Clinical trials: Pediatric Pain
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Chronic Pain
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours.
- Trial name
- NCT00765856
- Testing
- Oxymorphone ER
- Where
- 13 sites in United States
- Volunteers
- 27 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Pain
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant…
- Trial name
- NCT01192295
- Testing
- Oxycodone HCl controlled-release tablets
- Where
- 47 sites in United States, Greece and 6 more
- Volunteers
- 155 people
- Sponsor
- Purdue Pharma LP
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
Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.
- Trial name
- NCT01982539
- Testing
- Zipsor®
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Depomed
Sickle Cell Disease
Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease
The purpose of the study is to Evaluate the Effect of Ticagrelor versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients with Sickle Cell Disease
- Trial name
- HESTIA3 (NCT03615924)
- Testing
- Ticagrelor
- Where
- 55 sites in United States, Belgium and 14 more
- Volunteers
- 193 people
- Sponsor
- AstraZeneca
Burns
Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours…
- Trial name
- NCT00606489
- Testing
- Caldolor
- Where
- 5 sites in United States, India
- Volunteers
- 61 people
- Sponsor
- Cumberland Pharmaceuticals
Chronic Pain
Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic…
- Trial name
- NCT02321319
- Testing
- Hydromorphone HCl ER Tablets
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Mallinckrodt
Enthesitis Related Arthritis (ERA)
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA).
- Trial name
- NCT01166282
- Testing
- adalimumab
- Volunteers
- 46 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Postoperative Pain Management
Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
Primary Objective: To evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.
- Trial name
- PLAY (NCT03682302)
- Testing
- Exparel, 0.5% Bupivacaine HCl
- Where
- 17 sites in United States
- Volunteers
- 98 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Pain, Postoperative
Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.
- Trial name
- NCT02395653
- Testing
- fentanyl
- Where
- 10 sites in United States
- Volunteers
- 71 people
- Sponsor
- The Medicines Company
Athletic Injuries
Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.
- Trial name
- NCT02132247
- Testing
- Diclofenac hydroxyethylpyrrolidine
- Where
- 10 sites in United States
- Volunteers
- 104 people
- Sponsor
- IBSA Institut Biochimique SA
Pain, Fever
Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients
We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults.
- Trial name
- NCT00493246
- Testing
- IV Acetaminophen
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Mallinckrodt
Postoperative Pain
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal…
- Trial name
- NCT00801398
- Testing
- Oxymorphone IR
- Where
- 11 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Moderate-severe Pain
Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain
Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
- Trial name
- NCT02101554
- Testing
- Ages 7-11, ages 12-17
- Where
- 19 sites in United States
- Volunteers
- 19 people
- Sponsor
- Pfizer
Pain
Evaluate The Pharmacokinetics and Safety Of Oxycodone Oral Solution In Pediatric and Adolescent Subjects
The objective of this study is to characterize the pharmacokinetics and to evaluate the safety of single and multiple doses of Oxycodone Oral Solution in pediatric and adolescent subjects for postoperative pain.
- Trial name
- NCT01959204
- Testing
- Oxycodone
- Where
- 9 sites in United States
- Volunteers
- 97 people
- Sponsor
- VistaPharm, Inc.
Unilateral Cataract Extraction, Congenital Cataract
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in…
- Trial name
- ILR7 (NCT02132312)
- Testing
- OMS302, Phenylephrine HCl
- Where
- 11 sites in United States
- Volunteers
- 78 people
- Sponsor
- Omeros Corporation
Pain
Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients
The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting.
- Trial name
- NCT06364072
- Testing
- CT001
- Where
- 7 sites in Spain, United Kingdom
- Volunteers
- 155 people
- Sponsor
- Cessatech A/S
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
Systemic Juvenile Idiopathic Arthritis (SJIA)
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.
- Trial name
- ß-SPECIFIC 4 (NCT02296424)
- Testing
- ACZ885 150 mg (Canakinumab)
- Where
- 50 sites in United States, Austria and 14 more
- Volunteers
- 182 people
- Sponsor
- Novartis Pharmaceuticals