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
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.
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
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
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
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
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.
Pediatric Central Nervous System Tumor
Study of Tozuleristide and the Canvas Imaging System in Pediatric Subjects With CNS Tumors Undergoing Surgery
Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed.
- Trial name
- NCT03579602
- Testing
- tozuleristide, Canvas System
- Where
- 9 sites in United States
- Volunteers
- 118 people
- Sponsor
- Blaze Bioscience 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
Hypovolemia
Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major…
- Trial name
- NCT01531803
- Testing
- Kedbumin 25%, Normal Saline Solution
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kedrion S.p.A.
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
Liver Surgery, Liver Dysfunction
Octaplas Pediatric Plasma Replacement Trial
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors.
- Conditions
- Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
- Trial name
- NCT02050841
- Testing
- octaplas
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Octapharma
Cataract
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
- Trial name
- NCT01475643
- Testing
- Loteprednol etabonate, Prednisolones acetate
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Bausch & Lomb Incorporated
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
Acute Pain
A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age < 2 years) compared to placebo…
- Trial name
- NCT01635101
- Testing
- IV Acetaminophen, IV Control
- Where
- 22 sites in United States
- Volunteers
- 197 people
- Sponsor
- Mallinckrodt
Post-Operative Pain, Acute Pain
Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.
- Trial name
- NCT02687451
- Testing
- Oxymorphone HCl
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Postoperative Nausea and Vomiting
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic…
- Trial name
- NCT00819039
- Testing
- Aprepitant, Ondansetron
- Where
- 6 sites in United States, Brazil and 3 more
- Volunteers
- 98 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Pediatric Perioperative Blood Pressure Management
Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
Evaluate the efficacy, safety, and dosing of clevidipine as an intravenous (IV) infusion for blood pressure (BP) management in paediatric participants in the perioperative setting.
- Trial name
- PIONEER (NCT01938547)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.