Trial Outcomes & Findings for Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects (NCT NCT00875550)
NCT ID: NCT00875550
Last Updated: 2015-08-14
Results Overview
Clinical Score Level of Sedation 0 Awake/Alert 1. Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2. Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3. Deeply sedated: Deep sleep, arousable only with significant physical stimulation. 4. Unarousable
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
175 participants
Primary outcome timeframe
6 to 24 hours
Results posted on
2015-08-14
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine Low Dose
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
86
|
|
Overall Study
COMPLETED
|
77
|
76
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
Baseline characteristics by cohort
| Measure |
Dexmedetomidine Low Dose
n=89 Participants
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
n=86 Participants
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.35 years
STANDARD_DEVIATION 3.437 • n=5 Participants
|
2.85 years
STANDARD_DEVIATION 4.172 • n=7 Participants
|
2.60 years
STANDARD_DEVIATION 3.814 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
89 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
>= 1 month to < 24 months
|
63 participants
n=5 Participants
|
60 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Age, Customized
>=24 months to < 17 years old
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
American Society of Anaesthesiologists (ASA) classification
P1 - Normal healthy patient (PT)
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
American Society of Anaesthesiologists (ASA) classification
P2 - PT w/ mild systemic disease
|
28 participants
n=5 Participants
|
16 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
American Society of Anaesthesiologists (ASA) classification
P3 - PT w/ severe systemic disease)
|
50 participants
n=5 Participants
|
53 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
American Society of Anaesthesiologists (ASA) classification
P4 - PT w/ constant threat to life)
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
American Society of Anaesthesiologists (ASA) classification
P5 - Moribund patient
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
American Society of Anaesthesiologists (ASA) classification
P6 - A declared brain-dead patient
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 to 24 hoursPopulation: Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Clinical Score Level of Sedation 0 Awake/Alert 1. Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2. Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3. Deeply sedated: Deep sleep, arousable only with significant physical stimulation. 4. Unarousable
Outcome measures
| Measure |
Dexmedetomidine Low Dose
n=83 Participants
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
n=81 Participants
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
|---|---|---|
|
Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated.
|
44.6 Percentage of subjects
|
54.3 Percentage of subjects
|
SECONDARY outcome
Timeframe: 6 to 24 hoursPopulation: Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Outcome measures
| Measure |
Dexmedetomidine Low Dose
n=83 Participants
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
n=81 Participants
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
|---|---|---|
|
Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated
|
17.2 Hours
Interval 5.0 to 24.0
|
17.3 Hours
Interval 2.0 to 24.0
|
SECONDARY outcome
Timeframe: 6 to 24 hoursPopulation: Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Outcome measures
| Measure |
Dexmedetomidine Low Dose
n=83 Participants
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
n=81 Participants
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
|---|---|---|
|
Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated
|
1.0 hours
Interval 0.0 to 10.0
|
0.7 hours
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: 6 to 24 hoursPopulation: Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Outcome measures
| Measure |
Dexmedetomidine Low Dose
n=83 Participants
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
n=81 Participants
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
|---|---|---|
|
Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated
Midazolam
|
2.221 Milligram
Standard Deviation 4.6089
|
1.241 Milligram
Standard Deviation 2.3052
|
|
Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated
Fentanyl
|
45.225 Milligram
Standard Deviation 83.7743
|
44.367 Milligram
Standard Deviation 112.13
|
|
Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated
Morphine
|
1.446 Milligram
Standard Deviation 3.2978
|
1.141 Milligram
Standard Deviation 2.4209
|
SECONDARY outcome
Timeframe: 6 to 24 hoursPopulation: Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Outcome measures
| Measure |
Dexmedetomidine Low Dose
n=83 Participants
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
n=81 Participants
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
|---|---|---|
|
Time to First Dose of Rescue Medication for Sedation and Analgesia
|
1.6 Hours
Interval 0.933 to 3.383
|
2.0 Hours
Interval 1.067 to 3.75
|
SECONDARY outcome
Timeframe: 6 to 24 hoursPopulation: Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours
Outcome measures
| Measure |
Dexmedetomidine Low Dose
n=83 Participants
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
n=81 Participants
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
|---|---|---|
|
Time to Successful Extubation
|
23.8 Hours
Interval 18.55 to
Computation for the 95% confidence interval (CI) from the Kaplan-Meier analysis requires adequate number of events to be estimable. There were not enough events to fully characterize the complete CI, only point estimate and the 95% lower CI estimate.
