12 Clinical Trials for Various Conditions
Functional abdominal pain (FAP) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. The study will test a treatment approach which, if successful, would substantially change the treatment for FAP and potentially for a wide range of childhood medical problems where parental responses to symptoms contribute to these adverse effects. The study would also provide a model which would be much more accessible than traditional face-to-face therapies to a broader range of families in need than are currently served.
Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered. This innovative project will be a template for extending EHR-based clinical decision support to other domains of emergency care to ultimately improve a broad range of pediatric acute care outcomes. The proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain.
Functional abdominal pain (FAP), a pediatric pain condition without significant organic pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood. This project aims to identify child and family characteristics that predict differential responses to a Cognitive Behavior Therapy intervention administered online to patients with FAP and their parents. The goal is to acquire scientific knowledge to guide individualized treatment of patients with FAP.
IND application was submitted to FDA on November 17th.
Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in adults, it is one of the functional bowel disorders without a clear framework of understanding or an effective treatment. However, new research suggests that small intestinal bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor to IBS in adults, we hypothesize that children with this disorder have a significantly greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To prove this, we will first aim to determine the prevalence of SIBO in both healthy children and those with CAP. We will do this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To do this we will randomize, in a double-blinded fashion, the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a placebo. After completion of the treatment we will evaluate all these patients for eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will also assess for symptom improvement by re-administering questionnaires.
The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are: Aim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics). Aim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms. Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.
The purpose of this study is find out if we can use simple tests (biomarkers) to tell us if a specific child would benefit most from CBT or from the low FODMAPs diet.
Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.
This protocol matches child subjects with peer mentors of similar age who have learned to function successfully with a chronic pain disorder. The trained mentors will present information to the subjects in a supervised and monitored interaction via telephone and computer for 2 months and encourage participation in skill-building programs. Children will be tested for improvement in pain and functioning at 2 months and again at 4 months to see if improvements persist. The investigators hypothesize that children who received peer mentor support will show more improvement in pain and functioning at 2 and 4 months into treatment than those in a control group who do not receive mentor support.
The purpose of this research study is to compare the safety and effectiveness of three commonly used techniques for delivering anesthesia during a procedure known as esophagogastroduodenoscopy.
Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.
Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.