surgical technique and added other non-opioid medications, but she wasn’t seeing the broader change in postoperative pain management she hoped for.

Six years ago, Cooper began working at Michigan Medicine, still individually advocating for better practices to manage pain and evidence-based opioid prescribing. Here, she met Michael Englesbe, M.D., a co-director of OPEN, who introduced her to the organization and the work they do. She learned about OPEN’s adult prescribing recommendations, and knowing that there hadn’t been any big strides in the pediatrics space, wanted to create a set of pediatric prescribing guidelines. 

“When you’re prescribing to an adult, you have a direct relationship with the provider. With kids, you have their families involved as well trying to discern how much pain they’ll go through,” Cooper said.

She knew there was a way to minimize the use of opioids after pediatric surgeries while managing pain appropriately and wanted to share this information with as many people as possible. After being awarded a Michigan Health Endowment Fund grant, Cooper partnered with OPEN to create a new set of prescribing guidelines and a bank of resources to help pediatric patients, as well as their families and providers, manage postoperative pain. 

“The goal is to custom fit prescribing to consumption, so we are still meeting the mark for pain management using opioids when they are appropriate, as well as encouraging non-opioid medications like Tylenol™ (acetaminophen) and Motrin™ (ibuprofen), and non-medication tools like meditation,” said Heidi Aslesen, grant program manager at OPEN. “Kids were getting prescribed too high of doses and physicians could see the resulting complications. This made her [Cooper] passionate about doing research to understand what was happening and communicating those findings to parents and providers.

Before the OPEN team could start sharing best practice resources, there was research to be completed and data to collect. A major project that OPEN team members undertook was completing phone surveys with parents and caregivers of pediatric patients. Through these surveys, the team collected data on how many doses of opioids patients consumed after surgery, as well as what methods families were using to treat their children’s pain and how well their pain management was overall. 

Holli Sharples and Sofea Stanton, research assistants at OPEN, were tasked with collecting patient reported outcome (PROs) surveys and inputting data throughout the process. Something that stood out right away was the mix of caregivers who did and didn’t know the risks involved in opioid prescribing. 

“Some parents knew right away they didn’t want their children prescribed opioids, and other parents didn’t exactly know the risks or what their children were being prescribed,” said Stanton. “That just shows the importance of what we’re doing and the need for strong prescription guidelines.”

A common theme found while conducting surveys was that a majority of caregivers were excited to take part and share their experiences. 

“For some of the parents, they mentioned that they were happy to give this feedback because they felt like they were contributing to the cause, they felt like they were doing more to help their children,l” recounted Sharples. 

One call that stood out to Sharples was a conversation with a police officer who acknowledged how important this work was for fighting the opioid epidemic: “He thought that strengthening the prescribing recommendations was super important and he wanted to contribute to that.”

By the end of patient data collection, more than 1,200 surveys were completed. Both Stanton and Sharples expressed their gratitude to work on this project and to contribute to something bigger than both of them, as well as recognizing this as a learning opportunity not just in research, but in understanding the importance of this work. 

Sharples concluded, “When opioids were first used, people didn’t know the potential risks. Now with the technology we have, we can look back and see where we can move forward and how we can provide better care management to our communities. We can see where the problems were, and we can work toward fixing them. We can’t stop now.” 

Cooper and the OPEN team now aimed to share everything learned. 

The team developed a Pediatric Surgical Pain Management Toolkit that was created to support surgeons and families across the state. This toolkit is a culmination of best practices and is split into two sections, one for families and one for providers; it focuses on preparing for the entire experience of surgery. 

This toolkit equips stakeholders involved in surgery and pain management. It starts at the beginning of the surgical experience, helping providers explain what the surgery is and who the patient will be in contact with during the process. It also details the best practices and recommendations for postoperative pain management. These recommendations include opioid prescribing recommendations, non-opioid recommendations, as well as non-medication practices like mindfulness and distractions. 

“We want to help prepare patients for postoperative pain and help their families and providers manage that pain,” Zahra Dawson described.

This toolkit was created to be a resource that puts all the information in one spot and details what type of pain someone may go through so that all parties involved can best prepare. 

Dawson added “We want these recommendations to be a source of lower prescribing amounts in general.” 

Now that the Michigan Health Endowment Fund grant period is coming to a close, all participating team members can agree on two things: they are proud of the work they have completed so far, and the work doesn’t stop here. 

“The opioid epidemic has been going on for too long,” Stanton said. “I think it’s important that people educate themselves about the risks, I hope people take that initiative and see that this work is important.”

Cooper said that completing this stage is “…incredibly exciting. We’ve collected data on lots of pediatric surgeries and learned that pain is managed very well, even with minimal opioid use. It’s super exciting to know that we can decrease some of the risk by cutting down on prescribing and providing further information to families. The work is never truly done, it is always ongoing and can be communicated better.” 

Dawson shared the sentiment, stating “To see how much lower the newest prescribing recommendations are compared to the previous set is extremely impactful.”

With this initial phase of work complete and the pediatric prescribing guidelines close to being published, Aslesen hopes that these recommendations push people to challenge the status quo when it comes to opioid prescribing. “Challenge the notion that opioids are the best way forward for pain management. Don’t be afraid to try other methods; there are many ways to manage pain that don’t rely on opioids.”

Next steps in this research include integrating youth voices into the work. Cooper shared, “We will continue to collect data, and we plan to expand our efforts to work with adolescents. They have their own voice in their care, and we want to know what will be helpful for them.”

While the pediatric prescribing guidelines go through final revisions, Aslesen hopes the impact of this research causes change across Michigan. 

“I hope this grant starts the conversation. We have some great findings that can initiate conversations and start some change. I think that is the most powerful piece of this work, getting to start the conversation. We have so much opportunity here and we plan to use the momentum we have to make a difference.”

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