Clinical Research Directory

Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy

Acute appendicitis is the most common surgical emergency in children. Despite the widespread adoption of laparoscopic appendectomy, postoperative care still varies widely between institutions, with prolonged fasting, opioid-based analgesia, delayed feeding, and routine drain placement being common. Enhanced Recovery After Surgery (ERAS) is an evidence-based, multidisciplinary care pathway that has been shown in adults - and increasingly in children - to reduce length of stay, opioid consumption, and postoperative complications. This single-center, prospective, single-arm cohort feasibility study (IDEAL Stage 2a) tests whether a comprehensive 20-item pediatric ERAS protocol, adapted for minimally invasive appendectomy in children aged 5-18 with non-complicated acute appendicitis (ASA I-II), can be implemented with high fidelity and acceptable safety in a tertiary academic pediatric surgery department. We aim to enroll 100 patients to obtain \~80 evaluable cases. The primary endpoint is the global ERAS compliance rate (target ≥80%, with the lower bound of the 95% confidence interval staying above 70%). Co-primary safety endpoints include Clavien-Dindo ≥III complications and 30-day unplanned readmission rates, both targeted at \<5%. Secondary endpoints include time to medical readiness for discharge, actual length of stay, opioid sparing, and parent-reported outcomes. The study includes a structured run-in phase (first 5 patients) with explicit decision logic to either continue with the protocol unchanged or revise it before full enrollment. Audit-and-feedback cycles every 20 patients monitor compliance drift. The findings will inform a definitive institutional clinical guideline and provide hypothesis-generating data for future multi-center trials.

Risk Sharing vs Risk Dumping: Parental Attitudes About Risks

This study will evaluate how parents or legal guardians perceive responsibility for surgical risk after the informed consent discussion for their child's operation, focusing on whether the process feels like "risk sharing" with the clinical team or "risk dumping" onto the parent. In pediatric surgery, parents often serve as surrogate decision-makers, and little is known about how consent conversations shape feelings of support, blame, trust, and decisional burden. Using a mixed-methods, cross-sectional design, the study will recruit parents/legal guardians of children under 18 years of age undergoing pediatric surgical procedures at Comer Children's Hospital after the clinical consent discussion and before surgery. Participants will complete a post-consent survey assessing perceptions of risk sharing versus risk dumping, understanding of risks and benefits, satisfaction with the consent process, trust in the surgeon/institution, decisional conflict, anxiety, and relevant demographic and clinical factors. A subset of participants will also complete semi-structured interviews to further explore experiences of responsibility, blame, institutional support, and suggestions for improving the consent process. The goal is to characterize parental perceptions of responsibility in pediatric surgical consent and identify communication, demographic, and clinical factors associated with greater perceived risk dumping. Findings may help inform interventions to improve informed consent and shared decision-making practices in pediatric surgery.

Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery

The main objective of this study is to study the impact of intravenous dexmedetomidine combined with locoregional anesthesia on postoperative pain in children undergoing surgery. Secondary objectives was to compare beetwen groups : Post-operative pain; opioid consumption; incidence of emergence delirium, post-operative behavioral disorders, length of stay in the PACU, adverse events , parental satisfaction and quality of life.The goal of this clinical trial is to assess intravenous dexmedetomidine to prevent post-operative pain in children undergoing surgery. This study is prospective and children will be randomized in one of the following arm: * Dexmedetomidine (experimental treatment) * Placebo The experimental treatment or placebo will be administrated at one time point at the time of incision. Participants and their legal representative will have to respond to questionnaires at several time points following the surgery: Day 1, Week 1, Month 3 and Month 6.

