Clinical trials: Pediatric Sedation
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
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
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
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
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
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
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