Trial Outcomes & Findings for Intra-operative Ketamine Infusions in Opioid-dependent Patients With Chronic Lower Back Pain (NCT NCT00899600)
NCT ID: NCT00899600
Last Updated: 2018-10-18
Results Overview
Total morphine(mg)consumed at 48 hours.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
48 hours
Results posted on
2018-10-18
Participant Flow
The study was conducted over a two-year period (February 2007 to April 2009) at Dartmouth-Hitchcock Medical Center. Approval was obtained from the Committee for Protection of Human Subjects (Lebanon, NH, United States of America). Informed patient consent was obtained from all patients.
Three hundred and one patients were screened. Of these patients, 165 (55%) were eligible for enrollment. Sixty-one percent of eligible patients were randomized to one of the two treatment groups. No patients enrolled in the study were excluded from the primary analysis.
Participant milestones
| Measure |
Normal Saline
Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
|
Ketamine
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
|
Overall Study
COMPLETED
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intra-operative Ketamine Infusions in Opioid-dependent Patients With Chronic Lower Back Pain
Baseline characteristics by cohort
| Measure |
Normal Saline
n=50 Participants
Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
|
Ketamine
n=52 Participants
|
Total
n=102 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
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
51.6 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
52 participants
n=7 Participants
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: See methodology
Total morphine(mg)consumed at 48 hours.
Outcome measures
| Measure |
Normal Saline
n=50 Participants
Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
|
Ketamine
n=52 Participants
Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
|
|---|---|---|
|
Morphine Consumption in the First 48 Hours After Surgery
|
309 mg
Standard Deviation 341
|
195 mg
Standard Deviation 111
|
SECONDARY outcome
Timeframe: Discharge from hospital, approximately 2 days after surgeryOutcome measures
| Measure |
Normal Saline
n=50 Participants
Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
|
Ketamine
n=52 Participants
Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
|
|---|---|---|
|
Hospital Duration
|
4571 minutes
Standard Deviation 4099
|
4364 minutes
Standard Deviation 2296
|
SECONDARY outcome
Timeframe: Baseline, Inoperative (approximately) 48 hoursPopulation: Analysis included only a subgroup of participants who had not used non-steroidals (NSAIDS).
Hemodynamic change (Heart Rate) from baseline in the intraoperative and 48-h postoperative periods
Outcome measures
| Measure |
Normal Saline
n=47 Participants
Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
|
Ketamine
n=37 Participants
Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
|
|---|---|---|
|
Hemodynamic Changes - Heart Rate
Baseline Peak Heart Rate
|
77.3 beats per minute
Standard Deviation 13.5
|
74 beats per minute
Standard Deviation 13.9
|
|
Hemodynamic Changes - Heart Rate
Interoperative Peak Heart Rate
|
91.4 beats per minute
Standard Deviation 13.67
|
87.6 beats per minute
Standard Deviation 13.72
|
|
Hemodynamic Changes - Heart Rate
48-hours Post Operative
|
98.6 beats per minute
Standard Deviation 13.4
|
99.8 beats per minute
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: Baseline, Inoperative (approximately) 48 hoursPopulation: Analysis included only a subgroup of participants who had not used non-steroidals (NSAIDS).
Hemodynamic change (Blood Pressure) from baseline in the intraoperative and 48-h postoperative periods
Outcome measures
| Measure |
Normal Saline
n=47 Participants
Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
|
Ketamine
n=37 Participants
Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
|
|---|---|---|
|
Hemodynamic Changes - Blood Pressure
Baseline systolic blood pressure
|
133.8 mmHg
Standard Deviation 19.5
|
132.2 mmHg
Standard Deviation 16.9
|
|
Hemodynamic Changes - Blood Pressure
Baseline diatolic blood pressure
|
81.3 mmHg
Standard Deviation 12.8
|
77.3 mmHg
Standard Deviation 11.3
|
|
Hemodynamic Changes - Blood Pressure
Interoperative Systolic blood pressure
|
139.6 mmHg
Standard Deviation 16.7
|
139.9 mmHg
Standard Deviation 18.3
|
|
Hemodynamic Changes - Blood Pressure
Interoperative diastolic blood pressure
|
80.8 mmHg
Standard Deviation 13.2
|
77.8 mmHg
Standard Deviation 13.7
|
|
Hemodynamic Changes - Blood Pressure
48-hours post operative systolic blood pressure
|
133 mmHg
Standard Deviation 16.4
|
129.7 mmHg
Standard Deviation 12.2
|
|
Hemodynamic Changes - Blood Pressure
48-hours post operative diastolic blood pressure
|
75.9 mmHg
Standard Deviation 8.9
|
75.6 mmHg
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 48 hours and 6 weeksAdverse events
Outcome measures
| Measure |
Normal Saline
n=50 Participants
Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
|
Ketamine
n=52 Participants
Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
|
|---|---|---|
|
Percentage of Participants With Complications/Adverse Events
Nausea, 48 hours
|
22.5 Percent
|
26.9 Percent
|
|
Percentage of Participants With Complications/Adverse Events
Vomiting, 48 hours
|
12.2 Percent
|
15.4 Percent
|
|
Percentage of Participants With Complications/Adverse Events
Hallucinations, 48 hours
|
2.0 Percent
|
1.9 Percent
|
|
Percentage of Participants With Complications/Adverse Events
Urinary Retention, 48 hours
|
2.0 Percent
|
7.7 Percent
|
|
Percentage of Participants With Complications/Adverse Events
Nausea, 6 weeks
|
17.0 Percent
|
11.8 Percent
|
|
Percentage of Participants With Complications/Adverse Events
Vomiting, 6 weeks
|
8.5 Percent
|
9.8 Percent
|
|
Percentage of Participants With Complications/Adverse Events
Hallucinations, 6 weeks
|
23.4 Percent
|
11.8 Percent
|
|
Percentage of Participants With Complications/Adverse Events
Urinary Retention, 6 weeks
|
57.5 Percent
|
45.1 Percent
|
Adverse Events
Normal Saline
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ketamine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Saline
n=50 participants at risk
Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
|
Ketamine
n=52 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/vomiting during the hospital admission as reported at the 6-wk f/u visit.
|
8.0%
4/50 • Number of events 4
|
9.6%
5/52 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place