Trial Outcomes & Findings for Does a Single Intravenous Dose of Ketamine Reduce the Need for Supplemental Opioids in Post-Cesarean Section Patients? (NCT NCT00486902)
NCT ID: NCT00486902
Last Updated: 2014-04-14
Results Overview
Request for oral hydrocodone/acetaminophen for pain not controlled by around the clock non-steroidal antiflammatory drugs in the first 24 hours following cesarean delivery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
188 participants
Primary outcome timeframe
24 hours
Results posted on
2014-04-14
Participant Flow
The trial was conducted at Prentice Women's Hospital between August 2006 and November 2006.
188 subjects were recruited for the study. 5 subjects in the ketamine group and 3 in the saline group were excluded after randomization but before study drug administration.
Participant milestones
| Measure |
Ketamine
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
94
|
|
Overall Study
COMPLETED
|
85
|
89
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Ketamine
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
decision for postpartum tubal ligation
|
3
|
1
|
|
Overall Study
spinal anesthetic protocal violation
|
1
|
1
|
|
Overall Study
Did not meet inclusion criteria
|
1
|
0
|
|
Overall Study
No toradol due to hemmorhage or allergy
|
3
|
1
|
Baseline Characteristics
Does a Single Intravenous Dose of Ketamine Reduce the Need for Supplemental Opioids in Post-Cesarean Section Patients?
Baseline characteristics by cohort
| Measure |
Ketamine
n=94 Participants
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=94 Participants
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
188 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 3 • n=93 Participants
|
34 years
STANDARD_DEVIATION 3 • n=4 Participants
|
34 years
STANDARD_DEVIATION 3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
188 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
176 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=93 Participants
|
94 participants
n=4 Participants
|
188 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Analysis was performed per protocol
Request for oral hydrocodone/acetaminophen for pain not controlled by around the clock non-steroidal antiflammatory drugs in the first 24 hours following cesarean delivery.
Outcome measures
| Measure |
Ketamine
n=85 Participants
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=89 Participants
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Number of Subjects Requiring Supplemental Analgesia in the First 24 Hours Following Cesarean Delivery
|
64 participants
|
66 participants
|
SECONDARY outcome
Timeframe: 24 hoursNumeric rating of pain scores (NRS) scale (0 to 10) at time of supplemental analgesia request. Zero is no pain and 10 is worst pain imaginable.
Outcome measures
| Measure |
Ketamine
n=85 Participants
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=89 Participants
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Verbal Pain Scores (0 to 10) at First Analgesia Request
|
3 Scores on a scale
Interval 2.0 to 4.0
|
4 Scores on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Analysis was per protocol
Cumulative hydrocodone/acetaminophen for supplemental analgesia to treat breakthrough pain for 72 hours following cesarean delivery
Outcome measures
| Measure |
Ketamine
n=85 Participants
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=89 Participants
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Cumulative Hydrocodone/Acetaminophen for Supplemental Analgesia to Treat Breakthrough Pain
|
10 tablets
Interval 6.0 to 14.0
|
9 tablets
Interval 5.0 to 12.0
|
SECONDARY outcome
Timeframe: 24 hoursNumber of subjects reporting nausea in first 24 hours following cesarean delivery
Outcome measures
| Measure |
Ketamine
n=85 Participants
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=89 Participants
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Postoperative Nausea
|
27 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 24 hoursNumber of subjects that vomited in the first 24 hours following cesarean delivery
Outcome measures
| Measure |
Ketamine
n=85 Participants
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=89 Participants
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Postoperative Vomiting
|
13 participants
|
13 participants
|
SECONDARY outcome
Timeframe: 24 hoursNumber of subjects with pruritus in the first 24 hours following cesarean delivery
Outcome measures
| Measure |
Ketamine
n=85 Participants
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=89 Participants
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Postperative Pruritus
|
12 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 72 hoursNumber of subject reporting disturbing dreams at 72 hours post cesarean delivery
Outcome measures
| Measure |
Ketamine
n=85 Participants
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=89 Participants
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Disturbing Dreams
|
0 participants
|
0 participants
|
POST_HOC outcome
Timeframe: 2 weeksNumeric rating for pain score (0 to 10) reported at 2 weeks following cesarean delivery. Zero is no pain and 10 is worst pain imaginable.
Outcome measures
| Measure |
Ketamine
n=85 Participants
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=89 Participants
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Pain Score (0-10) at 2 Weeks Following Cesarean Delivery
|
2 Scores on a scale
Interval 1.0 to 3.0
|
2.6 Scores on a scale
Interval 1.0 to 4.0
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine
n=85 participants at risk
Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
|
Placebo
n=89 participants at risk
Subjects receive IV Saline 20 mL 5 minutes after infant delivery
|
|---|---|---|
|
Psychiatric disorders
Spontaneous complaint of psycho-mimetic reaction
|
35.3%
30/85 • Number of events 30
|
7.9%
7/89 • Number of events 7
|
Additional Information
Dr. Robert J. McCarthy
Northwestern University Feinberg School of Medicine
Phone: 312-926-9015
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place