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UltrasoundPhase 4NCT01519167

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

A Phase 4 study testing Dexmedetomidine, Midazolam and Fentanyl in people with Ultrasound and CT Scans, run by Hospira, now a wholly owned subsidiary of Pfizer at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 28 weeks to 16 years
Conditions the study is for
Ultrasound, CT Scans, MRIs
What is being tested?
Dexmedetomidine, Midazolam and Fentanyl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
11 sitesin 2 countries
Study dates
Oct 2012to Jan 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 weeks to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • 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.
  • ≥28 weeks to <1 month: Heart Rate (HR) <120 beats per minute (bpm)
  • 1 month to <3 months: HR <100 bpm
  • 3 months to <6 months: HR <90 bpm
  • 6 months to <1 year: HR <80 bpm
  • 1 year to <2 years: HR <70 bpm
  • 2 years to <6 years: HR <60 bpm
  • 6 years to <12 years: HR <55 bpm
  • 12 years to 17 years: HR <50 bpm;
  • Note: Subject can be reassessed after 5 minutes
  • Subject has hypotension immediately before dosing, according to respective age group.
  • ≥28 weeks to <1 month: <60 mmHg (systolic blood pressure [SBP])
  • 1 month to <12 months: <70 mmHg (SBP)
  • 1 year to <10 years: <70 + (2 X age in years) mmHg (SBP)
  • 10 years to 17 years: <90 mmHg (SBP);
  • Note: Subject can be reassessed after 5 minutes
  • Subject has a presence of second-degree or third-degree heart block at screening or baseline. The presence of a temporary or permanent pacemaker will waive this exclusion criterion.
  • Subject has acute febrile illness, with a temperature (core or tympanic) ≥38.0°C.
  • Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States9 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Dallas, Texas, 75235

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Little Rock, Arkansas, 72202

  • Study site

    Miami, Florida, 33136

  • Study site

    Nashville, Tennessee, 37232-9070

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Sandy City, Utah, 84096

  • Study site

    Stanford, California, 94305

Other trials in United States

Puerto Rico2 sites

  • Study site

    San Juan, 00936-5067

  • Study site

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: Phase IV, 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 procedures, expected to take more than 30 minutes.

Read the 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01519167
Study groupRoleWhat they receive
DexmedetomidineExperimentalNot described
Receives: Drug: Dexmedetomidine; Drug: Midazolam; Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (9)

  1. Number of Subjects Not Receiving Rescue Midazolam

    Number of subjects who did not receive any rescue midazolam for sedation during the study drug infusion.

    Measured: During the treatment period, up to approximately 24 hours

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

    Measured: During the treatment period, up to approximately 24 hours

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

    Subjects who are adequately sedated (UMSS score of 1 to 3 or NPASS score of -5 to -2) at least 80% of the time sedated with the study drug

    Measured: During the treatment period, up to approximately 24 hours

  4. Time to First Dose of Rescue Midazolam From Start of Dexmedetomidine Infusion

    Kaplan-Meier estimates of time in minutes to first dose of rescue midazolam from onset of study drug infusion

    Measured: During the treatment period, up to approximately 24 hours

  5. Frequency of Midazolam Required for Sedation

    Frequency of rescue sedation (midazolam) required to maintain a subject within the target sedation range (UMSS score greater than 1 or N-PASS score less than -2).

    Measured: During the treatment period, up to approximately 24 hours

  6. Frequency of Fentanyl Use for Analgesia

    Frequency of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure.

    Measured: During the treatment period, up to approximately 24 hours

  7. Total Amount of Rescue Sedation (Midazolam)

    Total amount of rescue sedation (midazolam) required from the start of IV sedation to completion of the procedure

    Measured: During the treatment period, up to approximately 24 hours

  8. Total Amount of Rescue Analgesia (Fentanyl)

    Total amount of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure

    Measured: During the treatment period, up to approximately 24 hours

  9. Number of Subjects Converted to Alternative Sedation or Anesthetic Therapy Due to Failure of Treatment of Study Drug and Rescue Medication

    Measured: During the treatment period, up to approximately 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01519167
Sponsor's protocol ID
DEX-10-16
Status last verified
Aug 2015
First submitted
24 Jan 2012
Last updated
20 Mar 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine, Midazolam and Fentanyl in people with Ultrasound and CT Scans, run by Hospira, now a wholly owned subsidiary of Pfizer at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Who Had Success in Sedation (time frame: From baseline to end of post-treatment period (approximately 24 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01519167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.

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