Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
This study is currently recruiting participants.
Verified August 2013 by Hospira, Inc.
Information provided by (Responsible Party):
First received: January 24, 2012
Last updated: August 2, 2013
Last verified: August 2013
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
Primary Outcome Measures:
- Treatment Emergent Adverse Events [ Time Frame: 24 hours after discontinuation of study drug ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
0.2 - 1.0 mcg/kg/hr IV
0.025 - 2 mg/kg IV
0.5 - 3 mcg/kg IV
This study was designed to evaluate the safety of a continuous infusion of DEX (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.
|Ages Eligible for Study:
||1 Year to 16 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subject is ≥ 1 year and <17 years of age.
- Subject is American Society of Anesthesiologists (ASA) Physical Status I or II.
- Subject requires non-intubated, spontaneous breathing, moderate to deep sedation, (NI-MDS) in an operating or procedure room with an anesthesiologist or dental anesthesiologist in attendance.
Scheduled for an elective procedure that falls into one of the following three populations:
- Non-invasive diagnostic procedures
- Minimally invasive diagnostic/therapeutic procedures
- Surgical procedures: including small surgical procedures
4. Duration of the procedure is expected to take > 30 minutes to complete.
5. If female, subject is non-lactating and is either:
- Not of childbearing potential or,
- Of childbearing potential but is not pregnant at time of baseline and is practicing of birth control
- Subject weight at the time of screening is less than 10 kg.
- Subject has received general anesthesia within 7 days prior to study drug administration.
- Subject has participated in an experimental/investigational drug study within 30 days prior to study drug administration.
- Subject has been exposed to DEX within 14 days prior to study drug administration.
- Subject requires endotracheal intubation or laryngeal mask airway (LMA).
- Subject is with neurological conditions that in the opinion of the Investigator will preclude reliable assessment of sedation scoring.
- 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.
- Subject requires epidural or spinal anesthesia.
- Subject has received treatment with an alpha-2 agonist or antagonist within 14 days prior to study drug administration (see Appendix D).
- Subject has a known allergy to DEX, midazolam or fentanyl.
- Subject is requiring cardiac catheterization for the purpose of conducting an electrophysiology (EP) evaluation or percutaneous intervention (i.e. angioplasty).
- Subject for whom opiates, benzodiazepines, DEX or other alpha-2 agonists are contraindicated.
- Subject has received an IV opioid within one hour, or PO/IM opioid within four hours, prior to the start of study drug administration.
- Subject has received any pre-induction medication within 4 hours prior to the start of study drug administration.
- Subject has acute myocardial infarction recently diagnosed by confirmatory laboratory findings within 6 weeks of screening.
- Subject has moderate to severe Sleep Apnea Syndrome.
- Subject has oxygen saturation (SpO2) ≤ 90 % at screening or baseline, except for patients with known cyanotic heart disease undergoing cardiac catheterization.
- Subject has bradycardia immediately before dosing, according to respective age group
- Subject has hypotension immediately before dosing, according to respective age group
- Subject has a presence of second-degree or third-degree heart block at screening or baseline.
- Subject has acute febrile illness, with a temperature (core or tympanic) ≥ 38.0°C.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519167
|Little Rock, Arkansas, United States, 72202 |
|Stanford, California, United States, 94305 |
|Miami, Florida, United States, 33136 |
|Durham, North Carolina, United States, 27710 |
|Pittsburgh, Pennsylvania, United States, 15224 |
|Dallas, Texas, United States, 75235 |
|San Juan, Puerto Rico, 00935 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 24, 2012
||August 2, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Central Nervous System Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists