Trial Outcomes & Findings for Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age (NCT NCT01159262)

NCT ID: NCT01159262

Last Updated: 2015-08-13

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

36 participants

Primary outcome timeframe

During study drug administration (6 to 24 hours)

Results posted on

2015-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine 0.05 mcg/kg 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 0.1 mcg/kg 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 0.2 mcg/kg 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 Study STARTED	14	14	8
Overall Study COMPLETED	14	14	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine 0.05 mcg/kg n=14 Participants 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 0.1 mcg/kg n=14 Participants 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 0.2 mcg/kg n=8 Participants 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 n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=93 Participants	14 Participants n=4 Participants	8 Participants n=27 Participants	36 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	1.637 weeks STANDARD_DEVIATION 1.8290 • n=93 Participants	1.098 weeks STANDARD_DEVIATION 1.0849 • n=4 Participants	2.225 weeks STANDARD_DEVIATION 1.5779 • n=27 Participants	1.558 weeks STANDARD_DEVIATION 1.5382 • n=483 Participants
Age, Customized = 28 weeks to < 36 weeks gestational age	6 Participants n=93 Participants	6 Participants n=4 Participants	0 Participants n=27 Participants	12 Participants n=483 Participants
Age, Customized >= 36 weeks to <= 44 weeks gestational age	8 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	24 Participants n=483 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	6 Participants n=4 Participants	0 Participants n=27 Participants	12 Participants n=483 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	24 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants	10 Participants n=4 Participants	6 Participants n=27 Participants	26 Participants n=483 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	8 Participants n=483 Participants
Region of Enrollment United States	14 participants n=93 Participants	14 participants n=4 Participants	8 participants n=27 Participants	36 participants n=483 Participants

PRIMARY outcome

Timeframe: During study drug administration (6 to 24 hours)

Population: Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.

Outcome measures

Outcome measures
Measure	Dexmedetomidine 0.05 mcg/kg n=14 Participants 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 0.1 mcg/kg n=14 Participants 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 0.2 mcg/kg n=8 Participants 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
Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion	7.1 percentage of subjects	7.1 percentage of subjects	25 percentage of subjects

SECONDARY outcome

Timeframe: During Study drug administration (6 to 24 hours)

Population: Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.

Outcome measures

Outcome measures
Measure	Dexmedetomidine 0.05 mcg/kg n=14 Participants 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 0.1 mcg/kg n=14 Participants 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 0.2 mcg/kg n=8 Participants 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
Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion	35.7 percentage of subjects	35.7 percentage of subjects	75 percentage of subjects

SECONDARY outcome

Timeframe: During Study drug administration (6 to 24 hours)

Population: All subjects who received midazolam during Dexmedetomidine infusion

Outcome measures

Outcome measures
Measure	Dexmedetomidine 0.05 mcg/kg n=1 Participants 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 0.1 mcg/kg n=1 Participants 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 0.2 mcg/kg n=2 Participants 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 Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)	.360 Milligram Standard Deviation NA Only 1 subject received rescue medication in the group. Standard deviation is not able to be calculated.	.500 Milligram Standard Deviation NA Only 1 subject received rescue medication in the group. Standard deviation is not able to be calculated	1.125 Milligram Standard Deviation 1.4637

SECONDARY outcome

Timeframe: During study drug administration (6 to 24 hours)

Population: All subjects who received fentanyl during Dexmedetomidine infusion

Outcome measures

Outcome measures
Measure	Dexmedetomidine 0.05 mcg/kg n=5 Participants 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 0.1 mcg/kg n=3 Participants 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 0.2 mcg/kg n=5 Participants 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 Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)	10.808 Microgram Standard Deviation 7.1305	5.667 Microgram Standard Deviation 3.5119	9.522 Microgram Standard Deviation 7.5131

SECONDARY outcome

Timeframe: During study drug administration (6 to 24 hours)