|
20.5 Hours
Interval 17.133 to 23.333
|
Adverse Events
Dexmedetomidine Low Dose
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Dexmedetomidine High Dose
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexmedetomidine Low Dose
n=89 participants at risk
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
n=86 participants at risk
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
|---|---|---|
|
Cardiac disorders
Myocarditis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/89
|
1.2%
1/86 • Number of events 1
|
Other adverse events
| Measure |
Dexmedetomidine Low Dose
n=89 participants at risk
Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
Dexmedetomidine High Dose
n=86 participants at risk
Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)
Midazolam: Rescue medication for sedation according to UMSS scores
Fentanyl: Rescue medication for pain based on UMSS scores
Morphine: Rescue medication for pain based on UMSS scores.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/89
|
2.3%
2/86
|
|
Cardiac disorders
Bradycardia
|
2.2%
2/89
|
3.5%
3/86
|
|
Cardiac disorders
Extrasystoles
|
1.1%
1/89
|
0.00%
0/86
|
|
Cardiac disorders
Nodal rhythm
|
1.1%
1/89
|
0.00%
0/86
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/89
|
2.3%
2/86
|
|
Cardiac disorders
Ventricular fibrillation
|
1.1%
1/89
|
0.00%
0/86
|
|
Gastrointestinal disorders
Constipation
|
1.1%
1/89
|
0.00%
0/86
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
2/89
|
0.00%
0/86
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/89
|
1.2%
1/86
|
|
Gastrointestinal disorders
Nausea
|
3.4%
3/89
|
2.3%
2/86
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/89
|
4.7%
4/86
|
|
General disorders
Chest pain
|
1.1%
1/89
|
0.00%
0/86
|
|
General disorders
Drug withdrawal syndrome
|
2.2%
2/89
|
0.00%
0/86
|
|
General disorders
General symptom
|
1.1%
1/89
|
0.00%
0/86
|
|
General disorders
Inflammation
|
1.1%
1/89
|
0.00%
0/86
|
|
General disorders
Infusion site extravasation
|
0.00%
0/89
|
1.2%
1/86
|
|
General disorders
Oedema peripheral
|
0.00%
0/89
|
1.2%
1/86
|
|
General disorders
Pain
|
1.1%
1/89
|
1.2%
1/86
|
|
General disorders
Pyrexia
|
7.9%
7/89
|
5.8%
5/86
|
|
Infections and infestations
Parainfluenzae virus infection
|
1.1%
1/89
|
0.00%
0/86
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/89
|
1.2%
1/86
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/89
|
1.2%
1/86
|
|
Injury, poisoning and procedural complications
Device electrical finding
|
0.00%
0/89
|
1.2%
1/86
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/89
|
2.3%
2/86
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Alanine aminotransferase abnormal
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Base excess decreased
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Blood albumin abnormal
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Blood alkaline phosphatase increased
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Blood cortisol increased
|
0.00%
0/89
|
1.2%
1/86
|
|
Investigations
Blood culture positive
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Blood fibrinogen decreased
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Blood glucose increased
|
1.1%
1/89
|
1.2%
1/86
|
|
Investigations
Blood magnesium abnormal
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Blood magnesium decreased
|
1.1%
1/89
|
1.2%
1/86
|
|
Investigations
Blood pH decreased
|
2.2%
2/89
|
0.00%
0/86
|
|
Investigations
Blood phosphorus decreased
|
2.2%
2/89
|
2.3%
2/86
|
|
Investigations
Blood potassium abnormal
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/89
|
1.2%
1/86
|
|
Investigations
Carbon dioxide decreased
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Central venous pressure decreased
|
0.00%
0/89
|
1.2%
1/86
|
|
Investigations
Culture positive
|
0.00%
0/89
|
1.2%
1/86
|
|
Investigations
Culture urine positive
|
0.00%
0/89
|
1.2%
1/86
|
|
Investigations
Electrocardiogram
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/89
|
2.3%
2/86
|
|
Investigations
Haematocrit decreased
|
2.2%
2/89
|
0.00%
0/86
|
|
Investigations
Haemoglobin decreased
|
2.2%
2/89
|
0.00%
0/86
|
|
Investigations
Heart rate decreased
|
0.00%
0/89
|
1.2%
1/86
|
|
Investigations
Heart rate irregular
|
2.2%
2/89
|
0.00%
0/86
|
|
Investigations
Oxygen saturation decreased
|
1.1%
1/89
|
3.5%
3/86
|
|
Investigations
PCO2 increased
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Platelet count decreased
|
2.2%
2/89
|
0.00%
0/86
|
|
Investigations
Platelet count increased
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Red blood cell count decreased
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Respiratory rate decreased
|
2.2%
2/89
|
0.00%
0/86
|
|
Investigations
Sputum culture positive
|
1.1%
1/89
|
0.00%
0/86
|
|
Investigations
Urine output decreased
|
0.00%
0/89
|
2.3%
2/86
|
|
Investigations
White blood cell count increased
|
0.00%
0/89
|
1.2%
1/86
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/89
|
1.2%
1/86
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
1.1%
1/89
|
0.00%
0/86
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
3/89
|
1.2%
1/86
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.1%
1/89
|
0.00%
0/86
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.1%
9/89
|
5.8%
5/86
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
1/89
|
1.2%
1/86
|
|
Nervous system disorders
Convulsion
|
1.1%
1/89
|
0.00%
0/86
|
|
Nervous system disorders
Crying
|
1.1%
1/89
|
0.00%
0/86
|
|
Nervous system disorders
Status epilepticus
|
1.1%
1/89
|
0.00%
0/86
|
|
Psychiatric disorders
Agitation
|
4.5%
4/89
|
5.8%
5/86
|
|
Psychiatric disorders
Anxiety
|
2.2%
2/89
|
0.00%
0/86
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/89
|
1.2%
1/86
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/89
|
2.3%
2/86
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.4%
3/89
|
4.7%
4/86
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
0.00%
0/89
|
1.2%
1/86
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/89
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/89
|
1.2%
1/86
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
1/89
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
1.1%
1/89
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
2/89
|
3.5%
3/86
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
1.1%
1/89
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.2%
2/89
|
2.3%
2/86
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.4%
3/89
|
2.3%
2/86
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
1.1%
1/89
|
1.2%
1/86
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract inflammation
|
0.00%
0/89
|
1.2%
1/86
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.2%
2/89
|
2.3%
2/86
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/89
|
1.2%
1/86
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.4%
3/89
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
2.2%
2/89
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/89
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/89
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
1.1%
1/89
|
0.00%
0/86
|
|
Vascular disorders
Hypertension
|
7.9%
7/89
|
0.00%
0/86
|
|
Vascular disorders
Hypotension
|
4.5%
4/89
|
8.1%
7/86
|
Additional Information
Marcelo Garcia de Rocha MD, Global Medical Director
Hospira
Phone: 224-212-4424
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place