Opioid stewardship program implementation in pediatric surgeries: A systematic review

Abstract

Background:

Postoperative opioid use in pediatric surgeries presents significant challenges due to associated risks such as dependence, oversedation, and misuse. Opioid stewardship programs (OSPs) aim to mitigate these risks by promoting appropriate opioid prescribing and multimodal pain strategies.

Objectives:

To evaluate the effectiveness of current OSPs and their impact on opioid prescribing practices in pediatric surgeries.

Methods:

We systematically searched PubMed, MEDLINE, Embase, Cochrane Library, CINAHL, and Web of Science for English language studies (2011–2024) that described opioid stewardship initiatives in pediatric surgery. Eighteen studies were included. We included randomized controlled trials, observational studies, and systematic reviews, excluding studies without a formal OSP, studies exclusively focusing on adults, and those without any specific outcomes. Data extraction and quality assessment were performed independently by multiple reviewers. Risk of bias was evaluated using Cochrane and ROBINS-I tools.

Results:

Eighteen studies were included with sample sizes ranging from 81 to more than 83,000 patients. The key interventions included opioid prescribing protocols, and guidelines, provider education about opioid use, and alternative pain management options to limit opioid dependence. All the studies reported reduction in opioid prescribing rates. There was reduction in discharge prescriptions from 68.4% to 10.7% after introducing consent (P < 0.001). There were no significant increases in emergency department visits related to reduced opioid prescribing. Pain scores remained stable, and oversedation events were reduced in some settings.

Conclusion:

Structured opioid stewardship interventions including protocols and guidelines, combined with targeted education and improved pain management techniques, effectively reduce opioid use while preserving adequate pain control. Future multicenter trials and studies will be required to further optimize opioid stewardship interventions and maximize patient outcomes.

Introduction

Opioid stewardship programs (OSPs) are increasingly recognized as a vital component in pediatric perioperative care. Opioids are essential for managing moderate to severe postoperative pain, but there are hazards associated with opioid prescriptions, including nausea, vomiting, constipation, oversedation, prolonged use, dependence, accidental overdose, and increased risk of diversion of unused medications.[1,2,3]

In pediatric surgical practice, opioids should only be prescribed when nonopioid multimodal analgesia fails to adequately control pain. Criteria for ‘absolute necessity’ include moderate-to-severe pain scores, surgeries associated with high nociceptive input (e.g., thoracic, orthopedic, or major abdominal procedures), and documented contraindications to nonopioid alternatives.[1,3] Multiple studies, particularly from North America, have demonstrated a correlation between increased pediatric opioid prescribing and higher rates of prolonged use, dependence, and nonmedical misuse among adolescents following surgery.[2,4] While most data originate from the United States, similar concerns have been reported in Canada and parts of Europe, indicating a potential global issue influenced by local prescribing cultures and institutional protocols.[1,3]

This trend is concerning. Recent research indicates that a sizable percentage of pediatric patients receive opioids after surgery, frequently at dosages higher than advised, which raises questions regarding the possibility of long-term reliance and adverse side effects.[4,5]

The incidence of opiate prescriptions in pediatric procedures is brought out by concerning figures. For instance, one study revealed that 36% of pediatric surgery patients were prescribed opioids at the time of discharge, and many received doses exceeding recommended age- and weight-based guidelines, or quantities greater than necessary for expected postoperative pain duration. Such variability is partly influenced by the type of surgery performed, with higher prescription rates observed in orthopedic, thoracic, and major abdominal procedures compared to minor ambulatory surgeries.[1,5]

The lack of established protocols for prescription opioids in pediatric settings worsens this issue and leads to variations in procedures among surgical specialties and institutions. There is a substantial knowledge and practice gap as evidenced by the inconsistent adherence to recommendations to reduce opioid prescriptions made by the Food and Drug Administration and the Centers for Disease Control and Prevention.[4]

These knowledge gaps in the efficacy of current OSPs and the results linked to different prescribing strategies in pediatric surgeries make this study necessary. This systematic review aims to assess how OSPs affect prescribing practices, patient safety, and pain outcomes in pediatric surgical patients; it also seeks to identify best practices and pinpoint areas that need further research.

Methods

This systematic review was conducted using a structured ten-step methodology (2023),[6] which details a structured approach comprising ten essential steps. The review protocol was registered in the PROS-PERO International Prospective Register of Systematic Reviews (CRD42024578781).