Impact of Different Fasting Strategies on Gastric Ultrasound and Anxiety Levels in Children

Children who undergo surgery are usually asked to stop eating and drinking for several hours before anesthesia to reduce the risk of stomach contents entering the lungs. However, long fasting times may cause discomfort, dehydration, low blood sugar, and increased anxiety in children. Recent guidelines suggest that clear liquids can safely be allowed closer to the time of surgery, and some enhanced recovery protocols even recommend giving carbohydrate-containing drinks before anesthesia. This study will compare three different preoperative fasting approaches in children undergoing elective inguinoscrotal surgery: traditional fasting, preoperative carbohydrate drinks, and the "Sip-Til-Send" approach, which allows clear fluids until the child is called to the operating room. The children's anxiety levels will be evaluated before surgery using a validated anxiety scale and assess stomach content and volume using gastric ultrasound. including gastric ultrasound findings (antral cross-sectional area, estimated gastric residual volume, and gastric fullness grade), gastric pH, blood glucose levels, and time to discharge readiness assessed using Ped-PADSS, will be evaluated. Additional clinical outcomes, including postoperative nausea, vomiting, pain, and delirium, time to first oral intake, and lengths of stay in the post-anesthesia care unit and hospital, will also be evaluated. The results may help determine safer and more comfortable fasting strategies for children undergoing surgery.

Effect of Intravenous Versus Caudal Dexmedetomidine on Perfusion Index and Hemodynamic Responses in Children Undergoing Infraumbilical Surgery

Caudal anesthesia is widely used to provide pain relief for children undergoing surgery below the navel (infraumbilical surgery). Dexmedetomidine is a medication commonly added to local anesthetics to enhance pain control and reduce stress responses during surgery. It can be given directly into the caudal space or through an intravenous (IV) line into the bloodstream, but it remains unclear which route provides better blood flow regulation and vital sign stability. This study aims to compare the effects of caudal versus intravenous dexmedetomidine on peripheral blood flow, measured non-invasively using the Perfusion Index (PI), as well as heart rate and blood pressure in pediatric patients. A total of 100 children aged 1 to 7 years undergoing elective infraumbilical surgery will be randomly assigned to one of two groups: * Group C (Caudal Group): Receives dexmedetomidine added to the caudal local anesthetic (levobupivacaine) alongside an IV saline placebo infusion. * Group I (Intravenous Group): Receives the caudal local anesthetic alone alongside an IV infusion containing dexmedetomidine. Neither the parents nor the healthcare team will know which study drug regimen the child receives. Investigators will record changes in the Perfusion Index, monitor heart rate and blood pressure throughout surgery and recovery, and evaluate postoperative pain scores and recovery room discharge times.

Virtual Reality for Pediatric Perioperative Preparation

This pilot randomized controlled trial will evaluate whether a virtual reality (VR) preparation program can improve the perioperative experience of children aged 3 to 12 years undergoing elective surgery. Children scheduled for surgery at HM Hospital in Madrid, Spain, will be randomly assigned to receive either a VR-based educational experience (NixiKit) or the standard preoperative preparation routinely provided by nursing staff. The VR intervention includes an immersive virtual tour of the preoperative area, operating room, and recovery room, designed to familiarize children with the surgical process in an age-appropriate manner. The control group will receive the usual verbal explanation and support provided by nurses before surgery. The study will assess children's fear, preoperative anxiety, cooperation during anesthesia induction, and postoperative pain. Parents' experience and satisfaction with care will also be evaluated. The results of this pilot study will help determine the feasibility and potential effectiveness of VR as a nursing-led preparation strategy for pediatric surgical patients.

