NCT01519167

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2012

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 14, 2015

Completed
Last Updated

March 20, 2017

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

January 24, 2012

Results QC Date

May 5, 2015

Last Update Submit

March 16, 2017

Conditions

UltrasoundCT ScansMRIs

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Who Had Success in Sedation

    Success in sedation was defined by a combined endpoint which was the combination of the following: 1. Subject had adequate level of sedation (University of Michigan Sedation Scale \[UMSS\] score between 1 to 3 \[minimally sedated to deeply sedated\] or Neonatal Pain, Agitation and Sedation Scale \[N-PASS\] score between -5 to -2 \[Light sedation\]) at least 80% of the time the subject was given the study drug. 2. Subject had successfully completed the procedure without a need for rescue sedation (Midazolam). 3. Subject had undergone the procedure without artificial ventilation or intervention to restore baseline or normal hemodynamic status

    From baseline to end of post-treatment period (approximately 24 hours)

Secondary Outcomes (9)

  • Number of Subjects Not Receiving Rescue Midazolam

    During the treatment period, up to approximately 24 hours

  • Number of Subjects Who Have Undergone Procedures Without Artificial Ventilation or Intervention

    During the treatment period, up to approximately 24 hours

  • Number of Subjects Who Were Adequately Sedated at Least 80% of Time

    During the treatment period, up to approximately 24 hours

  • Time to First Dose of Rescue Midazolam From Start of Dexmedetomidine Infusion

    During the treatment period, up to approximately 24 hours

  • Frequency of Midazolam Required for Sedation

    During the treatment period, up to approximately 24 hours

  • +4 more secondary outcomes

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL
Drug: DexmedetomidineDrug: MidazolamDrug: Fentanyl

Interventions

DexmedetomidineDRUG

0.1 - 1.0 mcg/kg/hr IV

Dexmedetomidine
MidazolamDRUG

0.025 - 2 mg/kg IV

Dexmedetomidine
FentanylDRUG

0.5 - 3 mcg/kg IV

Dexmedetomidine

Eligibility Criteria

Age28 Weeks - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.)
  • Subject is American Society of Anesthesiologists (ASA) Physical Status I, II or III.
  • 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.
  • 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).
  • Duration of the procedure is expected to take at least 30 minutes to complete.
  • If female, subject is non-lactating and is either:
  • Not of childbearing potential, defined as pre-menarche, or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
  • Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
  • Subject's parent(s) or legally acceptable representative(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board. Assent will be obtained where age-appropriate and according to state regulations.

You may not qualify if:

  • Subjects weight at the time of screening is less than 1000 g.
  • 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 dexmedetomidine within 48 hours prior to study drug administration.
  • Subject that has been previously enrolled in this study (DEX-10-16).
  • 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. Examples include, but are not limited to the following: cerebral palsy, autism, severe mental retardation, etc.
  • 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.
  • Subject has a known allergy to dexmedetomidine, 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, dexmedetomidine or other alpha-2 agonists are contraindicated.
  • Subject has received an IV opioid within one hour, or oral/intramuscular (PO/IM) opioid within four hours, prior to the start of study drug administration.
  • Subject has received any pre-induction medication (ie, ketamine, chloral hydrate, benzodiazepines) within 4 hours prior to the start of study drug administration.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Little Rock, Arkansas, 72202, United States

Location

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Stanford, California, 94305, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15224, United States

Location

Unknown Facility

Nashville, Tennessee, 37232-9070, United States

Location

Unknown Facility

Dallas, Texas, 75235, United States

Location

Unknown Facility

Sandy City, Utah, 84096, United States

Location

Unknown Facility

San Juan, 00936-5067, Puerto Rico

Location

Unknown Facility

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Interventions

DexmedetomidineMidazolamFentanyl

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperidines

Results Point of Contact

Title
Marcelo Garcia de Rocha MD, Global Medical Director
Organization
Hospira
marcelo.rocha@hospira.com
224-212-4424

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 26, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 20, 2017

Results First Posted

August 14, 2015

Record last verified: 2015-08

Locations

PR(2)US(9)