Search strategy and study selection

We searched PubMed (MEDLINE), Embase, and Web of Science using these keywords: (“opioid stewardship” OR “opioid management” OR “opioid safety” OR “opioid prescribing”) AND (“pediatric surgery” OR “pediatric surgical” OR “children” OR “adolescents”) AND (“implementation” OR “program” OR “intervention” OR “initiative” OR “strategy” OR “approach”) AND (“opioid consumption” OR “opioid prescribing” OR “opioid-related adverse events” OR “opioid-induced complications” OR “opioid-sparing”) AND (“barriers” OR “facilitators” OR “sustainability” OR “optimisation” OR “quality improvement”).

Using Rayyan, a collaborative screening tool,[7] four reviewers screened the titles and abstracts of 139 identified articles. Among these, 37 articles were selected for full assessment, which was done by another four reviewers. Ultimately, only 18 studies met the inclusion criteria and were included in the review.

Inclusion criteria

We conducted a systematic review from 2014 to 2024 of relevant English-language articles. Randomized controlled trials, observational studies, case-control studies, cohort studies, systematic reviews, and meta-analyses were included. When it came to comparison, studies comparing outcomes before and after the implementation of OSPs and studies comparing outcomes between pediatric surgical settings with and without OSPs were also included.

The following postoperative outcomes, including opioid prescribing practices (e.g., prescription rates, dosages, and durations), opioid consumption by patients, opioid-related adverse outcomes (e.g., respiratory depression, opioid-induced nausea or vomiting, constipation), and length of hospital stay, were all included.

Exclusion criteria

Studies without a formal OSP or initiative were excluded. Studies exclusively focusing on adult surgical patients are excluded too. Studies without any specific outcomes were also excluded.

Quality assessment

Methodological quality was assessed by three reviewers using Cochrane’s tool for assessing risk of bias in randomized controlled trials and ROBINS-I for nonrandomized comparative studies. The risk of bias for studies included was classified as low, moderate, or high, and an overall assessment for each was provided. Kelley-Quon et al., for example, had low risks across most domains; Ahn et al. and Vermaire et al. showed the same, whereas Keane et al. and Donado et al. had moderate to high risks, especially in confounding and reporting. Most of the studies shared the issues of moderate risks in confounding and deviations from intended interventions, as with the studies of Megan Stout and Sara A. Mansfield. The review shows overall large variation in study quality and points to several studies with solid methodological approaches, while some have potential biases that require cautious interpretation.

Results

Figure 1 shows that 134 studies were initially identified from the database searches. After removing five duplicates, title and abstract screening ensued, and 37 studies were eligible for full-text screening. Of these, 19 studies were excluded, and 18 studies met the inclusion criteria.

Figure 1.

PRISMA flow chart for the study

Study characteristics

The 18 studies[8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25] investigated in the present review were published between 2011 and 2024, which examined various opioid stewardship interventions within pediatric surgical populations [Table 1]. The studies covered a range of surgical specialties such as general surgery, urology, orthopedics, and otolaryngology. Sample sizes across these studies varied significantly, ranging from 81 to over 83,000 patients. Most of the studies were single-center quality improvement initiatives or retrospective cohort studies, although a few were conducted across multiple centers.

Table 1.

Summary of the included studies

Interventions

The opioid stewardship interventions included standardized opioid prescribing protocols, multimodal nonopioid analgesia pathways, provider education sessions, electronic prescription monitoring tools, and mandatory opioid consent forms for caregivers.[2,5]

Several studies introduced protocols and guidelines for prescribing to ensure consistency and accuracy in opioid prescriptions.[2,5,8,9,11,14,17,19,21] Another common intervention involved educating healthcare providers on the use of opioids. The main goal of this approach was to enhance the understanding and skills of healthcare professionals regarding drug usage practices.[5,8,11] Educational interventions targeted various groups of healthcare providers including surgeons, anesthesiologists, pediatricians, nurses, and pharmacists. Techniques included structured in-person workshops, online training modules, distribution of standardized prescribing guidelines, and reminders integrated into electronic health record (EHR) systems. In several studies, education was delivered multiple times over several months or incorporated into annual continuing medical education sessions to ensure sustainability and long-term adherence to opioid stewardship principles.[2,5]

