Liposomal Bupivacaine Suspension Can Reduce the Length of Stay of Patients Undergoing Open Reduction and Internal Fixation of Mandibular Fracture.

BACKGROUND: Poorly controlled postoperative pain results in prolonged length of stay (LOS). The use of liposome bupivacaine injectable suspension (LB) for postoperative pain control is a relatively recent practice. PURPOSE: The purpose of this study was to investigate the following. In patients undergoing open reduction and internal fixation of mandibular fracture(s), does the use of LB reduce LOS compared with regular bupivacaine? STUDY DESIGN, SETTING, SAMPLE: We implemented a retrospective cohort study of consecutive patients with mandibular fracture(s) presented to Grady Memorial Hospital in Atlanta, GA, from January 2021 to January 2022. Adult patients diagnosed with 1 or more isolated mandibular fracture(s) and treated by open reduction and internal fixation were included. We excluded patients with non-isolated mandibular fracture(s), isolated condyle, infected, previously treated fractures, and documented allergy to amide local anesthetics and/or its preservatives. PREDICTOR/EXPOSURE/INDEPENDENT VARIABLE: Primary predictor variable was local anesthetic (regular bupivacaine alone or LB/regular bupivacaine). MAIN OUTCOME VARIABLE(S): Primary outcome variable was LOS, defined as the number of days from surgical procedure until discharge. Secondary outcome variables were number of opioid prescription refill(s) and postoperative pain at discharge, determined with visual analogue scale. COVARIATES: The covariates were Demographics, American Society of Anesthesiologists classification, smoking, alcohol exposure, illicit drug use, etiology, location, laterality, number of fracture(s), surgical approach, and method of maxillomandibular fixation. ANALYSES: Univariate and bivariate analyses were calculated. Statistical significance was P < .05. RESULTS: Sixty-two subjects met the inclusion criteria (31 subjects in each group). The mean ages in LB/regular bupivacaine and regular bupivacaine alone groups were 33.3 (±12) and 35.1 (±15.6), respectively (P = .94), the mean LOS in days was 0.23 (±0.44) in LB/regular bupivacaine and 1.48 (±1.77) in regular bupivacaine alone (P= < .001), and the mean VAS pain scores for LB/regular bupivacaine and regular bupivacaine alone groups were 0.53 (±1.07) and 1.87 (±2.66), respectively (P = .02). Mean number of opioid prescription refill(s) was 0 in LB/regular bupivacaine and 1 in regular bupivacaine alone group, respectively (P = .01). CONCLUSION AND RELEVANCE: The use of LB/regular bupivacaine for mandibular fracture(s) results in decrease in LOS and number of opioid refills compared to regular bupivacaine alone.

Does a Point-of-Care 3-Dimensional Printer Result in a Decreased Length of Surgery for Orbital Fractures?

BACKGROUND: Utilization of point-of-care 3-dimensional printing (3DP) has decreased length of surgery in facial trauma. Little is known regarding 3DP's impact on length of surgery in orbital fracture. PURPOSE: The purpose of this study was to compare length of surgery between 3DP/preadapted (3DPPA) orbital plates and intraoperative adapted plates (IOAP) for orbital fracture reconstruction. STUDY DESIGN, SETTING, SAMPLE: This was a prospective, non-blinded, randomized clinical study of consecutive subjects with orbital fractures presented to Grady Memorial Hospital in Atlanta, Georgia, between January 2018 and June 2021. Subjects ≥ 18 years, unilateral fracture, no previous orbital surgery, and/or congenital craniofacial anomaly were included. We excluded subjects <18 years and bilateral fractures. PREDICTOR/EXPOSURE/INDEPENDENT VARIABLE: Primary predictor variable was the treatment approach. Randomization software was used, and subjects were randomized to 3DPPA or IOAP groups. MAIN OUTCOME VARIABLE(S): Primary outcome variable was length of surgery in minutes. Secondary outcomes were the time required for plate insertion and fixation in minutes, operating room (OR) charges, and orbital volume (OV) calculation. COVARIATES: Age, sex, race, etiology, laterality, location, dimension, indication for surgery, postoperative enophthalmos, and diplopia. ANALYSES: Univariate and bivariate analyses were calculated. Statistical significance was P < .05. RESULTS: Twenty-five subjects met the inclusion criteria. Mean ages in 3DPPA and conventional IOAP groups were 41.5 (±9) and 38.2 (±10, P = .31), respectively. The mean length of surgery was 32.6 (±13.7) in 3DPPA and 53.3 (±12.8, P < .001) in conventional IOAP. The mean time required for plate insertion and fixation was 15.8n (±14.4) in 3DPPA and 41.4 (±9.4, P < .001) in conventional IOAP. The mean OR charges were $1,072.5 (±524.6) in 3DPPA and $1,757.3 (±422.6, P ≤ 0.001) in conventional IOAP. The mean calculated OV of uninjured and reconstructed orbit for the 3DPPA was 23.5 (±3.2)cm3 and 23 (±3.5, P = .37)cm3, respectively. The mean calculated OV of uninjured and reconstructed orbit for conventional IOAP was 28.6 (±3.6)cm3 and 22.8 (±2.6, P < .001)cm3, respectively. CONCLUSION AND RELEVANCE: Using 3DP to produce a model that enables preoperative plate bending/adaptation reduces the length of surgery, decreases OR charges, and results in predictable OV.