Pediatric Anesthesia: The Childs Voice

In Denmark, around 25,000 children under 18 undergo general anesthesia annually. Hospital stays and anesthesia can induce significant anxiety and stress in children due to unfamiliar environments, procedures, and communication issues. This anxiety can be linked to postoperative complications such as emergence delirium and may negatively impact both the child and their family's well-being. Engaging patients actively in their healthcare, including pediatric cases, is essential for improving outcomes. Assessing perioperative patient and family outcomes, particularly through patient-reported outcome measures (PROM) and patient-reported experience measures (PREM), can significantly enhance the quality of care provided to children. While PROMs are widely used in adults, they are less common in pediatric settings. The Pediatric Scale for Quality of Recovery (PedSQoR), developed by Australian and American researchers, is one such tool designed to measure recovery in children. This study aims to translate andvalidate the PedSQoR for Danish children aged 4-12. Furthermore, no existing instruments comprehensively assess pediatric surgery patients' experiences under general anesthesia, particularly from the child's perspective without relying on parents as proxies. Empowering children to express their healthcare experiences gives healthcare workers an insight into what matters for children and gives children a more positive outlook on healthcare, benefiting lifelong engagement. Study Aims and Objectives: The study aims to enhance the assessment of children's outcomes and experiences in perioperative settings, ultimately improving pediatric perioperative healthcare. The objectives include: 1. Translation and Adaptation: a. Translate and adapt the PedSQoR for Danish children aged 4-12. b. Validate the Danish PedSQoR version. 2. Development of a PREM Instrument: a. Develop a comprehensive PREM for children's experiences during surgery and anesthesia. b. Pilot-test and adjust the PREM questionnaire with a group of children aged 4-12. Study Methods: 1. PedSQoR Translation and Validation: A single-center prospective cohort study will adapt and test the PedSQoR for Danish children. The process involves translating the 21-item scale, validating it with a sample size of 150, and ensuring reliability through various statistical methods, including Cronbach's Alpha and test-retest reliability. Data will be collected from the Department of Anesthesiology and Intensive Care at Gødstrup Hospital. 2. PREM Instrument Development: This study will develop a PREM instrument using the Warwick Patient Experiences Framework (WaPEF), which encompasses seven dimensions of patient experience. The process will involve forming a panel of child experts, conducting focus groups, and translating insights into a pictorial questionnaire. The PREM will undergo pilot testing with 20 children to validate its effectiveness in capturing the dimensions of the WaPEF. Research Ethics: Given the vulnerability of children in research, this study will prioritize their safety and comfort, ensuring the study's benefits outweigh any potential risks. Informed consent will be obtained from both parents and children. The study will be registered with the Region Central Denmark's list of research projects and will not require approval from the Scientific Ethics Committee.

Bookbased Emotion and Anxiety Reduction

Many children are afraid of surgery and anesthesia. Studies show that up to 60% of children experience significant anxiety before a scheduled procedure. This fear is caused, for example, by the unfamiliar hospital environment, separation from parents, worry about pain, or because they do not know exactly what will happen. Severe anxiety before surgery can complicate the procedure and is linked to higher stress, increased post-operative pain perception, and behavioral changes. This study investigates whether a specially developed, age-appropriate children's book can help reduce anxiety before surgery. The book explains the anesthesia and surgical procedure in a child-friendly way using pictures and simple text. Children aged 4 to 10 who are undergoing surgery at the Inselspital Bern for an inguinal, umbilical, or ventral hernia can participate. A total of 50 children are to be included. The children will be randomly divided into two groups: One group receives the children's book to prepare at home. The other group receives the usual preparation without the book. The children's anxiety is measured using an established observation scale - once during the preliminary examination and again on the day of surgery before anesthesia. In addition, several contributing factors are recorded, such as how well the child cooperates during the induction of anesthesia or how much anesthetic medication is required. Parents will complete a short questionnaire regarding their own anxiety. Participation involves minimal risk. Only a children's book is provided, and the children's behavior is observed. No additional medical interventions are planned. The aim of the study is to test whether a simple, cost-effective, and easily implementable tool - a children's book - can effectively reduce anxiety before surgery. If the book proves to be helpful, it could be routinely used to prepare children for surgery in the future.

Health Literacy in the Perioperative Setting

The purpose of this study is to determine the association of the social determinants of health with perioperative health literacy in caregivers of children presenting for surgery. Another purpose is to determine the association of caregiver health literacy with preoperative caregiver anxiety and postoperative patient pain scores.

Video-Based Grading of Intraoperative Adverse Events in Pediatric Laparoscopic Appendectomy

