56 Clinical Trials for Various Conditions
The purpose of this study is to analyze Fitbit data to predict infection after surgery for complicated appendicitis and the effect this prediction has on clinician decision making.
UIC Division of pediatric surgery has IRB approval to perform retrospective and prospective study of their pediatric surgical patients. At UIC Dr. Lobe performed the first known single port robotic splenectomy on a child and as a surgical first this case is worthy of a case report. Since it is a surgical and therapeutic first it needs to be aon regestiry of health research prior to publication.
The purpose of this research study is to determine the number of children who have symptoms of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed concussion. This study is the first phase of a two-part study looking at the effects of anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently, the decision to continue with surgery in patients with a diagnosed concussion is based on clinical judgment by the patients.
Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it does in the body) and pharmacodynamics (how it works) have not been well established in children. Some children, because of their specific genetic make-up, may metabolize the drug more quickly and therefore may be at risk for more side effects in the commonly prescribed dose. We would like to find out more about how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, we would like to give oxycodone to surgical patients at Boston Children's Hospital then measure its metabolic activity and also perform a genetic analysis. The genetic testing is specifically to analyze the following genotypes only: cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4), which represent the differences in cytochrome P450 metabolism of oxycodone.
This is a retrospective chart review to assess the incidence and the degree of blood pressure changes after induction of anesthesia and to study the effect of different induction agents on blood pressure.
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in pediatric cardiac patients in whom fibrinogen supplementation is indicated. The investigators' hypothesis is that fibrinogen concentrate will be as effective as cryoprecipitate in achieving adequate hemostasis after separation from CPB in pediatric cardiac surgery patients. Study Design: this will be a single-center, prospective, randomized, active-control study in pediatric (24 months of age or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM). Informed consent will be obtained from a parent or a legal guardian prior to surgery and anesthesia. Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group): 1. Cryoprecipitate group (dose: 10 ml/kg; active control group) or 2. Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecipitate will be administered to all study subjects (including those who received FC). The results of this study will be used for publication as well as the first stage towards a significantly larger randomized multi-center trial (see below). Based on the results of this pilot study the investigators plan to conduct a large multi-center, randomized active-control non-inferiority trial in the future, comparing the use of FC to cryoprecipitate in a much larger cohort of pediatric patients undergoing cardiac surgery with CPB. Ultimately, the results of this trial are likely to improve the care of pediatric cardiac surgical patients experiencing post-CPB bleeding, an under-studied yet high-risk patient population.
Providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. Even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects. The erector spinae plane block (ESPB) is a newly described fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Additionally, there are case reports describing the ESPB as part of a multi-modal analgesic plan in adult degenerative spine surgery as well as adult spinal deformity surgery, demonstrating effective analgesia and no clinical motor blockade. Although it is known that the inflammatory reaction plays a crucial role in the mechanism of acute pain after major surgery, the effectiveness of the current regional approach on inflammatory response is not well studied.
The investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period as compared to usual care. This study will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for the use of cardiopulmonary bypass.
