Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease.

BACKGROUND: This systematic review was performed to characterize the landscape of research conducted in patients with intestinal stoma (IS) and highlight unmet needs for clinical research in Crohn's disease (CD) and IS. METHODS: We searched ClinicalTrials.gov from inception to May 25, 2022, to identify clinical trials assessing interventions in patients with an IS, as well as those with an IS and CD. Studies were grouped according to type of intervention. We excluded observational studies with no treatment arm. RESULTS: A total of 253 studies were included in the final analysis. Most studies investigated devices (n = 122 [48.2%]), or surgical procedures (n = 63 [24.9%]), followed by behavioral interventions (n = 30 [11.8%]), drugs (n = 20 [7.9%]), dietary interventions (n = 2 [0.8%]), skin care products (n = 2 0.8%]), and others (n = 14 [5.5%]). A total of 50.9% (n = 129) of studies had completed recruitment, enrolling 11 116 participants. Only 6 studies (surgery: n = 3; physiological studies: n = 2; drugs: n = 1) exclusively included patients with inflammatory bowel disease (IBD), and 16 studies commented that patients with IBD were excluded in their eligibility criteria. No study assessed efficacy of drugs in patients with CD and IS. Approximately one-quarter of studies (n = 65 of 253) included quality of life as an outcome measure. CONCLUSION: There is a paucity of research in IBD patients with IS, with the majority focusing on devices and surgical procedures. There have been no drug trials evaluating efficacy in patients with CD and IS. There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures that enable the inclusion of patients with CD with stoma into clinical trials.

We analyzed registered trials for patients with intestinal stoma with special focus on Crohn's disease patients to explore research and unmet needs. Our results indicate a scarcity of studies in this area with most studies limited to surgical procedures and devices.

Predictors of triage pain assessment and subsequent pain management among pediatric patients presenting to the emergency department.

BACKGROUND: Pediatric patients with pain of various causes present to the emergency department. Appropriate assessment and management of pain are important aspects of emergency department treatment. However, only a few studies have identified the predictors of both outcomes. This study aimed to evaluate the rate of pain assessment at triage and subsequent management and to identify the predictors of each outcome. METHODS: This was a multi-center retrospective study based at five community emergency departments. Pediatric patients (< 18 years) with pain or injury who presented to the emergency department between February 2018 and May 2018 were included. In addition to patient demographics, the initial pain assessment at triage, reason for visit, and time to analgesia were determined. Further, the type and route of analgesia were identified in patients who received analgesia. Univariate and multivariable regression models were used to identify predictors of pain assessment and management. RESULTS: There were 4,128 patients with an average age of 9.6 years, and 49.1% of them were female. Only 74.2% of the patients underwent assessment for pain at triage, and 18.3% received analgesia. The median time to analgesia was 95 (IQR: 49-154) min. Most patients presented with head/neck (36.1%), upper limb (21.6%), and lower limb (19.9%) pain. The oral route was the most common analgesia delivery method (67.4%), and ibuprofen and acetaminophen were the primary agents used. Younger age, higher acuity, and presenting with head or neck pain were independent predictors of pain assessment at triage, while children 3-5 years and those with lower extremity pain were more likely to receive analgesia. CONCLUSION: Although pain assessment at triage has improved in pediatric patients, there is still a major deficiency in adequate pain management. Our study highlights predictors of pain assessment and management that can be considered for improved pediatric care.