Population: All subjects who received morphine during Dexmedetomidine infusion

Outcome measures

Outcome measures
Measure	Dexmedetomidine 0.05 mcg/kg 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 0.1 mcg/kg n=2 Participants 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 0.2 mcg/kg n=3 Participants 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 Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)	—	0.275 milligram Standard Deviation 0.0354	0.400 milligram Standard Deviation 0.1732

SECONDARY outcome

Timeframe: During study drug administration (6 to 24 hours)

Population: All subjects who received midazolam during Dexmedetomidine infusion

Outcome measures

Outcome measures
Measure	Dexmedetomidine 0.05 mcg/kg n=1 Participants 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 0.1 mcg/kg n=1 Participants 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 0.2 mcg/kg n=2 Participants 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
Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)	0.100 milligrams/Kg Standard Deviation NA Only 1 subject received rescue medication in the group. Standard Deviation was not able to be calculated	0.152 milligrams/Kg Standard Deviation NA Only 1 subject received rescue medication in the group. Standard Deviation was not able to be calculated	0.318 milligrams/Kg Standard Deviation 0.4133

SECONDARY outcome

Timeframe: During study drug administration (6 to 24 hours)

Population: All subjects who received fentanyl during Dexmedetomidine infusion

Outcome measures

Outcome measures
Measure	Dexmedetomidine 0.05 mcg/kg n=5 Participants 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 0.1 mcg/kg n=3 Participants 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 0.2 mcg/kg n=5 Participants 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
Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)	5.137 microgram/Kg Standard Deviation 6.3696	1.863 microgram/Kg Standard Deviation 0.8761	2.725 microgram/Kg Standard Deviation 2.1383

SECONDARY outcome

Timeframe: During study drug administration (6 to 24 hours)

Population: All subjects who received morphine during Dexmedetomidine infusion

Outcome measures

Outcome measures
Measure	Dexmedetomidine 0.05 mcg/kg 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 0.1 mcg/kg n=2 Participants 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 0.2 mcg/kg n=3 Participants 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
Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)	—	0.125 milligram/Kg Standard Deviation 0.0348	0.109 milligram/Kg Standard Deviation 0.0540

SECONDARY outcome

Timeframe: From start of DEX administration to extubation of each subject up to 7 days post-infusion

Population: Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.

Outcome measures

Outcome measures
Measure	Dexmedetomidine 0.05 mcg/kg n=14 Participants 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 0.1 mcg/kg n=14 Participants 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 0.2 mcg/kg n=8 Participants 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
Time to Successful Extubation in DEX-exposed Subjects	22.9 hour Interval 4.467 to 100.67	49.3 hour Interval 33.167 to 79.583	23.7 hour Interval 4.667 to 67.333

Adverse Events

Dexmedetomidine 0.05 mcg/kg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Dexmedetomidine 0.1 mcg/kg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Dexmedetomidine 0.2 mcg/kg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dexmedetomidine 0.05 mcg/kg n=14 participants at risk 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 0.1 mcg/kg n=14 participants at risk 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 0.2 mcg/kg n=8 participants at risk 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
Cardiac disorders Bradycardia	0.00% 0/14 • 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). Patients were monitored for safety parameters from 6 to 24 hours in the ICU.	7.1% 1/14 • Number of events 1 • 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). Patients were monitored for safety parameters from 6 to 24 hours in the ICU.	0.00% 0/8 • 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). Patients were monitored for safety parameters from 6 to 24 hours in the ICU.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/14 • 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). Patients were monitored for safety parameters from 6 to 24 hours in the ICU.	7.1% 1/14 • Number of events 1 • 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). Patients were monitored for safety parameters from 6 to 24 hours in the ICU.	0.00% 0/8 • 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). Patients were monitored for safety parameters from 6 to 24 hours in the ICU.
Investigations Oxygen saturation decreased	0.00% 0/14 • 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). Patients were monitored for safety parameters from 6 to 24 hours in the ICU.	7.1% 1/14 • Number of events 1 • 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). Patients were monitored for safety parameters from 6 to 24 hours in the ICU.	0.00% 0/8 • 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). Patients were monitored for safety parameters from 6 to 24 hours in the ICU.

Other adverse events

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