Trial Outcomes & Findings for Effect of Perioperative i.v. Low-dose S(+) Ketamine (NCT NCT00354029)
NCT ID: NCT00354029
Last Updated: 2011-07-20
Results Overview
The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
24 hours
Results posted on
2011-07-20
Participant Flow
Participant milestones
| Measure |
S (+) Ketamine
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
40
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
S (+) Ketamine
|
Placebo
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
2
|
Baseline Characteristics
Effect of Perioperative i.v. Low-dose S(+) Ketamine
Baseline characteristics by cohort
| Measure |
S (+) Ketamine
n=43 Participants
|
Placebo
n=40 Participants
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
46.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
48 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
43 participants
n=5 Participants
|
40 participants
n=7 Participants
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.
Outcome measures
| Measure |
S (+) Ketamine
n=43 Participants
|
Placebo
n=40 Participants
|
|---|---|---|
|
NRS Pain = Numeric Rating Scale (0-10)
|
1.6 Units on a scale
Standard Deviation 2.1
|
1.5 Units on a scale
Standard Deviation 1.7
|
Adverse Events
S (+) Ketamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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