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Children clinical trials

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NCT ID: NCT04834427 Enrolling by invitation - Postoperative Pain Clinical Trials

Safety and Efficacy Evaluation of S (+) - Ketamine in Children

Start date: April 20, 2022
Phase: Phase 4
Study type: Interventional

A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in children in perioperative settings.

NCT ID: NCT04831593 Active, not recruiting - Surgery Clinical Trials

The Rate of Full and Empty Stomach in Elective and Emergency Pediatric Patients

Start date: April 1, 2021
Phase:
Study type: Observational

Background and Aim: Pulmonary aspiration of gastric content in the perioperative period is rare, but it is an important cause of morbidity and mortality that anesthetists never want to encounter. Due to reasons such as emergency surgical procedures, communication problems with pediatric patients or their parents, impaired cognitive function, obesity, diabetes mellitus, chronic liver and kidney diseases, it is observed that there is sometimes inconsistency between the periods defined in the preoperative fasting guidelines in pediatric patients and the state of gastric content and volume encountered in clinical practice. There is a lack of data on children on this issue. In this study, primary we aimed to evaluate the incidence of empty and full stomach in pediatric patients who underwent elective and emergency surgery in our routine anesthesia practice. Also we want to determine the relationship between fasting time and qualitative assessment of gastric content. Secondary this study sought to examine whether correlation between gastric ultrasound finding and fasting time, and also to determine relationship with the current comorbidities. Design: This is a prospective, single blinded, observational study. The minimum sample size required to determine the prevalence of full stomach, 0.05, within the limits of ± 0.025 with 0.95 confidence, was calculated as 292. When calculating with the proposed equation of n = 100 + 50i to determine the factors affecting by logistic regression (here i is the number of variables in the model), the minimum number of samples required for logistic regression analysis was calculated as 300 in case of 4 independent variables in the model. n=100+50*4= 300 Methods: Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia at our hospital are enrolled in this prospective observational study between April and December 2021. Preoperative ultrasound examination of the gastric antrum are performed by one anesthesiologist who has been instructed and supervised by an experienced pediatric radiologist and who is blind to the patient's history. Ultrasonographic measurement of the gastric antral cross-sectional area (CSA) are performed in supine position and right lateral decubitus position (RLD). The gastric antrum is imaged in a sagittal plane, between the left lobe of the liver and the pancreas, at the level of the aorta, as previously described [1]. This examination allowed qualitative assessment of gastric contents according to the three-point grading scale previously described by Perlas and colleagues[2]. Grade 0 was defined by the absence of appearance of any content in a flat antrum in both the supine and the RLD positions. Grade 1 was defined by the appearance of any gastric content in the RLD position only, and Grade 2 was defined by the appearance of any content in both the RLD and the supine positions. The antral cross-sectional area is also calculated in both position, by measuring the longitudinal diameter (D1) and the anteroposterior diameter (D2) of the antrum, from serosa to serosa using this formula [3] Antral area= (π x D1 X D2) / 4. Patients' characteristic data ( age, gender, weight, height, BMI and ASA physical status classification), fasting duration, type of elective and emergency surgery, chronic disease and complications (regurgitation, pulmonary aspiration, etc.) that may develop during the peroperative period are recorded.

NCT ID: NCT04763733 Completed - Children Clinical Trials

Laparoscopic Splenectomy in Children

splenectomy
Start date: January 2, 2012
Phase: Phase 1
Study type: Interventional

Laparoscopic splenectomy (LS) gained popularity since it has been described for the first-time during nineties of past century. It has become "golden method" for splenectomy in all ages including children

NCT ID: NCT04714255 Completed - Pain Clinical Trials

Efficacy of Art Intervention on Decreasing Pain and Anxiety During Intravenous Cannulation

Start date: November 3, 2019
Phase: N/A
Study type: Interventional

Peripheral Intravenous Cannulation (PIVC), one of the most common therapeutic procedures in medical care, can be difficult even for experienced medical practitioners. The pain of intravenous cannulation is considered the major limitation in pediatric clinical care. Reducing the pain of intravenous cannulation has been the motive for many investigations. Intervention methods used to reduce the distress related to painful procedures are widely recommended. The management of pain and anxiety is more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture-related pain and distress, with strong evidence supporting its efficacy in children. Art therapy commonly used to reduce pain and anxiety of children's disease but was not used in reducing distress outcomes of painful procedures. We used a collection of the image need for coloring and tracing called Trace Image and Coloring for Kids-Book (TICK-B). The purpose of this study is to exam the effectiveness of TICK-B in decreasing pain and anxiety during cannulation.