The Contemporary Management of Temporomandibular Joint Intra-Articular Pain and Dysfunction.

The understanding of the causes of temporomandibular joint pain and dysfunction has evolved over 50 years. Historically, the term internal derangement has been used to describe the abnormal relationship between the articular disc, condyle, and glenoid fossa, which was thought to correlate with patient symptoms. It is now known that the pathophysiology of intra-articular pain and dysfunction (IPD) involves synovitis, capsular impingement, symptomatic disc displacement, or a combination of these. Symptomatic disc displacement should only be considered to be a potential source of IPD after synovitis and capsular impingement have been treated. This philosophy provides the opportunity for most patients with IPD to be initially treated nonsurgically or with minimally invasive procedures such as arthrocentesis or arthroscopy.

Do Racial Differences in Orbital Volume Influence the Reconstruction of Orbital Trauma.

PURPOSE: Successful orbital reconstruction relies on an accurate restoration of orbital volume (OV). The purpose of this study was to determine if the OV of African American (AA) subjects differs from that of Caucasian subjects. METHODS: The authors implemented a retrospective observational study of successive subjects who received a maxillofacial computed tomography (CT) scan at a level I trauma center between 2017 and 2020. The primary predictor variable was race (AA/Caucasian). The primary outcome variable was orbital volume. Two independent examiners calculated OV with an open access OsiriX MD software version 10.0.5 (Pixmeo, Switzerland). Inter-rater reliability was calculated. Differences between races, genders, and sides were tested using independent samples t test with a significance of P < .05. RESULTS: Sixty subjects (120 orbits) were included in the study. The mean age was 36.7 (SD ± 13.2) years with a range of 22 to 78 years. Gender distribution was equal with 30 male (50%) and 30 female (50%) subjects. Inter-examiner reliability was 0.973. The mean OV of AA and Caucasians was 22.38 and 23.23 cm3, respectively (P = .07). The mean OV of AA and Caucasian males was 23.92, and 24.17cm3, respectively (P = .71). The mean OV in AA and Caucasian females was 20.84 and 22.28cm3, respectively (P = .013). CONCLUSIONS: African-American female subjects appear to have a smaller OV when compared with Caucasians which may influence orbital reconstruction. Laterality does not appear to be associated with any differences in OV.

Does the Use of Hybrid Arch Bars for the Treatment of Mandibular Fractures Reduce the Length of Surgery?

PURPOSE: The use of hybrid arch-bar systems that use bone support is a relatively recent development in the management of mandibular fractures with the potential to reduce surgical time. The purpose of this study was to compare the length of surgery between hybrid arch bars and traditional Erich arch bars in the treatment of mandibular fractures. MATERIALS AND METHODS: The author implemented a prospective, randomized, nonblinded study of consecutive patients presenting with mandibular fractures to Grady Memorial Hospital. The primary predictor variable was the use of hybrid arch bars versus Erich arch bars. The primary outcome variable was the length of surgery. Secondary outcome variables included time to place the arch bars and fracture healing. Univariate and multivariate statistics were computed with P < .05 being considered significant. RESULTS: Fifty patients were enrolled and completed the study. The mean length of surgery was 108 minutes in the hybrid group and 117 minutes in the Erich arch-bar group (P = .62). The mean time taken to place the arch bars was 14 and 37 minutes in the hybrid and Erich arch-bar groups, respectively (P < .0001). There was no difference in fracture healing between the groups (P = .58). CONCLUSIONS: Hybrid arch bars, although reducing the time needed to place the arch bars compared with traditional Erich arch bars, do not appear to result in a reduction in the length of surgery when treating isolated mandibular fractures.