Acute appendicitis is the most common surgical emergency in children, and laparoscopic appendectomy is its standard treatment. Although intraoperative adverse events (iAEs) are recognized as an important determinant of surgical safety and outcome, no validated tool exists for grading them in children. ClassIntra, an internationally validated five-level severity classification of intraoperative adverse events, has been validated in adults. Its use in children is limited to two single-centre cohorts - one in pediatric neurosurgery and one in a mixed pediatric robotic surgery programme - in which it was applied prospectively by the operating teams. Its inter-rater reliability has never been assessed in a pediatric population, it has not been applied to video-recorded pediatric procedures, and no study has focused on pediatric appendectomy. Likewise, the association between intraoperatively graded event severity and postoperative complication severity graded with the pediatric-specific Clavien-Madadi classification has not been examined in children. This prospective, single-center, single-surgeon, video-based pilot study (IDEAL Framework Stage 2a) evaluates whether ClassIntra can be feasibly applied to the laparoscopic phase of pediatric appendectomy. Eighty children aged 5 to under 18 years undergoing laparoscopic appendectomy for non-complicated acute appendicitis will be enrolled. Operative videos will be recorded, de-identified, assigned a case code, and independently assessed in randomized order by two pediatric surgeons from outside the operating institution, who remain blinded to all postoperative clinical data. Each observed event is characterized on three levels: event type (E1-E7), mechanism (GERT categories M1-M4), and severity (ClassIntra Grade I-V). Postoperative complications within 30 days are graded separately with the Clavien-Madadi classification by the principal investigator, independently of the video assessment. The primary outcome is the feasibility of ClassIntra in this setting, evaluated as a progression-criteria profile rather than a composite rule, using three pre-specified criteria: inter-rater reliability (Gwet's AC1 \>= 0.60, the key indicator), applicable coverage (proportion of non-assessable cases \< 5%), and discriminative capacity (at least three of the five ClassIntra grades represented in the cohort). Secondary outcomes are descriptive: iAE incidence with Wilson score confidence intervals and the distribution of event types, mechanisms and severity grades. Exploratory hypotheses examine the association of intraoperative event severity with adherence to the institutional Enhanced Recovery After Surgery (ERAS) protocol, with time to medical readiness for discharge, and with Clavien-Madadi-graded postoperative complication severity. The study involves no additional intervention, investigational product, or extra procedure for the participating children; care follows institutional standards throughout. Its purpose is to provide feasibility evidence and calibration parameters for subsequent multicenter validation studies, not to establish the validity of the classification system itself.

The Effect of Multisensory Stimulation Administered Before Clinical Encounters at the Pediatric Surgery Outpatient Clinic on Children's Anxiety and Fear Levels and Parental Anxiety

Encounters with healthcare services during childhood, particularly surgical evaluation processes, are a significant source of stress for both children and their parents. The initial evaluation, physical examination, and the prospect of a possible procedure conducted in pediatric surgery outpatient clinics can lead to increased levels of anxiety and fear in children. This situation not only affects the child's current psychological state but also reduces their cooperation during the examination, makes collaboration with healthcare professionals more difficult, and can negatively impact the overall healthcare experience. Increased levels of anxiety and fear in children are not limited to emotional reactions alone; they also affect physiological and behavioral responses, thereby shaping the entire healthcare process. Similarly, parents may also experience significant situational anxiety due to uncertainty about their child's health status, the possibility of surgical intervention, and the responsibility for care. Parental anxiety is a significant factor that can influence children's levels of anxiety and fear and can indirectly shape the child's healthcare experience through parent-child interaction.

Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children

Preoperative anxiety and fear are common among preschool children undergoing surgery and may negatively affect perioperative cooperation and postoperative recovery. This study aims to evaluate the effects of three different operating room transport methods (walking with a parent, stretcher transport, and battery-powered ride-on car transport) on preoperative anxiety and fear levels in preschool children undergoing day surgery. The findings are expected to contribute to the development of child-friendly, non-pharmacological interventions to improve the perioperative experience of children.

Digital Literacy in Caregivers of Pediatric Surgery Patients

The purpose of this study is to describe the digital literacy of caregivers of pediatric surgical patients. The investigators hypothesize that caregivers of minority race, language of care other than English, and low neighborhood opportunity will have lower prevalence of digital literacy.

Mid-transverse Process to Pleura Block in Pediatric Thoracotomy

The aim of this study is to assess the effectiveness of analgesia of US guided MTP block in pediatrics undergoing thoracotomy.

Use of Maltodextrins in the ERAS Preoperative Fasting Protocol in Pediatric Surgery

This monocentric prospective randomized controlled pilot study aims to evaluate the effectiveness of preoperative maltodextrin administration within an Enhanced Recovery After Surgery (ERAS) protocol in pediatric surgical patients. Children aged 3 to 8 years undergoing elective day surgery will be randomized 1:1 to receive either a maltodextrin-containing clear liquid or a non-sugared clear liquid before surgery. The study will assess preoperative anxiety, patient compliance, parental anxiety, oxidative stress markers, postoperative feeding tolerance, and postoperative recovery outcomes.

