Trial Outcomes & Findings for Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation (NCT NCT01528891)
NCT ID: NCT01528891
Last Updated: 2018-03-08
Results Overview
beats per minute (bpm)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
418 participants
Primary outcome timeframe
Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).
Results posted on
2018-03-08
Participant Flow
418 patients overall were enrolled in the study. Of these patients, 18 failed screening prior to randomization into either treatment arm.
Participant milestones
| Measure |
Dexmedetomidine
Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery
|
Placebo
Normal saline equivalent volume
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
|
Overall Study
COMPLETED
|
200
|
200
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=195 Participants
Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery
Of the 200 patients in this treatment arm, 5 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol.
|
Placebo
n=198 Participants
Normal saline equivalent volume
Placebo
Of the 200 patients in this treatment arm, 2 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol.
|
Total
n=393 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
195 Participants
n=99 Participants
|
198 Participants
n=107 Participants
|
393 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
6.1 years
STANDARD_DEVIATION 1.6 • n=99 Participants
|
5.8 years
STANDARD_DEVIATION 1.6 • n=107 Participants
|
6.0 years
STANDARD_DEVIATION 1.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
195 participants
n=99 Participants
|
198 participants
n=107 Participants
|
393 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).Population: Heart rate values were compared between groups at each time point and within groups over time.
beats per minute (bpm)
Outcome measures
| Measure |
Dexmedetomidine
n=195 Participants
Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
|
Placebo
n=198 Participants
Normal saline
Placebo
|
|---|---|---|
|
Heart Rate (HR)
2 min HR
|
104 bpm
Standard Deviation 16
|
120 bpm
Standard Deviation 15
|
|
Heart Rate (HR)
Baseline HR
|
120 bpm
Standard Deviation 16
|
121 bpm
Standard Deviation 16
|
|
Heart Rate (HR)
1 min HR
|
107 bpm
Standard Deviation 18
|
121 bpm
Standard Deviation 16
|
|
Heart Rate (HR)
3 min HR
|
105 bpm
Standard Deviation 14
|
119 bpm
Standard Deviation 15
|
|
Heart Rate (HR)
4 min HR
|
105 bpm
Standard Deviation 15
|
118 bpm
Standard Deviation 15
|
|
Heart Rate (HR)
5 min HR
|
105 bpm
Standard Deviation 15
|
117 bpm
Standard Deviation 15
|
|
Heart Rate (HR)
PACU HR
|
94 bpm
Standard Deviation 13
|
108 bpm
Standard Deviation 16
|
PRIMARY outcome
Timeframe: Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).Population: Systolic blood pressure values were compared between groups at each time point and within groups over time.
mmHg Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis.
Outcome measures
| Measure |
Dexmedetomidine
n=194 Participants
Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
|
Placebo
n=197 Participants
Normal saline
Placebo
|
|---|---|---|
|
Systolic Blood Pressure (SBP)
Baseline SBP
|
99 mmHg
Standard Deviation 16
|
99 mmHg
Standard Deviation 16
|
|
Systolic Blood Pressure (SBP)
1 min SBP
|
104 mmHg
Standard Deviation 16
|
100 mmHg
Standard Deviation 15
|
|
Systolic Blood Pressure (SBP)
2 min SBP
|
99 mmHg
Standard Deviation 14
|
99 mmHg
Standard Deviation 14
|
|
Systolic Blood Pressure (SBP)
3 min SBP
|
95 mmHg
Standard Deviation 13
|
98 mmHg
Standard Deviation 14
|
|
Systolic Blood Pressure (SBP)
4 min SBP
|
93 mmHg
Standard Deviation 13
|
97 mmHg
Standard Deviation 15
|
|
Systolic Blood Pressure (SBP)
5 min SBP
|
92 mmHg
Standard Deviation 13
|
96 mmHg
Standard Deviation 15
|
|
Systolic Blood Pressure (SBP)
PACU SBP
|
97 mmHg
Standard Deviation 12
|
105 mmHg
Standard Deviation 17
|
PRIMARY outcome
Timeframe: Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).Population: Diastolic blood pressure values were compared between groups at each time point and within groups over time.
mmHg Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis.