Proceedings of the American Association of Oral and Maxillofacial Surgeon's 2017 Clinical and Scientific Innovations in Oral and Maxillofacial Surgery (CSIOMS).

The sixth biennial Clinical and Scientific Innovations in Oral and Maxillofacial Surgery, formerly the Research Summit, of the American Association of Oral and Maxillofacial Surgeons and its Committee on Research Planning and Technology Assessment was held in Rosemont, Illinois from April 28 to 30, 2017. The goal of the symposium is to provide a forum for the latest clinical and scientific advances to be brought to the specialty. It also nurtures collaboration and the development of relationships between oral and maxillofacial surgeons and researchers to bridge the gap between clinical and basic science. The goal is to improve the care of oral and maxillofacial surgical patients through the advancement of translational and clinical research.

Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short Term for Improving Function and Quality of Life After Arthrocentesis? Part 2.

PURPOSE: Although arthrocentesis has been used for the management of patients with temporomandibular joint pain, the benefit of hyaluronic acid (HA) or corticosteroid (CS) remains uncertain. The purpose of this study was to assess the efficacy of HA, CS, and lactated Ringer solution (LR; placebo) after arthrocentesis for changes in quality of life (QoL), jaw function (Jaw Function Limitation Scale [JFLS] score), and maximum incisal opening (MIO). MATERIALS AND METHODS: This was a prospective multicenter double-blinded randomized clinical trial. Consecutive patients presenting to the oral and maxillofacial departments at Emory University, the University of Pennsylvania, the University of California-Los Angeles, the University of Cincinnati, and the Oregon Health Sciences University were enrolled in the study. Patients were randomized to HA, CS, or LR. All patients underwent arthrocentesis and then instillation of HA, CS, or LR. All patients were evaluated clinically at 1 and 3 months. The outcome variables were QoL, JFLS score, and MIO. Univariate, bivariate, and multivariate statistics were computed, with a P value less than .05 considered significant. RESULTS: One hundred two patients were enrolled in the study. Four were lost to follow-up, leaving 98 patients for analysis of data at 1 month. An additional 51 were lost to follow-up at 3 months, leaving 51 patients for data analysis at this time point. There was no difference among groups for QoL Mental Health Composite score at 1 month (P = .70) or 3 months (P = .69). There was no difference among groups for JFLS score at 1 month (P = .71) or 3 months (P = .98). There was no difference among groups for MIO at 1 month (P = .47) or 3 months (P = .31). All groups showed within-group improvements in JFLS score and MIO at 1 and 3 months. CONCLUSION: Arthrocentesis alone is as efficacious as arthrocentesis with HA or CS in improving jaw function and MIO at 1 and 3 months. QoL is not improved with arthrocentesis alone or in combination with CS or HA.

Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short-Term Reduction of Temporomandibular Joint Pain After Arthrocentesis? Part 1.