High-flow Nasal Cannula Oxygenation During Rapid Sequence Induction in Children

This randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children. 170 children aged less then 11 years, admitted to the operating room for surgery and with a medical indication of a RSI of anesthesia will be recruited in one university hospital (Necker-Enfants-Malades in Paris). Children will be randomly assigned into two groups: the control group will benefit of standard care and the HFNO group will receive heated and humidified oxygen through a nasal cannula device during pre-oxygenation and apnoea time prior to tracheal intubation. HFNO has been evaluated and showed benefits in rapid sequence induction of anesthesia in adults and prolonged apnea time before desaturation in children. To the investigators' knowledge the potential benefit of HFNO during RSI in young children remain to be evaluated.

Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial

The objective of the study is to evaluate the benefits on pre-operative anxiety of an information assistance application in addition to a traditional anesthesia consultation on preoperative anxiety in pediatrics

Evaluation of the Effect of Perioperative Recruitment Maneuver Practice on Lung Ultrasound Score and Mechanical Power in Pediatric Patients

Pulmonary atelectasis is common during general anesthesia and increases the risk of hypoxemia, especially in pediatric patients. PEEP and recruitment maneuvers (RM) are effective in preventing atelectasis. Lung ultrasound is practical for diagnosis. Mechanical power refers to the amount of energy delivered to the lung by the ventilator; excessive mechanical power can cause lung injury. Limiting mechanical power may reduce postoperative complications. This study aimed to determine the effectiveness of recruitment maneuvers in preventing atelectasis using lung ultrasound during the intraoperative period, to examine the relationship between lung ultrasound scores and mechanical power, and to demonstrate the effect of recruitment maneuvers on postoperative pulmonary complications. This study is based on the hypothesis that "The recruitment maneuver reduces perioperative atelectasis and the development of related complications, and lung ultrasound can be used to detect this. The lung ultrasound score also decreases in patients with reduced mechanical force." It will be prospectively applied to pediatric patients aged 1-14 years who will undergo surgery in the operating rooms of Cerrahpaşa Medical Faculty. Patients included in the study will be prospectively randomized into 3 groups. The randomization performed using the sealed opaque envelope method.All patients will be ventilated in VG-Pressure guaranteed mode. Tidal volume will be calculated as 6-8 ml/kg of ideal body weight. GROUP 1: Fixed PEEP: 5 cmH2O, GROUP 2: PEEP: 5 cmH2O, 5 cycles, recruitment maneuver with plateau P\<35 cm H2O and vital capacity x2. GROUP 3: PEEP: 5 cmH2O, 5 cycles of recruitment maneuvers will be performed in the right and left lateral decubitus position before extubation with P\<35 cmH2O and vital capacity x2. Lung ultrasound will be performed before induction (1), 5 minutes after intubation (2), before extubation (3), and finally 5 minutes after extubation(4). Each hemithorax will be divided into 6 regions, and lung scores will be recorded. At 5 minutes after intubation and every hour there after, PeakP, PlateauP, DeltaP, Compliance, Driving Pressures, and Mechanical Work calculations will be recorded before and after the maneuver in the group undergoing the recruitment maneuver.

Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal

This randomized controlled trial compares purse-string versus conventional linear skin closure techniques in children undergoing stoma reversal surgery. The primary aim is to assess surgical site infection rates within 30 days and scar cosmesis at 3 months using the Manchester Scar Scale. Fifty patients (25 per group) will be randomized at Assiut University Pediatric Surgery Department to determine if purse-string closure reduces infections and improves scarring.

Management of Pediatric Pancreatic Calculi At a Single Center: a Retrospective Cohort Study

The goal of this observational study is to evaluate the long-term effects of ERCP and surgery in pediatric patients with pancreatic duct stones. The main objective is to determine the optimal treatment choice(ERCP or surgery) for children with pancreatic duct stones and identify the appropriate timing for surgery in patients who have undergone multiple ERCP procedures, in order to avoid adverse outcomes caused by repeated trauma to the duodenal papilla. Last updated on January 24, 2025.