Clinical trials: Pediatric Surgery
Single Ventricle
Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
The purpose of this study is to test the efficacy of treprostinil (TRE) in the perioperative non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube drainage (in days).
- Trial name
- NCT02498444
- Testing
- Treprostinil
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Stanford University
Pain, Postoperative
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to <17 years experiencing mild to…
- Trial name
- NCT02424578
- Testing
- Diclofenac Capsules low dose, Diclofenac Capsules high dose
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Iroko Pharmaceuticals, LLC
Penicillin Allergy
Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients
The proposed research project will retrospectively review the anesthetic records over the past 5 years and identify patients who present with a history of penicillin allergy or allergy to an antibiotic in the penicillin family.
- Trial name
- NCT02036840
- Testing
- Antibiotic
- Where
- United States
- Volunteers
- 513 people
- Sponsor
- Joseph D. Tobias
Congenital Heart Defect, Surgery-Induced Tissue Adhesions
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and…
- Conditions
- Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
- Trial name
- NCT01330433
- Testing
- CoSeal Surgical Spray Group
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Loma Linda University
Postoperative Infection
Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects
This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery.
- Trial name
- NCT03231228
- Testing
- Cefazolin 1 g Infusion, Cefazolin 2 g Infusion
- Where
- 5 sites in United States
- Volunteers
- 61 people
- Sponsor
- B. Braun Medical Inc.
Inflammatory Bowel Disease, Crohn's Disease
ENhanced Recovery in CHildren Undergoing Surgery
The institution of perioperative Enhanced Recovery Protocols (ERPs) has been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but data in pediatric populations are…
- Conditions
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- Trial name
- ENRICH-US (NCT04060303)
- Testing
- Perioperative surgical care
- Where
- United States
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
iotaSOFT Pediatric Study
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Trial name
- NCT06106373
- Testing
- iotaSOFT Insertion System
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- iotaMotion, Inc.
Post Operative Pain
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to <17 years.
- Trial name
- NCT05315479
- Testing
- N1539
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Baudax Bio
Cleft Palate
Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair
The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects.
- Trial name
- NCT01500109
- Testing
- Oral acetaminophen, Ofirmev®, Opioid only
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Loma Linda University
Spinal Fusion, Cardiopulmonary Bypass
Point of Care Testing in Pediatric Patients Undergoing Major Surgery
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).
- Trial name
- NCT01742936
- Testing
- CoaguChek, Hospital Laboratory
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Nationwide Children's Hospital
Adenotonsillectomy, Analgesia
Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity
The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups.
- Conditions
- Adenotonsillectomy, Analgesia, Surgery
- Trial name
- NCT04879823
- Testing
- Dexamethasone, Ibuprofen, Acetaminophen
- Where
- 2 sites in United States
- Volunteers
- 222 people
- Sponsor
- David Chi, MD
Congenital Heart Defect
Erythropoietin and Pediatric Cardiac Surgery
Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may…
- Trial name
- EPO (NCT00451698)
- Testing
- acyanotic erythropoietin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Medical College of Wisconsin
Congenital Heart Disease
Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
The investigators hypothesize that intermittent bolus doses of morphine and midazolam can provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus infusions while using smaller total doses of both…
- Trial name
- NCT02112448
- Testing
- continuous infusion, as needed dosing, Acetaminophen
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Wake Forest University Health Sciences
Pediatric Cardiac Surgery, Intraoperative Awareness
Closed Loop Propofol Administration in Pediatric Cardiac Surgery
The purpose of the study is to evaluate and compare the feasibility, efficacy and safety of IAADS (Improved Anaesthetic Agent Delivery System) for propofol anaesthesia against manual control using bispectral index in paediatric…
- Conditions
- Pediatric Cardiac Surgery, Intraoperative Awareness, Automated Drug Delivery
- Trial name
- NCT01600287
- Testing
- IAADS, Manual propofol administration
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Ambulatory Surgery
REducing Anxiety in CHildren Undergoing Procedures
This is a small pilot, feasibility study designed as a quality improvement project. The purpose is to identify anxiety in children aged 4-12 years who will receive a sedated procedure and to see if the use of an iPad as a focused…
- Trial name
- REACH-UP! (NCT03054077)
- Testing
- iPad with downloaded games
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Virginia Commonwealth University
Cerebral Palsy, Hip Dysplasia
Peri-operative Use of a Pain Injection in Pediatric Patients With Cerebral Palsy
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly.
- Conditions
- Cerebral Palsy, Hip Dysplasia, Pain, Postoperative
- Trial name
- NCT04074265
- Testing
- Ropivacaine injection, normal saline
- Where
- 4 sites in United States
- Volunteers
- 34 people
- Sponsor
- University of California, Los Angeles
Pediatric Congenital Heart Surgery
Predictive Value of the FORE-SIGHT™ Monitor for Hemodynamic Deterioration
The postoperative period after congenital heart surgery in children can be a very critical episode, where it is of utmost importance to closely monitor the circulation in these patients.
- Trial name
- NCT01706497
- Testing
- Cerebral tissue oxygen saturation monitoring, blinded
- Where
- Belgium
- Volunteers
- 300 people
- Sponsor
- KU Leuven
Post-Operative Nausea and Vomiting
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children.
- Trial name
- NCT00231478
- Testing
- granisetron
- Where
- 11 sites in United States
- Volunteers
- 171 people
- Sponsor
- Hoffmann-La Roche
Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD)
Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Cardiac surgery induces a measurable stress response in patients which leads to increased morbidity and mortality post-operatively.
- Conditions
- Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD), Atrioventricular Septal Defects (AVSD)
- Trial name
- NCT00848393
- Testing
- Fentanyl (High Dose), Fentanyl (Low Dose), Fentanyl (Low Dose) + Dexmedetomidine
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Nationwide Children's Hospital
Congenital Heart Disease
Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs.
- Trial name
- NCT00850720
- Testing
- Blood draws
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Emory University