CHICAGO — A 21-element recovery program for children undergoing gastrointestinal surgery reduced opioid use during hospitalization by 56%, according to a large clinical trial led by Northwestern University and Ann & Robert H. Lurie Children's Hospital of Chicago.
Children treated with at least 13 elements from the program resumed eating sooner after surgery, stayed in the hospital one less day on average and had roughly half the risk of complications compared to children who received fewer elements.
The study will publish May 13 in JAMA Surgery.
The authors say the findings come from one of the largest pediatric surgery clinical trials ever conducted in the U.S. The trial enrolled nearly 600 children and teens undergoing elective gastrointestinal (GI) surgery across 18 pediatric centers nationwide.
The 21 steps — called an enhanced recovery protocol — are best practices to help patients recover faster. Some steps start before surgery, such as letting patients drink clear liquids like apple juice on the morning of surgery. Others happen during surgery, such as using minimally invasive surgery when possible.
After surgery, steps include encouraging patients to eat and walk as soon as possible, minimizing tubes and drains, and using pain treatments that limit reliance on opioids. (See the 21 steps here.) The protocols also encourage the clinical team to educate families about the procedure and recovery process.
"Several of the most important components of the protocols are driven by patients and families," said study lead author Dr. Mehul Raval , a professor of pediatric general surgery at Northwestern University Feinberg School of Medicine and pediatric surgeon at Lurie Children's.
"By using these steps, we can get kids better faster and decrease the chances of complications. This helps get them back to school and living their best lives," he added.
The protocols have been widely used in adult surgery for years. But adoption in pediatric surgery has lagged, and most previous pediatric studies were small and limited to single hospitals.
How the study was conducted
The ENRICH-US trial enrolled 597 patients ages 10 to 18 undergoing elective GI surgery between 2019 and 2024. Most patients underwent surgery related to inflammatory bowel disease. The scientists chose GI surgery because the protocols have been especially successful in adult colorectal surgery, a subset of GI surgery.
In the study, every hospital moved through three phases over time. During the first phase, hospitals provided their usual surgical care. During the implementation phase, hospitals began rolling out the 21 steps with training and support from the study team. In the third phase, hospitals continued using the protocols after the training period ended. Raval and his team tracked how many of the 21 steps each patient received and compared outcomes across the three phases.
The scientists found that, on average, hospitals improved delivery of the protocols from 11 elements in phase one to 14 elements in phase three.
Cutting opioid use
In the third phase of the study, average opioid use per day dropped by 56%, compared to the first phase before the program had been implemented. Reducing opioid exposure is especially important for children and teens because of addiction risks. There are also short-term issues with opioids, such as constipation and sleepiness, that can negatively impact recovery.
"We have realized that opioid stewardship is a very important aspect of pain control after surgery," said Raval, who added that there are many approaches to manage pain.
"One example is the use of local nerve blocks to help numb the areas where surgical incisions are located. After hearing from patients that many concerns involved anxiety and stress, not just pain, we also developed deep breathing videos and incorporated mindfulness into our surgical experiences." Raval said.
Next steps
Raval and colleagues found that the hospitals with the strongest culture and commitment to the recovery protocols, as well as integration of the 21 steps in the electronic health records, had most success with implementing the protocols.
Applying those lessons, Raval says his pediatric surgical team at Lurie Children's is expanding the use of the protocols beyond GI surgery and applying many of the steps for younger children undergoing surgery, including newborns.J
The study is titled "Implementation and Effectiveness of an Enhanced Recovery Protocol for Children Undergoing Surgery: The ENRICH-US Stepped-Wedge Cluster-Randomized Trial." It was funded by the National Institutes of Health (grant No. R01HD099344).
