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Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

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ClinicalTrials.gov Identifier: NCT01159262
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : December 12, 2014
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sedation
Interventions Drug: Midazolam
Drug: Fentanyl/Morphine
Drug: Dexmedetomidine
Enrollment 36

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Period Title: Overall Study
Started 14 14 8
Completed 14 14 8
Not Completed 0 0 0
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg Total
Hide Arm/Group Description

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Total of all reporting groups
Overall Number of Baseline Participants 14 14 8 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 8 participants 36 participants
<=18 years
14
 100.0%
14
 100.0%
8
 100.0%
36
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 14 participants 14 participants 8 participants 36 participants
1.637  (1.8290) 1.098  (1.0849) 2.225  (1.5779) 1.558  (1.5382)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 8 participants 36 participants
= 28 weeks to < 36 weeks gestational age 6 6 0 12
>= 36 weeks to <= 44 weeks gestational age 8 8 8 24
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 8 participants 36 participants
Female
6
  42.9%
6
  42.9%
0
   0.0%
12
  33.3%
Male
8
  57.1%
8
  57.1%
8
 100.0%
24
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 8 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   7.1%
0
   0.0%
1
   2.8%
White
10
  71.4%
10
  71.4%
6
  75.0%
26
  72.2%
More than one race
1
   7.1%
0
   0.0%
0
   0.0%
1
   2.8%
Unknown or Not Reported
3
  21.4%
3
  21.4%
2
  25.0%
8
  22.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 8 participants 36 participants
14 14 8 36
1.Primary Outcome
Title Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion
Hide Description [Not Specified]
Time Frame During study drug administration (6 to 24 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description:

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Overall Number of Participants Analyzed 14 14 8
Measure Type: Number
Unit of Measure: percentage of subjects
7.1 7.1 25
2.Secondary Outcome
Title Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion
Hide Description [Not Specified]
Time Frame During Study drug administration (6 to 24 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description:

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Overall Number of Participants Analyzed 14 14 8
Measure Type: Number
Unit of Measure: percentage of subjects
35.7 35.7 75
3.Secondary Outcome
Title Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Hide Description [Not Specified]
Time Frame During Study drug administration (6 to 24 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who received midazolam during Dexmedetomidine infusion
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description:

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Overall Number of Participants Analyzed 1 1 2
Mean (Standard Deviation)
Unit of Measure: Milligram
.360 [1]   (NA) .500 [2]   (NA) 1.125  (1.4637)
[1]
Only 1 subject received rescue medication in the group. Standard deviation is not able to be calculated.
[2]
Only 1 subject received rescue medication in the group. Standard deviation is not able to be calculated
4.Secondary Outcome
Title Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Hide Description [Not Specified]
Time Frame During study drug administration (6 to 24 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who received fentanyl during Dexmedetomidine infusion
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description:

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Overall Number of Participants Analyzed 5 3 5
Mean (Standard Deviation)
Unit of Measure: Microgram
10.808  (7.1305) 5.667  (3.5119) 9.522  (7.5131)
5.Secondary Outcome
Title Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Hide Description [Not Specified]
Time Frame During study drug administration (6 to 24 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who received morphine during Dexmedetomidine infusion
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description:

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Overall Number of Participants Analyzed 0 2 3
Mean (Standard Deviation)
Unit of Measure: milligram
0.275  (0.0354) 0.400  (0.1732)
6.Secondary Outcome
Title Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Hide Description [Not Specified]
Time Frame During study drug administration (6 to 24 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who received midazolam during Dexmedetomidine infusion
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description:

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Overall Number of Participants Analyzed 1 1 2
Mean (Standard Deviation)
Unit of Measure: milligrams/Kg
0.100 [1]   (NA) 0.152 [1]   (NA) 0.318  (0.4133)
[1]
Only 1 subject received rescue medication in the group. Standard Deviation was not able to be calculated
7.Secondary Outcome
Title Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)
Hide Description [Not Specified]
Time Frame During study drug administration (6 to 24 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who received fentanyl during Dexmedetomidine infusion
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description:

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Overall Number of Participants Analyzed 5 3 5
Mean (Standard Deviation)
Unit of Measure: microgram/Kg
5.137  (6.3696) 1.863  (0.8761) 2.725  (2.1383)
8.Secondary Outcome
Title Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)
Hide Description [Not Specified]
Time Frame During study drug administration (6 to 24 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who received morphine during Dexmedetomidine infusion
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description:

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Overall Number of Participants Analyzed 0 2 3
Mean (Standard Deviation)
Unit of Measure: milligram/Kg
0.125  (0.0348) 0.109  (0.0540)
9.Secondary Outcome
Title Time to Successful Extubation in DEX-exposed Subjects
Hide Description [Not Specified]
Time Frame From start of DEX administration to extubation of each subject up to 7 days post-infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description:

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Overall Number of Participants Analyzed 14 14 8
Median (95% Confidence Interval)
Unit of Measure: hour
22.9
(4.467 to 100.67)
49.3
(33.167 to 79.583)
23.7
(4.667 to 67.333)
Time Frame Start of study drug administration until 7 days following the start of study drug. Serious adverse events collected from signing of informed consent until 7 days following start of study drug administration or hospital discharge (whichever comes first).
Adverse Event Reporting Description Patients were monitored for safety parameters from 6 to 24 hours in the ICU.
 
Arm/Group Title Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Hide Arm/Group Description

Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.

Midazolam: Per package insert, N-PASS scores and investigator discretion

Fentanyl: Per package insert, N-PASS scores and investigator discretion.

Dexmedetomidine

All-Cause Mortality
Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      1/14 (7.14%)      0/8 (0.00%)    
Cardiac disorders       
Bradycardia * 1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Cardio-respiratory arrest * 1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Investigations       
Oxygen saturation decreased * 1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.8%
Dexmedetomidine 0.05 mcg/kg Dexmedetomidine 0.1 mcg/kg Dexmedetomidine 0.2 mcg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/14 (50.00%)      9/14 (64.29%)      6/8 (75.00%)    
Blood and lymphatic system disorders       
Anemia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Cardiac disorders       
Tachycardia  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Congenital, familial and genetic disorders       
Patent ductus arteriosus  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Gastrointestinal disorders       
Diarrhea  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Vomiting  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
General disorders       
Infusion site extravasation  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Edema  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Hepatobiliary disorders       
Hyperbiliruninaemia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Jaundice  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations       
Abscess neck  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Sepsis  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Injury, poisoning and procedural complications       
Shunt stenosis  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Investigations       
Blood bilirubin unconjugated increased  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Blood potassium decreased  1  2/14 (14.29%)  2 0/14 (0.00%)  0 0/8 (0.00%)  0
Hemoglobin decreased  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Metabolism and nutrition disorders       
Fluid retention  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Hyperglycemia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Hypoalbuminaemia  1  0/14 (0.00%)  0 3/14 (21.43%)  3 0/8 (0.00%)  0
Hypocalcaemia  1  1/14 (7.14%)  1 1/14 (7.14%)  1 0/8 (0.00%)  0
Hypokalaemia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 3/8 (37.50%)  3
Hypoproteinaemia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Psychiatric disorders       
Anger  1  0/14 (0.00%)  0 3/14 (21.43%)  3 3/8 (37.50%)  3
Renal and urinary disorders       
Hematuria  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Atelectasis  1  1/14 (7.14%)  1 0/14 (0.00%)  0 1/8 (12.50%)  1
Atelectasis neonatal  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Hypopnoea  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Plueral effusion  1  0/14 (0.00%)  0 0/14 (0.00%)  0 2/8 (25.00%)  2
Pulmonary edema  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1
Respiratory acidosis  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Vascular disorders       
Diastolic hypotension  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0
Hypertension  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Marcelo Garcia de Rocha MD, Global Medical Director
Organization: Hospira
Phone: 224-212-4424
Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT01159262     History of Changes
Other Study ID Numbers: DEX-09-08
First Submitted: June 30, 2010
First Posted: July 9, 2010
Results First Submitted: January 24, 2014
Results First Posted: December 12, 2014
Last Update Posted: August 13, 2015