Outcome measures
| Measure |
Dexmedetomidine
n=194 Participants
Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
|
Placebo
n=196 Participants
Normal saline
Placebo
|
|---|---|---|
|
Diastolic Blood Pressure (DBP)
Baseline DBP
|
47 mmHg
Standard Deviation 9
|
47 mmHg
Standard Deviation 9
|
|
Diastolic Blood Pressure (DBP)
1 min DBP
|
52 mmHg
Standard Deviation 10
|
47 mmHg
Standard Deviation 9
|
|
Diastolic Blood Pressure (DBP)
2 min DBP
|
48 mmHg
Standard Deviation 9
|
47 mmHg
Standard Deviation 8
|
|
Diastolic Blood Pressure (DBP)
3 min DBP
|
45 mmHg
Standard Deviation 8
|
46 mmHg
Standard Deviation 8
|
|
Diastolic Blood Pressure (DBP)
4 min DBP
|
44 mmHg
Standard Deviation 8
|
45 mmHg
Standard Deviation 9
|
|
Diastolic Blood Pressure (DBP)
5 min DBP
|
43 mmHg
Standard Deviation 8
|
45 mmHg
Standard Deviation 8
|
|
Diastolic Blood Pressure (DBP)
PACU DBP
|
50 mmHg
Standard Deviation 7
|
55 mmHg
Standard Deviation 11
|
SECONDARY outcome
Timeframe: The highest PAED score for each patient within the first 30 minutes after waking up was recorded.Population: There were 2 patients in the Dexmedetomidine group and 9 patients in the placebo group who were excluded from analysis of emergence agitation. These patients were excluded because they received medications that were not a part of the anesthetic protocol and could affect their PAED score.
Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded. The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up. These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation. For this study, patients with a maximum PAED score of \>10 and \>12 were considered to be agitated.
Outcome measures
| Measure |
Dexmedetomidine
n=193 Participants
Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
|
Placebo
n=189 Participants
Normal saline
Placebo
|
|---|---|---|
|
Incidence of Emergence Agitation (EA)
EA using PAED >10 threshold
|
36 percentage of patients with EA
|
66 percentage of patients with EA
|
|
Incidence of Emergence Agitation (EA)
EA using PAED >12 threshold
|
30 percentage of patients with EA
|
61 percentage of patients with EA
|
Adverse Events
Dexmedetomidine
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexmedetomidine
n=200 participants at risk
Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery
|
Placebo
n=200 participants at risk
Normal saline equivalent volume
Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Desaturation with Atelectasis
|
0.50%
1/200 • Number of events 1
|
0.00%
0/200
|
Other adverse events
| Measure |
Dexmedetomidine
n=200 participants at risk
Dexmedetomidine
Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery
|
Placebo
n=200 participants at risk
Normal saline equivalent volume
Placebo
|
|---|---|---|
|
General disorders
Dizziness
|
0.50%
1/200 • Number of events 1
|
0.00%
0/200
|
|
General disorders
Headache
|
0.50%
1/200 • Number of events 1
|
1.0%
2/200 • Number of events 2
|
|
General disorders
Congestion
|
1.5%
3/200 • Number of events 3
|
0.00%
0/200
|
|
General disorders
Bronchospasm
|
0.00%
0/200
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Laryngospasm
|
0.00%
0/200
|
3.5%
7/200 • Number of events 7
|
|
General disorders
Tachypnea
|
0.50%
1/200 • Number of events 1
|
0.00%
0/200
|
|
General disorders
Stridor
|
0.50%
1/200 • Number of events 1
|
1.5%
3/200 • Number of events 3
|
|
General disorders
Hypercapnia
|
0.00%
0/200
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Apnea
|
0.50%
1/200 • Number of events 1
|
0.00%
0/200
|
|
General disorders
Emesis
|
1.5%
3/200 • Number of events 3
|
1.0%
2/200 • Number of events 2
|
|
General disorders
Croupy Cough
|
0.50%
1/200 • Number of events 1
|
1.5%
3/200 • Number of events 3
|
|
General disorders
Desaturation
|
0.50%
1/200 • Number of events 1
|
2.5%
5/200 • Number of events 5
|
|
General disorders
Enuresis
|
1.0%
2/200 • Number of events 2
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Bigeminal Premature Atrial Contractions
|
0.50%
1/200 • Number of events 1
|
0.00%
0/200
|
|
General disorders
Nausea
|
0.50%
1/200 • Number of events 1
|
1.5%
3/200 • Number of events 3
|
|
General disorders
Rigor
|
0.00%
0/200
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Wheezing
|
0.00%
0/200
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Pruritus
|
0.00%
0/200
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Swelling
|
0.00%
0/200
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Excess Secretions
|
0.00%
0/200
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Intravenous Infiltration
|
0.00%
0/200
|
0.50%
1/200 • Number of events 1
|
|
General disorders
Bleeding
|
2.0%
4/200 • Number of events 4
|
4.5%
9/200 • Number of events 9
|
|
General disorders
Kinked intravenous catheter
|
0.50%
1/200 • Number of events 1
|
0.00%
0/200
|
|
General disorders
Poor oral intake
|
0.50%
1/200 • Number of events 1
|
0.00%
0/200
|
Additional Information
Peter J. Davis, MD
Children's Hospital of Pittsburgh of UPMC
Phone: 4126925260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place