Some studies also utilized recovery strategies centered around ways to manage pain, aiming to reduce reliance on opioids by incorporating different pain management techniques.[8,19] Several studies reported modifications to EHR systems to optimize opioid prescribing. These included mandatory documentation of indication for opioid prescriptions, automated alerts when exceeding recommended dosages, default prescription quantities aligned with evidence-based guidelines, and integrated multimodal analgesia order sets. Such interventions were primarily feasible in centers with electronic prescribing capabilities; however, in hospitals using paper-based systems, similar effects were achieved through standardized preprinted prescription templates and mandatory sign-off protocols by attending physicians.[2,5]

Outcomes

The primary outcome across most studies was a reduction in opioid prescribing, and all studies that measured this outcome reported significant decreases. Most studies compared pre- and postintervention prescribing rates and reported statistical significance based on Chi-square or Fisher’s exact tests with P < 0.05. Others defined significance as a relative reduction exceeding 20%–50% in the number of opioid prescriptions per 100 discharges compared to baseline. This heterogeneity in definitions reflects differences in study design, sample size, and institutional benchmarks.[2,5] For instance, a study by Amin et al., 2024 illustrated a 43.44% decrease in the number of opioid doses post-tonsillectomy. Additionally, another study by Sutyak et al., 2024 demonstrated that only a small proportion of patients (9%) were given prescriptions at the time of discharge after introducing a stewardship program. Moreover, Stout et al. documented a marked reduction of 50% or more in prescriptions for conducted outpatient urological procedures (Stout et al., 2023). One study showed a significant decrease in both the amount of opioids prescribed (significant at P < 0.0001) and prescriptions filled (at P = 0.009).[2] Keane et al. reported a complete elimination of opioid prescribing at discharge for pediatric complicated appendicitis.[21] Pace and colleagues found that opioid prescription rates were 6.5 times lower after the introduction of stewardship interventions.[22] Similarly, Villanueva et al. noted a reduction in the number of prescriptions given at discharge, from 68.4% to 10.7%, after introducing consent (significant, at P < 0.001).[23]

Several studies also evaluated the impact of reduced opioid prescribing on pain management and discovered that there were no variations in how patients rated their pain levels between individuals who were prescribed opioids and those who were not.[2,5,22] Another study revealed that 59% of patients reported a pain score of zero within 3 days of discharge with only 4% reporting scores ranging between 6 and 8.[10] Ahn et al. noted that there was no increase in pain scores despite the reduction in opioid use.[19] Pain assessment methods varied across included studies. Most investigations focused on common pediatric procedures such as tonsillectomy, appendectomy, orthopedic, and minor abdominal surgeries. Pain scores were evaluated using validated pediatric tools, including the Wong-Baker FACES scale, FLACC observational scale for nonverbal children, and Visual Analog Scale for older children and adolescents. Assessments were typically performed by nursing staff or caregivers at standardized intervals during hospitalization and via follow-up calls after discharge. Across these studies, no clinically significant differences in reported pain scores were observed between patients receiving opioids and those managed with multimodal nonopioid analgesia.[2,5]

Numerous research studies have explored the impact of reducing prescriptions on healthcare usage patterns and reported no significant increases in emergency department visits, readmissions, or unplanned visits related to pain management.[2,5,10,21,23] Also, a study by Keane et al. noted a significant decrease in readmissions within 30 days after enforcing guidelines on opioid prescriptions.[21] A few studies particularly tracked negative outcomes associated with the use of opioids. Following a multimodal intervention, the study documented a reduction in opioid-related oversedation occurrences, from 0.15 to 0.074 per 1000 patient days.[20]

Quality of evidence

The general evidential quality was moderate. Most of the studies were observational, introducing intrinsic constraints such as possible confounding variables and the absence of randomization. Despite these constraints, the uniformity of results across several studies and environments adds to a strong body of evidence that supports the efficacy of opioid stewardship measures in pediatric surgical settings.

Discussion

Our findings align with recent evidence highlighting that structured OSPs effectively reduce unnecessary opioid prescribing in pediatric surgeries without compromising pain outcomes.[2,5] This review builds on existing literature by demonstrating that multimodal analgesia, provider education, and electronic monitoring consistently contribute to improved prescribing practices across diverse surgical populations. These results emphasize the importance of institutional protocols and suggest that broader adoption of stewardship interventions could standardize postoperative pain management globally.

