Trial Outcomes & Findings for Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation (NCT NCT02256358)
NCT ID: NCT02256358
Last Updated: 2014-10-20
Results Overview
The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes
Results posted on
2014-10-20
Participant Flow
Participant milestones
| Measure |
Midazolam
Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam
|
Ketamine
Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation
Baseline characteristics by cohort
| Measure |
Midazolam
n=34 Participants
Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam
|
Ketamine
n=33 Participants
Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.15 year
STANDARD_DEVIATION 1.40 • n=99 Participants
|
4.21 year
STANDARD_DEVIATION 1.32 • n=107 Participants
|
4.18 year
STANDARD_DEVIATION 1.35 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutesThe primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.
Outcome measures
| Measure |
Midazolam
n=34 Participants
Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam
|
Ketamine
n=33 Participants
Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
Ketamine: Preoperatively injected intravenous 1mg/kg ketamine
|
|---|---|---|
|
Emergence Agitation
|
6 participants
|
0 participants
|
Adverse Events
Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place