Clinical trials: Pediatric Surgery
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Fractures, Bone, Impending Fracture
Retrospective Study on Clinical Performance and Safety Profile of Agile Nail
This study aims to retrospectively collect data from routine clinical practice in order to evaluate the safety profile of the Agile intramedullary nail, used in pediatric patients according to the manufacturer Instructions For…
- Conditions
- Fractures, Bone, Impending Fracture, Deformity; Bone
- Trial name
- Agile (NCT06412939)
- Testing
- Agile Nail
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Orthofix s.r.l.
General Anesthetic
HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery
This multicenter, randomized, double-blinded, propofol-controlled Phase 3b study enrolls pediatric subjects aged 3-17 years undergoing elective surgery with endotracheal intubation.
- Trial name
- NCT07510945
- Testing
- HSK3486, propofol
- Volunteers
- 400 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
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
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
Otitis Media With Effusion in Children, Otitis Media Recurrent
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
- Trial name
- NCT02539654
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Alcon Research
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH
Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and…
- Conditions
- Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures, Adult Gastric Procedures
- Trial name
- NCT05039021
- Testing
- HARMONIC 1100 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 265 people
- Sponsor
- Ethicon Endo-Surgery
Otitis Media
Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery
The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.
- Trial name
- NCT01908764
- Testing
- AL-60371 otic suspension
- Sponsor
- Alcon Research
Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery
The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery.
- Trial name
- NCT01127477
- Testing
- 1: Hydroxyethyl starch 130/0.4, 6 %
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Fresenius Kabi Japan
Acute Lung Injury
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
- Trial name
- NCT02891837
- Testing
- L-citrulline
- Where
- 29 sites in United States, Austria and 2 more
- Volunteers
- 189 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Postoperative Pain
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs.
- Trial name
- NCT06271265
- Testing
- EXPAREL, bupivacaine
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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.
Cataract
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
- Trial name
- NCT05191706
- Testing
- Dexamethasone, Prednisolone Acetate Ophthalmic
- Where
- 9 sites in United States
- Volunteers
- 17 people
- Sponsor
- EyePoint Pharmaceuticals, Inc.
Post Operative Pain
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain in pediatric subjects.
- Trial name
- NCT01210352
- Testing
- oxymorphone HCl
- Where
- 8 sites in United States
- Volunteers
- 61 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Pain, Postoperative
Study of Indomethacin 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 indomethacin capsules low dose and high dose in children ages 6 to <17 years experiencing mild to…
- Trial name
- NCT02633969
- Testing
- Indomethacin Capsules low dose, Indomethacin Capsules high dose
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Iroko Pharmaceuticals, LLC
Pediatric Cancer, Surgery
A Pilot Randomized Controlled Trial for Feasibility of Administering an AR Game to Postoperative Pediatric Cancer Patients
This is a pilot study to evaluate the feasibility of SpellBound's AR (augmented reality)-enabled scavenger hunt use among 20 pediatric cancer patients undergoing surgery.
- Trial name
- GAMING (NCT04674150)
- Testing
- ARISE with AR, ARISE without AR
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- ALTality, Inc.
Local Analgesia Via Infiltration
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.
- Trial name
- NCT06344091
- Testing
- Bupivacaine Liposome Injection
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Hernia, Inguinal, Flat Foot
The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial to evaluate the efficacy and safety of local anesthetic Chloroprocaine at two different concentrations ( at 1% and 2%) in a pediatric…
- Trial name
- NCT03918798
- Testing
- Chloroprocaine 1% Injectable Solution, Chloroprocaine 2% Injectable Solution
- Where
- 9 sites in Italy, Spain
- Volunteers
- 164 people
- Sponsor
- Sintetica SA