OSPs have emerged as useful strategies to address the opioid crisis, especially in vulnerable populations such as pediatric surgery patients. Our review of 18 studies showed that these programs significantly reduce opioid prescriptions without compromising pain management or increasing healthcare visits, aligning with earlier studies that emphasize the importance of opioid protocols in pediatric care.[1,24] Our review indicates a consistent reduction in opioid prescriptions across different surgical settings, which aligns with previous research showing similar trends. For example, Amin et al. (2024) and Sutyak et al. (2024) reported declines in opioid use postsurgery, mirroring the findings of Jones et al., who noted reduced opioid prescribing following guideline implementation in pediatric orthopedic procedures.[25] This similarity shows the effectiveness of OSPs in standardizing opioid prescribing practices.[26] Education-based interventions in the reviewed studies, such as those by Creamer et al. (2021) and Stout et al. (2023), play an important role in reducing opioid prescriptions. Prior studies also found that educational initiatives increased healthcare providers’ adherence to guidelines, enhancing their understanding of opioid risks.[27,28]

These findings suggest that training for prescribers is important for sustaining reductions in opioid use across different healthcare settings. Our study findings also showed the effectiveness of EHR modifications as part of OSPs, a strategy reflected in Vermaire et al. (2011) and Stephenson et al. (2024). Prior published studies similarly demonstrated that EHR modifications facilitate monitoring and regulation, allowing providers to limit excessive opioid prescriptions effectively.[29,30] Thus, integrating OSPs with technology is a vital strategy for minimizing prescription variability.

The observed reductions in opioid-related adverse effects, such as oversedation, align with findings from multicenter studies showing lower sedation rates when multimodal pain management is employed. Several high-quality studies have demonstrated the effectiveness of multimodal pain management strategies—combining scheduled acetaminophen, NSAIDs, local or regional anesthesia techniques, and nonpharmacologic interventions—to provide adequate postoperative analgesia in children while minimizing opioid exposure. In the included studies, intervention groups receiving multimodal analgesia were compared to standard care groups that primarily relied on opioid prescriptions, showing equal or superior pain control with significantly fewer opioid doses (Kelley-Quon et al., 2021; Amin et al., 2024; Waldfogel et al., 2024).

Vermaire et al. (2011) recorded fewer instances of oversedation, echoing a study from Viteri Hinojosa and Andrés Sebastián that associated multimodal interventions with safer pain management outcomes.[31] This suggests that OSPs not only reduce opioid usage but also enhance patient safety in pediatric surgery.[32] Another important finding from our review is the lack of increased pain scores despite reduced opioid use, as seen in studies by Calderon et al. (2021) and Ahn et al. (2024). Recent pediatric studies support this observation, showing that multimodal pain management strategies—including scheduled acetaminophen, NSAIDs, and regional anesthesia—can effectively control postoperative pain while reducing opioid exposure in children.[1,3,5]

These consistent results strengthen the argument for nonopioid pain relief as a reliable approach for postoperative pain in pediatric patients. Our review also found that reducing opioid prescriptions does not lead to higher rates of unplanned healthcare visits, a concern often cited in opioid reduction strategies. Calderon et al. (2021) and Pace et al. (2023) reported no rise in emergency department (ED) visits or readmissions, findings that align with Meisenberg et al. and Carroll et al., who observed no increase in ED visits following decreased opioid prescribing.[33,34] These findings reassure providers that reducing opioids does not compromise follow-up outcomes in pediatric patients. State-mandated consent forms, such as those examined by Villanueva et al. (2021), showed promising results in decreasing opioid prescriptions. Studies by Avoundjian et al. and Mammucari et al. similarly noted that informed consent increases awareness among patients and families, contributing to more cautious opioid use.[35,36] Mandatory consent forms were typically signed by parents or legal guardians prior to the dispensing of opioid prescriptions. These forms outlined the specific opioid prescribed, potential side effects (including oversedation, nausea, constipation, and risk of dependence), recommended safe storage and disposal practices, and available nonopioid alternatives. The process aimed to ensure caregivers were fully informed about opioid risks and engaged in shared decision-making regarding postoperative pain management.[5,21]