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of vancomycin and cefazolin pharmacokinetics in children undergoing cardiopulmonary bypass (CPB) 3) to assess the barriers to vancomycin dosing peri-operatively 4) to assess side effects and risks associated with peri-operative vancomycin administration. This will allow us to improve patient care by better understanding the benefits or the risks of peri-operative vancomycin administration and potentially decrease cefazolin-resistant surgical site infections. In addition, this study gives us the opportunity to evaluate cefazolin and vancomycin pharmacokinetics (pK) on children on CPB. The investigators will take blood samples from 20 patients. In 10 patients the investigators will do Cefazolin pK analysis and in the other 10 the investigators will do pK Vancomycin analysis. For the remainder of 292 patients, only prospective chart review will be done to determine the incidence of SSIs. This data will be compared with 936 controls who received only Cefazolin pre-operatively as prophylaxis for SSI's. --------------------------------------------------------------------------------
Cardiac surgery requiring use of a heart-lung machine, also known as cardiopulmonary bypass (CPB) can induce abnormalities in blood coagulation (clotting) that lead to excessive blood loss during and after operation. While of significant concern in adults, this problem takes on even greater importance in children due to the simple fact that they have a smaller blood volume. It is well known that if a child has previously undergone a heart operation, they are at increased risk of bleeding should more cardiac surgery be required ("reoperation"). The processes regulating blood coagulation are extraordinarily complex, and little is known about the exact mechanisms that contribute to the increased bleeding associated with cardiac reoperation in children. Rotational thromboelastometry (ROTEM®) is a technology that can provide, at the bedside, detailed information about coagulation abnormalities. While not currently approved for general use in the United States, in Europe ROTEM® has been used to guide administration of the blood products in surgery based upon determination of specific coagulation abnormalities. Importantly, there is now evidence that guidelines for transfusion therapy based on ROTEM® reduce transfusion requirements thus decreasing patient exposure to blood products. Whether the use of ROTEM® has potential benefit for pediatric cardiac surgical patients has not been studied. Accordingly, the present study was designed to provide preliminary data comparing coagulation profiles between children undergoing cardiac reoperation to those having primary procedure. The investigators hypothesize that ROTEM® analysis will detect a pattern of impaired coagulation in children undergoing reoperation. The overall objective of the four assays of ROTEM® analysis therefore, is to provide information that can be used to devise a rational transfusion protocol for pediatric cardiac surgical subjects.
Patient demographics (age, height and weight) will be collected for 546 consecutive patients presenting for dental restoration under general anesthesia. The baseline saturation will be recorded. The induction of anesthesia will be standardized for all patients. All patients will undergo an inhalational induction administered by face mask. After inserting an intravenous (IV) line, rocuronium will be administered. Intravenous propofol and fentanyl could be added at the discretion of the anesthesiologist. The patients will be mask ventilated then be with a mixture of Air/Oxygen (O2) to achieve an FiO2 of 0.3 for 3 minutes after the administration of rocuronium. Patients will be randomly assigned to one of three groups for the purpose of airway management: 1) direct laryngoscopy for nasotracheal intubation without oxygen insufflation (DL group); 2) direct laryngoscopy for nasotracheal intubation with oxygen insufflation (DLO2 Group); and 3) nasotracheal intubation using the Truview PCD video laryngoscope (VL Group). Computer-generated treatment allocations (using the PLAN procedure in SAS statistical software, using random-sized blocks) will be maintained in sequentially numbered sealed envelopes that will be opened after consent is obtained. The laryngoscopy and intubations will be performed by the study investigators who are faculty anesthesiologists or by the mid-level or resident or fellow working with them. The study will be stopped when: * the patient will be intubated and a CO2 trace is obtained on the capnography or * if the patient desaturates to 90% * or if the patient shows signs of cardiac instability (ectopic beats, arrhythmia or hypotension) Randomized groups will be compared for balance on potentially confounding baseline variables using descriptive statistics. Primary outcome: In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop. We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcomes. Thus our primary hypothesis will be assessed in a joint hypothesis testing framework described by Mascha and Turan. We a-priori define the non-inferiority delta for the outcome time to 1% drop as 5 seconds (or 1.05 if using hazard ratio) and the slope delta as 0.05 percent per second.
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal limitations. Current literature indicates pain as a common experience for children with CP but has been understudied in this population. Moreover, inadequate post-operative pain control can result in negative physiologic and psychological complications and lead to poor surgical outcomes. Currently, perioperative pain management following orthopaedic procedures in pediatric patients follows traditional protocols that rely on the administration of opioid medications despite their known adverse side effects including nausea, vomiting, itching, constipation, urinary retention, confusion, and respiratory depression. Epidural anesthesia is a key modality in traditional pain management for pediatric patients with CP given its proven efficacy in decreasing pain and managing spasticity. Yet, administering epidural anesthesia in this patient population poses several risks including damage to preexisting intrathecal baclofen pumps, iatrogenic infection, and technically demanding insertion given high rates of concomitant neuromuscular scoliosis. Alternatively, multimodal analgesic injections theoretically offer an efficacious adjunct to traditional pain management protocols with a lower risk profile. Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo showed decreased pain scores and narcotic consumption postoperatively in this patient population. Based on these promising results, the objective of this randomized control trial is to evaluate the efficacy of a multimodal surgical site injection compared to epidural anesthesia for postoperative pain control following operative management of hip dysplasia in pediatric patients with CP.