PURPOSE: Arthrocentesis has been used for the management of patients with temporomandibular joint (TMJ) pain, with good success. The additional use of hyaluronic acid (HA) or corticosteroid (CS) remains controversial. The purpose of this study was to compare HA, CS, and lactated Ringer solution (LR; placebo) after arthrocentesis. MATERIALS AND METHODS: This was a prospective multicenter double-blinded randomized clinical trial. Consecutive patients presenting to the oral and maxillofacial departments at Emory University, the University of Pennsylvania, the University of California-Los Angeles, the University of Cincinnati, and the Oregon Health Sciences University were enrolled in the study. Patients were randomized to HA, CS, or LR. All patients underwent arthrocentesis and then the instillation of HA, CS, or LR. Patients were evaluated clinically at 1 and 3 months. The primary outcome variable was pain at 1 month (by visual analog scale). Secondary outcome variables were pain at 3 months and analgesic consumption. Univariate, bivariate, and multivariate statistics were computed, with a P value less than .05 considered significant. RESULTS: One hundred two patients were enrolled in the study. Four were lost to follow-up, leaving 98 patients for the final analysis. The mean age of patients in the HA, CS, and LR groups was 39.6, 44.3, and 51.8 years, respectively (P = .02). There was no difference among groups in time to follow-up at 1 month (P = .11). The mean decrease in pain in the CS group was 19% for right-side procedures (P = .12) and 36% for left-side procedures (P = .02). The mean decrease in pain in the HA group was 31% for right-side procedures (P = .01) and 34% for left-side procedures (P = .01). The mean decrease in pain in the LR group was 43% for right-side procedures (P < .01) and 37% for left-side procedures (P < .01). There was no difference in pain decrease among groups (P = .55). There was no difference in the use of narcotic (P = .52) or nonsteroidal anti-inflammatory drugs (P = .71) among groups. CONCLUSION: Arthrocentesis alone is as efficacious as arthrocentesis with HA or CS in decreasing TMJ pain.

Arthroscopy of the Temporomandibular Joint in Patients With Juvenile Idiopathic Arthritis.

PURPOSE: The early diagnosis of temporomandibular joint (TMJ) involvement in patients with juvenile idiopathic arthritis (JIA) before joint destruction and growth disturbances could allow for interceptive treatment. The purpose of this article is to report early TMJ arthroscopic findings in patients with JIA. PATIENTS AND METHODS: This was a case series of 3 patients with JIA treated at the Emory University Division of Oral and Maxillofacial Surgery from July 2011 through December 2012. Patients were included if they had a confirmed diagnosis of JIA, did not respond to anti-rheumatologic medication, and had TMJ pain or limited mouth opening. All patients underwent TMJ arthroscopy with an injection of triamcinolone hexacetonide. Demographics, medical history, magnetic resonance imaging findings, arthroscopic findings, and postoperative course were reported. RESULTS: Three female patients (mean age, 12.5 yr; 5 joints) underwent arthroscopy. Arthroscopic findings consisted of mild to moderate synovitis and grade 2 to 4 chondromalacia with or without fibrosis. Postoperatively, all patients had improvement in pain and mouth opening. CONCLUSIONS: There was a positive correlation between duration of JIA activity in the TMJ and severity of arthroscopic findings. Arthroscopic lysis and lavage combined with triamcinolone hexacetonide injection resulted in improvement in pain and range of motion.

Can Preoperative Psychological Assessment Predict Outcomes After Temporomandibular Joint Arthroscopy?

PURPOSE: Psychological assessment has been used successfully to predict patient outcomes after cardiothoracic and bariatric surgery. The purpose of this study was to determine whether preoperative psychological assessment could be used to predict patient outcomes after temporomandibular joint arthroscopy. MATERIALS AND METHODS: Consecutive patients with temporomandibular dysfunction (TMD) who could benefit from arthroscopy were enrolled in a prospective cohort study. All patients completed the Millon Behavior Medicine Diagnostic survey before surgery. The primary predictor variable was the preoperative psychological scores. The primary outcome variable was the difference in pain between the pre- and postoperative periods. The Spearman rank correlation coefficient and the Pearson product-moment correlation were used to determine the association between psychological factors and change in pain. Univariable and multivariable analyses were performed using a mixed-effects linear model and multiple linear regression. A P value of .05 was considered significant. RESULTS: Eighty-six patients were enrolled in the study. Seventy-five patients completed the study and were included in the final analyses. The mean change in visual analog scale (VAS) pain score 1 month after arthroscopy was -15.4 points (95% confidence interval, -6.0 to -24.7; P < .001). Jaw function also improved after surgery (P < .001). No association between change in VAS pain score and each of the 5 preoperative psychological factors was identified with univariable correlation analyses. Multivariable analyses identified that a greater pain decrease was associated with a longer duration of preoperative symptoms (P = .054) and lower chronic anxiety (P = .064). CONCLUSIONS: This study has identified a weak association between chronic anxiety and the magnitude of pain decrease after arthroscopy for TMD. Further studies are needed to clarify the role of chronic anxiety in the outcome after surgical procedures for the treatment of TMD.

What is the risk of future extraction of asymptomatic third molars? A systematic review.

