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COMPLETEDPHASE4

Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation

NCT01519167•Hospira, now a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

Summary

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 procedures, expected to take more than 30 minutes.

Detailed Description

This study was designed to evaluate the safety of a continuous infusion of dexmedetomidine (1 mcg/kg loading dose with 0.6 mcg/kg/hr initial maintenance dose and titrated between 0.2-1.0 mcg/kg/hr) administered to subjects requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic procedures that are expected to take more than 30 minutes.

Eligibility

Age

0 - 16 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is ≥28 weeks gestational age and \<17 years of age.
•\- Preterm subjects ≥28 weeks through \<38 weeks, gestational age; (Note: Gestational age will be calculated as the time elapsed between the first day of the last menstrual period to the day of enrollment. If pregnancy was achieved using assisted reproductive technology, gestational age will be calculated by adding 2 weeks to the gestational age as calculated above.)
•2. Subject is American Society of Anesthesiologists (ASA) Physical Status I, II or III.
•3. Subject requires non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) in an operating or procedure room with an an intensivist, anesthesiologist or dental anesthesiologist in attendance.
•4. Scheduled for an elective procedure that falls into one of the following three populations:
•* Non-invasive diagnostic/therapeutic procedures (NIDTP): including ultrasound (US), computed tomography (CT) scans, magnetic resonance imaging (MRI), cardiac catheterization, transthoracic echocardiogram (TTE);
•* Minimally invasive diagnostic/therapeutic procedures (MIDTP): including minimally invasive procedures performed under US or CT guidance (e.g. US or CT-guided solid organ biopsy), and routine myocardial biopsies in cardiac transplant recipients;
•* Surgical procedures: including small surgical procedures (e.g. excisions, biopsies) and dental procedures (e.g. extractions, pulpectomy, pediatric rehabilitation dental procedures, filings and crowns).
•5. Duration of the procedure is expected to take at least 30 minutes to complete.
•6. If female, subject is non-lactating and is either:
+3 more criteria

Exclusion Criteria

•1. Subjects weight at the time of screening is less than 1000 g.
•2. Subject has received general anesthesia within 7 days prior to study drug administration.
•3. Subject has participated in an experimental/investigational drug study within 30 days prior to study drug administration.
•4. Subject has been exposed to dexmedetomidine within 48 hours prior to study drug administration.
•5. Subject that has been previously enrolled in this study (DEX-10-16).
•6. Subject requires endotracheal intubation or laryngeal mask airway (LMA).
•7. Subject is with neurological conditions that in the opinion of the Investigator will preclude reliable assessment of sedation scoring. Examples include, but are not limited to the following: cerebral palsy, autism, severe mental retardation, etc.
•8. Subject has central nervous system (CNS) disease with an anticipated potential for increased intracranial pressure, an uncontrolled seizure disorder and/or known psychiatric illness that could confound a normal response to sedative treatment.
•9. Subject requires epidural or spinal anesthesia.
•10. Subject has received treatment with an alpha-2 agonist or antagonist within 14 days prior to study drug administration.
+27 more criteria

Locations (11)

Little Rock, Arkansas, United States

Anaheim, California, United States

Stanford, California, United States

Miami, Florida, United States

Durham, North Carolina, United States

Pittsburgh, Pennsylvania, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Sandy City, Utah, United States

San Juan, Puerto Rico

Key Dates

Start Date

October 1, 2012

Primary Completion Date

January 1, 2014

Completion Date

January 1, 2014

Last Updated

March 20, 2017

Enrollment

ACTUAL participants

Conditions

UltrasoundCT ScansMRIs

Interventions

Dexmedetomidine

DRUG

Midazolam

DRUG

Fentanyl

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation

Inclusion Criteria

Exclusion Criteria

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