The goal of this pilot prospective cohort study is to examine the reproducibility of gastric volume and emptying as measured by gastric ultrasound and its correlation to a gold-standard test for gastric emptying in the perioperative period in pediatric patients. The main questions it aims to answer are: * What is the reliability (inter-rater variability between expert and novice assessors, and intra-rater variability) of a) the gastric antral cross-sectional area (CSA) and b) gastric volume using the Perlas US qualitative grading assessment, measured by using an ultrasound device in pediatric patients undergoing general anesthesia for elective surgery? * What is the correlation between ultrasound assessment of gastric emptying by the antral-CSA and gastric emptying determined by the acetaminophen absorption test (AAT), the gold standard? The study will include two cohorts. Cohort assignment will be based on age and anesthesia induction plan. Subjects \>7yrs of age and expected to get an IV induction will be assigned to Cohort #1. Subjects \<7yrs of age and not expected to get an IV induction will be assigned to Cohort #2. * Cohort 1 will include abdominal ultrasound for gastric assessment AND the acetaminophen absorption test which includes administering enteral acetaminophen (tylenol) with 6 oz of water and drawing of blood samples through a peripheral intravenous line. * Cohort 2 will include subjects for whom a peripheral intravenous line placement is not part of routine pre-operative care. Procedures for Cohort 2 will include abdominal ultrasound only in the pre-op area (no tylenol). This cohort is included to examine the reliability of measurements across age groups.
Randomized study to assess the impact of supplemental educational YouTube videos on postoperative healthcare utilization following ambulatory pediatric urologic surgery
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.
Opioids are an important component of post-operative pain management among children, but are often prescribed in excess and rarely disposed of appropriately. The lack of prompt and proper opioid disposal after recovery from surgery is contributing to the opioid crisis in Ohio by placing children at risk of accidental ingestion of opioids remaining in the home and allowing for unused opioids to be diverted for non-medical use. The investigators propose to reduce the burden of the opioid crisis in Ohio by testing a strategy to increase proper opioid disposal by families of children undergoing outpatient surgery. The investigators will test the impact of a novel opioid disposal mechanism, the Deterra® drug deactivation system, after pediatric surgical operations. This system deactivates pills, liquids, or patches, allowing for their disposal in the home garbage. The investigators propose to evaluate the effectiveness of providing Deterra® bags to families of children having surgery on their disposal of excess opioids. The investigators will perform a randomized controlled trial (RCT) to test the effectiveness of Deterra® to improve opioid disposal among families of children having outpatient surgery at Nationwide Children's Hospital.
This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.
1. The aim of this study is to assess anxiety in pediatric patients preoperatively, perioperatively, and postoperatively and whether meditation reduces anxiety in the days before, during, and after the surgery. 2. The second aim of this study is to see if longitudinal meditation is associated with decreased postoperative pain by examining whether the group prescribed meditation has reduced pain medication intake, measured by the frequency of liquid analgesic medicine intake.
This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.
The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery or laser treatment under anesthesia.
The purpose of this study is to determine if methadone improves postoperative pain control in pediatric patient's undergoing cardiac surgery.
The purpose of this study is to find a more accurate postoperative pain assessment for teenager patients. This is important because a patient should not have a very strong pain medication such as morphine if the pain is just mild.
The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and compare obtained results versus standard laboratory coagulation parameters prothrombin time (PT) and partial thromboplastin time (PTT). The time difference in obtaining the two results will also be examined. A total of 100 pediatric patients undergoing spinal surgery or cardiopulmonary bypass will be enrolled and consented per protocol. Blood samples will be obtained simultaneously tested on both the standard laboratory apparatus and the Coagcheck® device. If the two results are comparable, this could have immediate clinical application and impact in the operating room as POCT results are available within 2-3 minutes compared to 1-2 hours for standard laboratory samples.