PURPOSE: The purpose of our report was to determine clinically whether young adults who elect to retain their asymptomatic third molars (M3s) have a risk of undergoing 1 or more M3 extractions in the future. MATERIALS AND METHODS: To address our clinical question, we designed and implemented a systematic review. The studies included in the present review were prospective, had a sample size of 50 subjects or more with at least 1 asymptomatic M3, and had at least 12 months of follow-up data available. The primary study variables were the follow-up duration (in years) and the number of M3s extracted by the end of the follow-up period or the number of subjects who required at least one M3 extraction. The annual and cumulative incidence rates of M3 removal were estimated. RESULTS: Seven studies met the inclusion criteria. The samples sizes ranged from 70 to 821 subjects, and the follow-up period ranged from 1 to 18 years. The mean incidence rate for M3 extraction of previously asymptomatic M3s was 3.0% annually (range 1 to 9%). The cumulative incidence rate for M3 removal ranged from 5% at 1 year to 64% at 18 years. The reasons for extraction were caries, periodontal disease, and other inflammatory conditions. CONCLUSIONS: The cumulative risk of M3 extraction for young adults with asymptomatic M3s is sufficiently high to warrant its consideration when reviewing the risks and benefits of M3 retention as a management strategy.

Mandibular fractures treated with small plates and screws reduce treatment cost.

PURPOSE: The efficacy of treating mandibular fractures with open reduction and internal fixation (ORIF) using small titanium plates and monocortical screws is well established. The purpose of this study was to determine whether the use of semirigid (small) titanium plates results in lower treatment charges. PATIENTS AND METHODS: Consecutive patients with mandibular fractures were randomly allocated to ORIF with small or large titanium plates. The primary predictor variable for this secondary subset analysis was plate size. The primary outcome variable was total treatment charges. Other outcomes included length of stay (LOS), operating room charges, hardware charges, LOS charge, and charges related to the treatment of complications. RESULTS: A total of 127 consecutive patients were enrolled in the study. Fifty-two patients completed the required 6-week follow-up and had data available for analysis. Adjusted total treatment charges suggested a significant difference, with a mean total treatment charge of $15,308 in the semirigid group and a mean total treatment charge of $16,557 in the rigid group (P = .04). Total treatment charges were 8% higher in the rigid group compared with the semirigid group. CONCLUSIONS: The findings of this study suggest that the overall charges associated with treating mandibular fractures with ORIF are significantly lower when semirigid plates are used.

Proceedings from the 2013 American Association of Oral and Maxillofacial Surgeons Research Summit.

The American Association of Oral and Maxillofacial Surgeons, the Oral and Maxillofacial Surgery Foundation, and the International Association of Oral and Maxillofacial Surgeons sponsored the fifth research summit, which convened on May 2 and 3 in Rosemont, Illinois. The Research Summits are convened biennially to facilitate the discussion and collaboration of oral and maxillofacial surgeons with clinical and basic science researchers in fields affecting the specialty. The goal is to advance the field of oral and maxillofacial surgery through exposure and education in topics that ultimately benefit the oral and maxillofacial surgical patient. This edition of the research summit included the topics of robotic surgery and antiresorptive-related osteonecrosis of the jaws (ARONJ). Most importantly, this research summit saw the development of research interest groups (RIGs) in the fields of anesthesia, maxillofacial oncology and reconstructive surgery, obstructive sleep apnea and orthognathic surgery, temporomandibular joint surgery, and trauma. These RIGs developed specific research goals with a plan to continue working on potential projects at the AAOMS Clinical Trials Course on May 7 to 9, 2013 at the University of Michigan in Ann Arbor. The summit program was developed by the AAOMS Committee on Research Planning and Technology Assessment. The charge of the committee is to encourage and promote research within the specialty and to encourage interdisciplinary collaboration. The research summit serves as a platform for oral and maxillofacial surgeons to lead the goal of advancement of research relevant to the specialty. This article provides an overview of the presentations that were made in the sessions on robotic surgery and ARONJ. The research summit keynote address and two additional presentations on patient registries are summarized and updates from the RIGs that were formed at the 2013 research summit are highlighted.

An integrated understanding of the physiological response to elevated extracellular phosphate.