The observed reductions in opioid-related adverse effects, such as oversedation, align with findings from multicenter studies showing lower sedation rates when multimodal pain management is employed. A few included studies were adequately powered to detect statistically significant differences in opioid-related adverse events, such as oversedation, nausea, or unplanned readmissions. Most studies were single-center quality improvement projects or retrospective analyses with relatively small sample sizes, primarily designed to evaluate prescribing behavior rather than clinical safety outcomes. As a result, conclusions regarding reductions in negative outcomes should be interpreted with caution, highlighting the need for larger, multicenter trials to assess safety endpoints robustly.[2,5]

This indicates that mandatory consent could be a useful addition to OSPs, enhancing patient education on the risks associated with opioids. This review has several limitations. Most studies included were observational and single-center, which can introduce biases and limit generalizability. Reliance on retrospective data also means that some factors, like individual patient preferences or provider practices, cannot be fully captured. While many studies measured reductions in opioid prescriptions, a few explored long-term outcomes like patient satisfaction or quality of life postsurgery. Another thing we would like to highlight is the viability and acceptability of using randomized controlled trials (RCTs) to assess the efficacy of OSPs. We think that both opportunities and limitations exist regarding this matter. In our opinion, even while RCTs are the most reliable method for establishing causation, it may not always be feasible to apply them to system-wide treatments like OSPs. It would be logistically difficult and morally dubious to randomly assign individual patients to receive care in facilities with or without OSPs because this could expose control group patients to possibly preventable risks associated with opioid overprescription.

In this instance, we were considering a more effective alternative with a lower risk to individuals: cluster randomized studies, in which entire hospitals or surgical centers are randomized to implement OSPs or maintain standard practices. By guaranteeing that all patients receive evidence-based pain management, this strategy would uphold ethical integrity while enabling the assessment of system-level outcomes, such as opioid prescribing rates, patient safety, and healthcare use. Such trials may be carried out in areas like North America or Europe, where there is a great degree of variation in opioid prescribing practices and where OSPs may have a more noticeable effect. However, these trials would require extensive monitoring to account for variations in baseline practices between sites and defined standards to guarantee consistency in OSP implementation. What we also want to discuss is that according to the author’s knowledge and research, there are no studies from countries other than the United States that specifically address pediatric OSPs.

We believe the following reasons may explain this. The U.S. has prioritized opioid stewardship for all demographics, including children, due to the significant public health impact of the opioid crisis, which has historically included overprescription for surgical procedures, injuries, and chronic pain in pediatric patients. Organizations such as the American Academy of Pediatrics and the Centers for Disease Control and Prevention have issued guidelines for opioid use in children, and many pediatric hospitals implement dedicated stewardship programs. The U.S. also benefits from robust research funding (e.g. NIH grants) and a strong research infrastructure, resulting in more studies. Additionally, legal frameworks such as Prescription Drug Monitoring Programs extend to pediatric care, fostering targeted research and implementation. In contrast, other countries may have fewer studies on this topic due to less severe opioid crisis, different pain management practices that rely less on opioids, limited funding for pediatric-specific research, and a primary focus on adult populations more commonly affected by opioid misuse. So, more future studies should focus on expanding search terms, exploring regional guidelines, and utilizing multinational databases to provide broader perspectives and address this gap in the literature. Also, more review studies should focus on large, multicenter randomized trials to better understand the long-term effects of OSPs in pediatric surgeries. Studies should also examine patient outcomes beyond pain control, like overall recovery experience and mental health impacts. Exploring more specific guidelines for different surgical types could help tailor OSPs to various needs. Assessing the role of family education and engagement in pain management could strengthen stewardship efforts as this can further support reduced opioid reliance in pediatric patients.

Conclusion

This systematic review has assessed the effectiveness of various opioid stewardship interventions in reducing opioid prescribing patterns in pediatric surgical populations.

The review identifies that measures such as prescribing protocols, provider education, and multimodal pain management significantly reduce opioid use while maintaining effective pain control. Importantly, the findings indicate that reduced opioid prescribing does not negatively affect patient outcomes, including pain levels or healthcare utilization. Future research should focus on randomized controlled trials to evaluate specific components of stewardship programs, such as standardized discharge protocols or multimodal pain strategies. Such studies can provide deeper insights into optimizing these interventions to enhance patient safety and care quality in pediatric surgical settings.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.