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major Elective Surgery. It will be conducted at approximately 5 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of 19 months, and the study population will consist of at least 60 male and female pediatric subjects between 0 days and 12 years of age, undergoing cardiac, abdominal, orthopedic or transplant surgery with an approximately equal number of subjects (n=10 to 25) in three of the four age groups: (29 days to 23 months), (2 to 5 years 11 months) and (6 years to 12 years) cohorts.
Children (ages 0-12) that have heart surgery are often at a high risk of developing complications and have to be continuously monitored. Part of the routine care at UCLA includes using a monitor (continuous central venous oxygen saturation-ScvO2) to measure the amount of oxygen saturation in the tissues (indirectly) during surgery and in the intensive care unit. However, there is not much data on the use and effectiveness of this monitor in comparison to other monitors used for children. The purpose of this study is to further evaluate the effectiveness of the continuous central venous oxygen saturation (ScvO2) monitor in children and compare it with other monitors during a heart surgery. This is an observational study and the patients will not undergo any research specific procedures in the operating room (OR). The investigators will observe and record de-identified information, such as vital signs (heart rate, blood pressure, etc.), to evaluate the importance of the monitor. This study will also look at the demographics (age, gender, diagnosis, etc.) and treatments (type of surgery) received children undergoing heart surgery to improve quality of care. The investigators will also observe the same parameters in the ICU. The investigators hypothesized that low central venous saturations are associated with worse clinical outcomes.
Recently, a paper was published that compared outcomes of patients requiring repair of aortic coarctation and ventricular septal defect. Some surgeons opt to repair both defects in one surgery while other surgeons do the repair in two separate operations. Recently at Children's Healthcare of Atlanta, we have adopted the practice of correcting both defects during the same operation but through two separate incisions (one on the chest and the other through the ribs on the side. This reduces the amount of time the patient is on the heart-lung bypass machine during surgery. This study is a review of patient charts to compare outcomes of patients who have had surgery to repair their coarctation and VSD during 2002 through 2005.
We aim that uncovering patients during induction of general anesthesia does not decrease core body temperature in pediatric patients.
The study objective is to decrease neonatal mortality and morbidity by elucidating the etiology of system failures during perioperative care. In Aim 1 the investigators will use a novel event discovery method, based on the construct of the nonroutine event (NRE), to efficiently capture dysfunctional clinical microsystem attributes and potentially dangerous conditions. A NRE is defined as any event that is perceived by care providers or skilled observers as a deviation from optimal care based on the clinical situation. In Aim 2, the investigators will perform a comparative analysis of prospectively collected NRE data to the data collected by conventional event reporting methodologies. In Aim 3 the investigators will collaborate with Primary Children's Hospital (PCH) in Salt Lake City, UT to conduct practical pilot testing of tools and measures developed and refined in the first two Aims. Products from Aims 1 \& 2 will include: 1. a taxonomy of NREs and outcomes for perioperative neonates; 2. neonatal Comprehensive Open-Ended Non-routine Event Survey (NCONES) data collection tool; 3. comparisons of 5 established event reporting systems, including their rates, costs and benefits; and 4. a guide to prototype neonatal safety surveillance and risk prediction for hospitals and NICUs. Aim 3 will capitalize on PCH's robust network of NICUs, neonatologists, and patient-level outcome data to conduct a pilot implementation evaluation of the methods and tools developed and refined in Aims 1-2.
This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.
The goals of this study are: 1. To evaluate the neuroprotective effect of nitric oxide by measuring glial fibrillary acid protein (GFAP) before and after surgery. GFAP will be analyzed via an enzyme-linked immunosorbent assay (ELISA) kit. Patients will also be monitored post-operatively for delirium in the intensive care unit (ICU). 2. To evaluate the renal protective effect of nitric oxide by measuring neutrophil gelatinase-associated lipocalin (NGAL) before and after surgery. NGAL will also be analyzed via an ELISA kit. Patient creatinine will be monitored post-operatively. 3. To evaluate effect of nitric oxide on other ICU outcomes (invasive mechanical ventilation, days to extubation, ICU and hospital length of stay, and blood product administration).