Recent studies have suggested that changes in serum phosphate levels influence pathological states associated with aging such as cancer, bone metabolism, and cardiovascular function, even in individuals with normal renal function. The causes are only beginning to be elucidated but are likely a combination of endocrine, paracrine, autocrine, and cell autonomous effects. We have used an integrated quantitative biology approach, combining transcriptomics and proteomics to define a multi-phase, extracellular phosphate-induced, signaling network in pre-osteoblasts as well as primary human and mouse mesenchymal stromal cells. We identified a rapid mitogenic response stimulated by elevated phosphate that results in the induction of immediate early genes including c-fos. The mechanism of activation requires FGF receptor signaling followed by stimulation of N-Ras and activation of AP-1 and serum response elements. A distinct long-term response also requires FGF receptor signaling and results in N-Ras activation and expression of genes and secretion of proteins involved in matrix regulation, calcification, and angiogenesis. The late response is synergistically enhanced by addition of FGF23 peptide. The intermediate phase results in increased oxidative phosphorylation and ATP production and is necessary for the late response providing a functional link between the phases. Collectively, the results define elevated phosphate, as a mitogen and define specific mechanisms by which phosphate stimulates proliferation and matrix regulation. Our approach provides a comprehensive understanding of the cellular response to elevated extracellular phosphate, functionally connecting temporally coordinated signaling, transcriptional, and metabolic events with changes in long-term cell behavior.

Irrigating drains for severe odontogenic infections do not improve outcome.

PURPOSE: The need to irrigate surgical drains in the postoperative period in patients with odontogenic infections is controversial. The purpose of this study was to evaluate the efficacy of irrigating surgical drains postoperatively in patients with severe odontogenic infections. MATERIALS AND METHODS: Consecutive patients presenting with severe odontogenic infections who required incision and drainage were randomized to irrigating drains (red rubber catheters) or nonirrigating drains (Penrose drains). The primary predictor variable was the type of drain and the use of postoperative irrigation. The primary outcome variable was length of stay. Secondary outcomes included postoperative temperature, need for additional procedures, and complications. The t test was used for the primary outcome, and a P value lower than .05 was considered statistically significant. RESULTS: Forty-six patients completed the study. There was no statistically significant difference in overall length of stay, length of stay after surgery, temperature, or need for additional procedures between the 2 treatment groups. CONCLUSIONS: The use of nonirrigating drains appears to be equally efficacious as irrigating drains in the management of severe odontogenic infection.

Small and large titanium plates are equally effective for treating mandible fractures.

PURPOSE: The use of small titanium plates for the management of mandibular fractures continues to be a source of controversy because of their load-sharing properties. The purpose of the present study was to determine whether the use of small plates for mandibular fractures is as efficacious as large plates in a large level I trauma center. MATERIALS AND METHODS: Consecutive subjects presenting with mandibular fractures were randomly allocated to the use of either small plates (group 1) or large plates (group 2). The primary predictor variable was the plate size. The primary outcome variable was fracture union. The secondary outcomes included complications and operative time. Statistical analysis was performed using the Wilcoxon rank sum test for ordinal and continuous variables and the χ(2) test or Fisher exact test for proportions. RESULTS: A total of 127 consecutive subjects with a fracture of the mandible were enrolled in the study. Of the 127 subjects, 53 completed the required follow-up of at least 6 weeks. There was no difference in the rate of fracture union between the 2 groups (P = .95). CONCLUSIONS: The study findings suggest that the use of small plates and monocortical screws for mandibular fractures results in favorable outcomes compared with using larger plates and bicortical screws.

Use of opioids in long-term management of temporomandibular joint dysfunction.

The long-term treatment of patients with chronic temporomandibular joint dysfunction has been challenging. The long-term use of opioids in these patients can be neither supported nor refuted based on current evidence. However, evidence is available to support the long-term use of opioids in other chronic noncancer pain states with reduced pain, improved function, and improved quality of life. One group of patients with chronic temporomandibular joint pain, for whom both noninvasive and invasive treatment has failed, might benefit from long-term opioid medication. The choices include morphine, fentanyl, oxycodone, tramadol, hydrocodone, and methadone. Adjunct medication, including antidepressant and anticonvulsant drugs, can also be used. The safety of these medications has been well established, but the potential for adverse drug-related behavior does exist, requiring appropriate patient selection, adequate monitoring, and intervention when needed.