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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01519167
First received: January 24, 2012
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Ultrasound
CT Scans
MRIs
Drug: Dexmedetomidine
Drug: Midazolam
Drug: Fentanyl
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Treatment Emergent Adverse Events [ Time Frame: 24 hours after discontinuation of study drug ] [ Designated as safety issue: Yes ]

Enrollment: 91
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine Drug: Dexmedetomidine
0.2 - 1.0 mcg/kg/hr IV
Drug: Midazolam
0.025 - 2 mg/kg IV
Drug: Fentanyl
0.5 - 3 mcg/kg IV

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is ≥ 1 year and <17 years of age.
  2. Subject is American Society of Anesthesiologists (ASA) Physical Status I or II.
  3. 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.
  4. 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:

  1. Not of childbearing potential or,
  2. Of childbearing potential but is not pregnant at time of baseline and is practicing of birth control

Exclusion Criteria:

  1. Subject weight at the time of screening is less than 10 kg.
  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 DEX within 14 days prior to study drug administration.
  5. Subject requires endotracheal intubation or laryngeal mask airway (LMA).
  6. Subject is with neurological conditions that in the opinion of the Investigator will preclude reliable assessment of sedation scoring.
  7. 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.
  8. Subject requires epidural or spinal anesthesia.
  9. Subject has received treatment with an alpha-2 agonist or antagonist within 14 days prior to study drug administration (see Appendix D).
  10. Subject has a known allergy to DEX, midazolam or fentanyl.
  11. Subject is requiring cardiac catheterization for the purpose of conducting an electrophysiology (EP) evaluation or percutaneous intervention (i.e. angioplasty).
  12. Subject for whom opiates, benzodiazepines, DEX or other alpha-2 agonists are contraindicated.
  13. Subject has received an IV opioid within one hour, or PO/IM opioid within four hours, prior to the start of study drug administration.
  14. Subject has received any pre-induction medication within 4 hours prior to the start of study drug administration.
  15. Subject has acute myocardial infarction recently diagnosed by confirmatory laboratory findings within 6 weeks of screening.
  16. Subject has moderate to severe Sleep Apnea Syndrome.
  17. Subject has oxygen saturation (SpO2) ≤ 90 % at screening or baseline, except for patients with known cyanotic heart disease undergoing cardiac catheterization.
  18. Subject has bradycardia immediately before dosing, according to respective age group
  19. Subject has hypotension immediately before dosing, according to respective age group
  20. Subject has a presence of second-degree or third-degree heart block at screening or baseline.
  21. Subject has acute febrile illness, with a temperature (core or tympanic) ≥ 38.0°C.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519167

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, California
Stanford, California, United States, 94305
United States, Florida
Miami, Florida, United States, 33136
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Dallas, Texas, United States, 75235
Puerto Rico
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01519167     History of Changes
Other Study ID Numbers: DEX-10-16
Study First Received: January 24, 2012
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Midazolam
Fentanyl
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on August 27, 2014