Clinical trials: Pediatric Sedation
ICU Sedation
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor
- Trial name
- Pedrux (NCT03813277)
- Testing
- Dexmedetomidine
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Orion Corporation, Orion Pharma
Operative Sedation of Pediatric, Operative Sedation of Adolescent Patients
A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
- Trial name
- NCT07036419
- Testing
- Remimazolam Tosilate for injection, Propofol Injection
- Where
- China
- Volunteers
- 249 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Sedation
Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects.
- Trial name
- NCT00875550
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 37 sites in United States, Canada
- Volunteers
- 175 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
MRI Sedation
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to <17 years of age undergoing…
- Trial name
- NCT04237792
- Testing
- dexmedetomidine, propofol
- Where
- 23 sites in United States, Japan
- Volunteers
- 128 people
- Sponsor
- Pfizer
Ultrasound, CT Scans
Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic…
- Conditions
- Ultrasound, CT Scans, MRIs
- Trial name
- NCT01519167
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 91 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation
A Study to Learn About the Study Medicine - Precedex in Children From Japan.
The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.
- Trial name
- NCT06085573
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer
Sedation
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device (ACD)) versus intravenous midazolam for sedation in mechanically ventilated children admitted to an…
- Trial name
- IsoCOMFORT (NCT04684238)
- Testing
- Midazolam, Isoflurane
- Where
- 24 sites in France, Germany and 3 more
- Volunteers
- 94 people
- Sponsor
- Sedana Medical
Anesthesia
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.
- Trial name
- NCT03128931
- Testing
- Pediatric SedLine forehead EEG sensor
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Masimo Corporation
ICU Sedation
Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit
To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years old] requiring sedation under intensive care…
- Trial name
- NCT02757625
- Testing
- Dexmedetomidine hydrochloride
- Where
- 12 sites in Japan
- Volunteers
- 63 people
- Sponsor
- Pfizer
Pediatric ALL
Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures
- Trial name
- NCT04851717
- Testing
- Remimazolam
- Where
- 8 sites in United States, Denmark
- Volunteers
- 100 people
- Sponsor
- Acacia Pharma Ltd
Sedation
Precedex Special Investigation (in Pediatric Patients)
Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.
- Trial name
- NCT04040439
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer
Critical Illness
Lorazepam Sedation for Critically Ill Children
This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs.
- Trial name
- NCT00109395
- Testing
- Lorazepam, Midazolam, Lorazepam CI
- Where
- United States
- Volunteers
- 179 people
- Sponsor
- The Emmes Company, LLC
Sedation, Pain
Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months
The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through <24 months, administered as an intravenous…
- Trial name
- NCT01378988
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer