Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01519167
Recruitment Status : Completed
First Posted : January 26, 2012
Results First Posted : August 14, 2015
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ultrasound
CT Scans
MRIs
Interventions Drug: Dexmedetomidine
Drug: Midazolam
Drug: Fentanyl
Enrollment 91
Recruitment Details  
Pre-assignment Details The number of subjects enrolled was 91, of that 90 subjects received study drug. The remaining 1 subject not treated due to subject being a screen failure.
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Period Title: Overall Study
Started 1 89
Completed 1 81
Not Completed 0 8
Reason Not Completed
Diagnostic/TherapeuticProcedureCompleted             0             3
Adverse Event             0             1
Lack of Efficacy             0             1
Medical condition changes&deep sedation             0             2
Physician Decision             0             1
Arm/Group Title Dose Level 1 Dose Level 2 Total
Hide Arm/Group Description Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr Total of all reporting groups
Overall Number of Baseline Participants 1 89 90
Hide Baseline Analysis Population Description
Safety Evaluable Population: All subjects who receive any amount of study drug. All safety analyses will be performed on this population.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 89 participants 90 participants
0.1
(0.1 to 0.1)
7.97
(0.3 to 17.3)
7.89
(0.1 to 17.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 89 participants 90 participants
Female
0
   0.0%
41
  46.1%
41
  45.6%
Male
1
 100.0%
48
  53.9%
49
  54.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 89 participants 90 participants
Hispanic or Latino
0
   0.0%
23
  25.8%
23
  25.6%
Not Hispanic or Latino
1
 100.0%
66
  74.2%
67
  74.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 89 participants 90 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.1%
1
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
 100.0%
22
  24.7%
23
  25.6%
White
0
   0.0%
60
  67.4%
60
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
6
   6.7%
6
   6.7%
1.Primary Outcome
Title Number of Subjects Who Had Success in Sedation
Hide Description

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
Time Frame From baseline to end of post-treatment period (approximately 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 1 77
Measure Type: Number
Unit of Measure: participants
NIDTP (n=1, 40) 0 2
MIDTP (n=0, 25) 0 0
Surgical procedures (n=0, 12) 0 0
2.Secondary Outcome
Title Number of Subjects Not Receiving Rescue Midazolam
Hide Description Number of subjects who did not receive any rescue midazolam for sedation during the study drug infusion.
Time Frame During the treatment period, up to approximately 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 1 77
Measure Type: Number
Unit of Measure: participants
NIDTP (n=1, 40) 1 12
MIDTP (n=0, 25) 0 5
Surgical procedures (n=0, 12) 0 1
3.Secondary Outcome
Title Number of Subjects Who Have Undergone Procedures Without Artificial Ventilation or Intervention
Hide Description [Not Specified]
Time Frame During the treatment period, up to approximately 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 1 77
Measure Type: Number
Unit of Measure: participants
NIDTP (n=1, 40) 1 37
MIDTP (n=0, 25) 0 19
Surgical procedures (n=0, 12) 0 12
4.Secondary Outcome
Title Number of Subjects Who Were Adequately Sedated at Least 80% of Time
Hide Description 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
Time Frame During the treatment period, up to approximately 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 1 77
Measure Type: Number
Unit of Measure: participants
NIDTP (n=1, 40) 0 21
MIDTP (n=0, 25) 0 7
Surgical procedures (n=0, 12) 0 2
5.Secondary Outcome
Title Time to First Dose of Rescue Midazolam From Start of Dexmedetomidine Infusion
Hide Description Kaplan-Meier estimates of time in minutes to first dose of rescue midazolam from onset of study drug infusion
Time Frame During the treatment period, up to approximately 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 1 77
Median (95% Confidence Interval)
Unit of Measure: Hours
NIDTP (n=1, 40) NA [1] 
23.5
(16.00 to 28.00)
MIDTP (n=0, 25) NA [2] 
20.00
(17.00 to 34.00)
Surgical procedures (n=0, 12) NA [3] 
20.00
(15.00 to 25.00)
[1]
There was one subject in this group (n=1) and the subject did not receive rescue midazolam.
[2]
No subjects were in the MIDTP group
[3]
No subjects were in the surgical procedures group
6.Secondary Outcome
Title Frequency of Midazolam Required for Sedation
Hide Description 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).
Time Frame During the treatment period, up to approximately 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 0 59
Median (Full Range)
Unit of Measure: Occurrence
NIDTP (n=0, 28)
2
(1 to 4)
MIDTP (n=0, 20)
1
(1 to 2)
Surgical procedures (n=0, 11)
1
(1 to 2)
7.Secondary Outcome
Title Frequency of Fentanyl Use for Analgesia
Hide Description Frequency of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure.
Time Frame During the treatment period, up to approximately 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 0 40
Median (Full Range)
Unit of Measure: Occurrence
NIDTP (n=0, 6)
1
(1 to 3)
MIDTP (n=0, 22)
1
(1 to 5)
Surgical procedures (n=0, 12)
2.50
(1 to 5)
8.Secondary Outcome
Title Total Amount of Rescue Sedation (Midazolam)
Hide Description Total amount of rescue sedation (midazolam) required from the start of IV sedation to completion of the procedure
Time Frame During the treatment period, up to approximately 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 0 59
Mean (Standard Deviation)
Unit of Measure: milligram
NIDTP (n=0, 28) 2.62  (1.611)
MIDTP (n=0, 20) 1.70  (0.767)
Surgical procedures (n=0, 11) 2.45  (0.907)
9.Secondary Outcome
Title Total Amount of Rescue Analgesia (Fentanyl)
Hide Description Total amount of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure
Time Frame During the treatment period, up to approximately 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 0 40
Mean (Standard Deviation)
Unit of Measure: microgram
NIDTP (n=0, 6) 10.83  (8.010)
MIDTP (n=0, 22) 61.86  (65.740)
Surgical procedures (n=0, 12) 104.83  (72.007)
10.Secondary Outcome
Title Number of Subjects Converted to Alternative Sedation or Anesthetic Therapy Due to Failure of Treatment of Study Drug and Rescue Medication
Hide Description [Not Specified]
Time Frame During the treatment period, up to approximately 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
Overall Number of Participants Analyzed 1 77
Measure Type: Number
Unit of Measure: Participants
NIDTP (n=1, 40) 0 0
MIDTP (n=0, 25) 0 0
Surgical procedures (n=0, 12) 0 2
Time Frame Non-serious adverse events from start of study drug administration until 24(±12) hours following study drug discontinuation. Reported serious adverse events from the time the subject signed informed consent until 30 days after study drug discontinuation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
All-Cause Mortality
Dose Level 1 Dose Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Dose Level 1 Dose Level 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      1/89 (1.12%)    
Nervous system disorders     
Syncope  1  0/1 (0.00%)  0 1/89 (1.12%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Dose Level 1 Dose Level 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      66/89 (74.16%)    
Cardiac disorders     
Bradycardia  1  0/1 (0.00%)  4/89 (4.49%) 
Tachycardia  1  0/1 (0.00%)  1/89 (1.12%) 
Gastrointestinal disorders     
Diarrhoea  1  0/1 (0.00%)  1/89 (1.12%) 
Nausea  1  0/1 (0.00%)  2/89 (2.25%) 
Vomiting  1  0/1 (0.00%)  2/89 (2.25%) 
Investigations     
Blood pressure diastolic decreased  1  0/1 (0.00%)  2/89 (2.25%) 
Blood pressure systolic decreased  1  0/1 (0.00%)  3/89 (3.37%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  0/1 (0.00%)  1/89 (1.12%) 
Hyperkalaemia  1  0/1 (0.00%)  1/89 (1.12%) 
Nervous system disorders     
Headache  1  0/1 (0.00%)  3/89 (3.37%) 
Somnolence  1  0/1 (0.00%)  1/89 (1.12%) 
Psychiatric disorders     
Agitation  1  0/1 (0.00%)  1/89 (1.12%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  0/1 (0.00%)  2/89 (2.25%) 
Respiratory depression  1  1/1 (100.00%)  53/89 (59.55%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/1 (0.00%)  1/89 (1.12%) 
Vascular disorders     
Hypertension  1  0/1 (0.00%)  2/89 (2.25%) 
Hypotension  1  0/1 (0.00%)  37/89 (41.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Investigator may not submit the results of the study for publication without the prior written consent of Hospira.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marcelo Garcia de Rocha MD, Global Medical Director
Organization: Hospira
Phone: 224-212-4424
EMail: marcelo.rocha@hospira.com
Layout table for additonal information
Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT01519167    
Other Study ID Numbers: DEX-10-16
First Submitted: January 24, 2012
First Posted: January 26, 2012
Results First Submitted: May 5, 2015
Results First Posted: August 14, 2015
Last Update Posted: March 20, 2017