NCT ID: NCT04693949 Recruiting - Children Clinical Trials

Effect of Nano-structured Alumina Coating on the Bond Strength of Zirconia Resin-bonded Fixed Dental Prostheses

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical outcome of resin-bonded fixed dental prostheses (RBFDPs) pretreated with nanostructured alumina coating (NAC). The study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) (control) as a surface pretreatment method of zirconia RBFDPs used for replacing missing central or lateral incisors. The primary outcome evaluated is the retention/survival of the zirconia RBFDPs pretreated with APA and NAC.

NCT ID: NCT04608968 Recruiting - Children Clinical Trials

Pediatric Perioperative Satisfaction Questionnaire

Start date: September 1, 2020
Phase:
Study type: Observational

The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.

NCT ID: NCT04558710 Completed - Type 1 Diabetes Clinical Trials

The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes

Start date: June 1, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months. The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.

NCT ID: NCT04430673 Completed - Children Clinical Trials

Virtual Rehabilitation Innovations for Motivation

VR4REHAB-MOT
Start date: February 22, 2021
Phase: N/A
Study type: Interventional

Children and young people with movement difficulties such as Cerebral Palsy (CP) and Acquired Brain Injury (ABI) report that traditional therapies are highly repetitive and labourious. This influences enjoyment and participation in regular therapy programmes and may result in reduced adherence to therapy or exercise regimes, limiting effectiveness. This study will build on the team's previous work to explore the potential use of Virtual-Reality (VR) technologies in rehabilitation; particularly systems that can be used at home to increase accessibility and reduce need to attend clinics for therapy. During the co-production events of the VR4REHAB Inter Regional North West Europe (NWE) funded programme in 2018, young people desired the use of commercial games for therapeutic purposes. This work has enabled connections between affordable computer technologies: the Raspberry Pi, VR headsets and freely available commercial games. This 2-Phased project is therefore exploring the potential of commercially available virtual reality (VR) systems consoles and games for use in rehabilitation programmes. The Investigators hope to gain information on: 1. Whether commercially produced VR games can provide a motivating environment to support adherence to therapy 2. Whether it is possible to improve reaching and grasp-release hand movements through this method 3. Gain an understanding of the ages of children and young people most likely to benefit from home-based VR therapy User evaluation and performance data and therapist evaluations will be collected and compared to baseline data to provide information on usability, accessibility, acceptability and adaptability.

NCT ID: NCT04422782 Recruiting - Children Clinical Trials

New Tools for Predicting Capillary Leak Shock During Dengue Fever

PrediDengue
Start date: May 14, 2020
Phase: N/A
Study type: Interventional

Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.

NCT ID: NCT04422483 Recruiting - Autism Clinical Trials

A Realist Evaluation of Autism ServiCe Delivery (RE-ASCeD)

Re-ASCed
Start date: November 30, 2019
Phase:
Study type: Observational

Diagnostic pathways for children with possible autism. Which work best, for whom, when, and at what cost? Autism is a complex neuro-behaviour condition. People with autism have difficulty with social interaction and in communication with others. They may struggle with change, and repeat actions over and over. Life may be very anxious or stressful. The signs of autism can occur at any age but often appear in the first two years of life. There is no one type of autism, but many, so the condition is now called autism spectrum disorder (ASD). Autism is lifelong but this study is only about children. Caring for a child with autism can be difficult and can sometimes be tough on the whole family. This project aims to guide the people who plan services for families and children. Different teams and services that do autism assessments will help us. The investigators will ask teams and services: What speeds up diagnosis? What delays diagnosis? The study will be in four work packages: 1. The investigators will review research in the UK and abroad to find evidence and ideas that will help speed up diagnosis. 2. The investigators will survey professionals who work for the specialist teams who diagnose autism. The survey will be about each step in the process and ask which professionals get involved. The investigators will ask about the number of children they see and the time it usually takes to reach a diagnosis. This will give us a picture of the national situation. 3. After the national survey, the investigators will select around six or eight teams. These teams will be using different and innovative approaches. The investigators will study those approaches. The investigators will talk to clinical staff, managers, referrers, parents and young people. Parents and young people will have gone through the diagnostic process. The investigators will ask parents and young people about their experiences and views. The investigators will review the steps in the diagnosis process for about 70 children in each service. The investigators will find out how long each assessment takes, how much clinical time it takes, and how much it costs. The investigators will compare findings across teams and services. 4. The investigators will have national meetings with autism experts and patient groups. The investigators will show them our findings. These groups will agree recommendations for practice. Clinical teams, service managers, commissioners, parents' groups, and NHS England will receive recommendations. The research team has specialist expertise in autism, health services, economics, and statistics. The team includes public and NHS England partners. This will ensure the investigators take account of the needs of families and the investigators send the findings to people who plan services.