Clinical trials: Pediatric Surgery
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
Cardiac Surgery, Cardiopulmonary Bypass
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.
- Trial name
- COLCHIRCARD (NCT02584868)
- Testing
- Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution, Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
- Where
- Belgium
- Volunteers
- 88 people
- Sponsor
- Queen Fabiola Children's University Hospital
Respiratory Complications, Pediatric
Evaluation of Respiratory Acoustic Monitor in Children After Surgery
The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).
- Trial name
- NCT02256384
- Testing
- Respiratory Acoustic Monitor
- Where
- 2 sites in United States
- Volunteers
- 76 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Strabismus, Delirium on Emergence
Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.
- Conditions
- Strabismus, Delirium on Emergence, Pediatric Disorders
- Trial name
- NCT01901588
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- NYU Langone Health
Intubation, Intratracheal
Comparison of Miller's Blade and Airtraq Laryngoscope in Children
The Airtraq optical laryngoscope has recently been available in pediatric sizes. The investigators compared the efficacy of Airtraq with the Miller laryngoscope as intubation devices in paediatric patients.
- Trial name
- NCT02423317
- Testing
- Intubation with Miller's blade, Intubation with Airtraq
- Volunteers
- 60 people
- Sponsor
- Government Medical College, Haldwani
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Malignant Melanoma
BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations
This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric…
- Trial name
- NCT01519323
- Testing
- vemurafenib
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 6 people
- Sponsor
- Hoffmann-La Roche
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
Low T3 Syndrome
Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children?
Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill. This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary bypass.
- Trial name
- NCT01780584
- Testing
- Oral T3 Low dose, Oral T3 high dose
- Where
- Indonesia
- Volunteers
- 45 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Cataracts, Inflammation
Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.
- Trial name
- NCT01124045
- Testing
- Difluprednate ophthalmic emulsion, 0.05%, Prednisolone acetate ophthalmic suspension, 1.0%
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Alcon Research
Obstruction of Pelviureteric Junction
The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
The investigators propose a prospective blinded randomized control trial (RCT) to assess the efficacy and safety of a simple method of continuous infusion of a local anesthetic, ropivacaine, via a surgical wound to control pain…
- Trial name
- NCT00930046
- Testing
- Ropivacaine wound catheter, Saline wound catheter
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Boston Children's Hospital
Childhood Craniopharyngioma
Peginterferon Alfa-2b in Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
This phase II trial studies how well peginterferon alfa-2b works in treating younger patients with craniopharyngioma that is recurrent or cannot be removed by surgery.
- Trial name
- NCT01964300
- Testing
- peginterferon alfa-2b, laboratory biomarker analysis
- Where
- 9 sites in United States
- Volunteers
- 19 people
- Sponsor
- Pediatric Brain Tumor Consortium
Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery
IV Lidocaine in Pediatric AIS
This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid…
- Trial name
- PEDS LIDO (NCT03893318)
- Testing
- IV lidocaine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Washington University School of Medicine
Anesthesia, Child
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery…
- Trial name
- NCT02240368
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- University of Foggia
Surgical Site Infection, Vancomycin
Pharmacokinetics of Preoperative Vancomycin
A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.
- Trial name
- NCT03453684
- Testing
- Administration of Vancomycin
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Colorado, Denver
Surgical Bleeding
Topical Raplixa for Surgical Bleeding in Children
The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone in stopping mild to moderate bleeding in children having surgery.
- Trial name
- NCT02117349
- Testing
- Raplixa, Gelfoam, Rescue treatment
- Where
- 13 sites in United States
- Volunteers
- 55 people
- Sponsor
- Mallinckrodt
Congenital Heart Diseases, Aortic Valve Disorder
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
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…
- Trial name
- NCT01619982
- Testing
- Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride, Cefazolin 30 mg/kg body weight
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Stanford University
Cheilitis, Angular, Postoperative Complications
Using Dexpanthenol Cream to Prevent Lip Corner Cracks in Children After Tonsil/Adenoid Surgery
Soreness and cracking at the corners of the mouth, a condition called angular cheilitis, can be an uncomfortable problem for children after they have surgery to remove their tonsils and adenoids.
- Conditions
- Cheilitis, Angular, Postoperative Complications, Adenotonsillar Hypertrophy
- Trial name
- PrevAC-PedAT (NCT07002632)
- Testing
- Dexpanthenol 5 % Topical Ointment
- Where
- Turkey (Türkiye)
- Volunteers
- 106 people
- Sponsor
- Gaziosmanpasa Research and Education Hospital
Obesity, DM
Lap-Band Surgery on Adolescents for Safety and Efficacy
This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.
- Trial name
- ALAGB (NCT00587301)
- Testing
- Lap-Band
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- NYU Langone Health
Obesity, Adolescent, Bariatric Surgery Candidate
Lifestyle Improvement for Teens With Bariatric Surgery
This study aims to conduct a proof-of-concept study to assess the feasibility, acceptability, and effectiveness of a Metabolic and bariatric surgery (MBS) -supported healthy lifestyle behavioral intervention among adolescent…
- Trial name
- LIFT (NCT05393570)
- Testing
- Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston