Trial Outcomes & Findings for Low Dose Peri-operative IV Ketamine for Chronic Post-surgery Pain Prevention (NCT NCT01296347)
NCT ID: NCT01296347
Last Updated: 2019-09-04
Results Overview
Measures in pain include: Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine'
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
6 weeks after surgery
Results posted on
2019-09-04
Participant Flow
Participant milestones
| Measure |
Saline
Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
|
Ketamine
Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
|
|---|---|---|
|
Allocation
STARTED
|
38
|
39
|
|
Allocation
COMPLETED
|
35
|
35
|
|
Allocation
NOT COMPLETED
|
3
|
4
|
|
6 Week Follow up
STARTED
|
35
|
35
|
|
6 Week Follow up
COMPLETED
|
35
|
34
|
|
6 Week Follow up
NOT COMPLETED
|
0
|
1
|
|
3 Month Follow up
STARTED
|
35
|
34
|
|
3 Month Follow up
COMPLETED
|
34
|
33
|
|
3 Month Follow up
NOT COMPLETED
|
1
|
1
|
|
6 Month Follow up
STARTED
|
34
|
33
|
|
6 Month Follow up
COMPLETED
|
32
|
31
|
|
6 Month Follow up
NOT COMPLETED
|
2
|
2
|
|
12 Month Follow up
STARTED
|
32
|
31
|
|
12 Month Follow up
COMPLETED
|
28
|
28
|
|
12 Month Follow up
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Saline
Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
|
Ketamine
Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
|
|---|---|---|
|
Allocation
Withdrawal by Subject
|
1
|
2
|
|
Allocation
Lack of Efficacy
|
1
|
2
|
|
Allocation
not received infusion
|
1
|
0
|
|
6 Week Follow up
Death
|
0
|
1
|
|
3 Month Follow up
Death
|
1
|
0
|
|
3 Month Follow up
Lost to Follow-up
|
0
|
1
|
|
6 Month Follow up
Death
|
2
|
1
|
|
6 Month Follow up
Lost to Follow-up
|
0
|
1
|
|
12 Month Follow up
Lost to Follow-up
|
3
|
1
|
|
12 Month Follow up
Death
|
1
|
1
|
|
12 Month Follow up
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Low Dose Peri-operative IV Ketamine for Chronic Post-surgery Pain Prevention
Baseline characteristics by cohort
| Measure |
Saline
n=35 Participants
Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
|
Ketamine
n=35 Participants
Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=99 Participants
|
61 years
n=107 Participants
|
64.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
35 participants
n=99 Participants
|
35 participants
n=107 Participants
|
70 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after surgeryPopulation: Ketamine group one participant did not have data
Measures in pain include: Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine'
Outcome measures
| Measure |
Saline
n=35 Participants
Patients received a placebo infusion of 0.9% sodium chloride, which started 10 minutes prior to the start of the operation and continued for 96 hours.
|
Ketamine
n=34 Participants
Patients received intravenous ketamine, starting 10 minutes prior to surgery and continued for 96 hours
|
|---|---|---|
|
Pain Score on Moving at 6 Weeks
|
0 units on a scale
Interval 0.0 to 0.0
|
1.5 units on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 6 weeks, 3 month, 6 monthPopulation: Participant who experienced pain.
Analgesia consumption will be measured post-operatively and at 6 weeks
Outcome measures
| Measure |
Saline
n=18 Participants
Patients received a placebo infusion of 0.9% sodium chloride, which started 10 minutes prior to the start of the operation and continued for 96 hours.
|
Ketamine
n=18 Participants
Patients received intravenous ketamine, starting 10 minutes prior to surgery and continued for 96 hours
|
|---|---|---|
|
Analgesic Consumption (Opioid)
6 months
|
34 mg
Interval 34.0 to 34.0
|
9 mg
Interval 9.0 to 9.0
|
|
Analgesic Consumption (Opioid)
6 weeks
|
9 mg
Interval 0.0 to 26.0
|
0 mg
Interval 0.0 to 21.0
|
|
Analgesic Consumption (Opioid)
3 months
|
21 mg
Interval 9.0 to 47.0
|
17 mg
Interval 17.0 to 17.0
|
SECONDARY outcome
Timeframe: 6 weeks, 6 months, 12 monthsHypoaesthesia: light touch of the blunt end of a paintbrush was felt less precisely, than in healthy tissue. Hyperalgesia: the pain induced by a sterile neurotip, applied perpendicular to the skin is felt abnormally strongly, in comparison to the contralateral side. Static allodynia: the application of a Von Frey hair number 14. (8g) was unpleasant, in comparison to the contralateral side. Dynamic allodynia: three successive gentle strokes of an 8 mm-wide paintbrush over a 40 mm distance, is unpleasant, in comparison to the contralateral side.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 108 hoursThe presence of nausea recorded at the above time points
Outcome measures
| Measure |
Saline
n=35 Participants
Patients received a placebo infusion of 0.9% sodium chloride, which started 10 minutes prior to the start of the operation and continued for 96 hours.
|
Ketamine
n=35 Participants
Patients received intravenous ketamine, starting 10 minutes prior to surgery and continued for 96 hours
|
|---|---|---|
|
Incidence of Side-effects, Nausea
|
14 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 108 hoursThe presence of vomiting recorded at the above time points
Outcome measures
| Measure |
Saline
n=35 Participants
Patients received a placebo infusion of 0.9% sodium chloride, which started 10 minutes prior to the start of the operation and continued for 96 hours.
|
Ketamine
n=35 Participants
Patients received intravenous ketamine, starting 10 minutes prior to surgery and continued for 96 hours
|
|---|---|---|
|
Incidence of Side Effect, Vomiting
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 108 hoursThe presence of lightheaded recorded at the above time points
Outcome measures
| Measure |
Saline
n=35 Participants
Patients received a placebo infusion of 0.9% sodium chloride, which started 10 minutes prior to the start of the operation and continued for 96 hours.
|
Ketamine
n=35 Participants
Patients received intravenous ketamine, starting 10 minutes prior to surgery and continued for 96 hours
|
|---|---|---|
|
Incidence of Side Effect, Lightheaded
|
5 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 108 hoursThe presence of vivid dreams recorded at the above time points
Outcome measures
| Measure |
Saline
n=35 Participants
Patients received a placebo infusion of 0.9% sodium chloride, which started 10 minutes prior to the start of the operation and continued for 96 hours.
|
Ketamine
n=35 Participants
Patients received intravenous ketamine, starting 10 minutes prior to surgery and continued for 96 hours
|
|---|---|---|
|
Incidence of Side Effect, Vivid Dreams
|
2 Participants
|
13 Participants
|
Adverse Events
Saline
Serious events: 8 serious events
Other events: 34 other events
Deaths: 0 deaths
Ketamine
Serious events: 9 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saline
n=38 participants at risk
Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
|
Ketamine
n=39 participants at risk
Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
|
|---|---|---|
|
Cardiac disorders
cardiac arrest
|
2.6%
1/38 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
0.00%
0/39 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Cardiac disorders
Hypotension
|
0.00%
0/38 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
2.6%
1/39 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
7.9%
3/38 • Number of events 3 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
2.6%
1/39 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/38 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
2.6%
1/39 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/38 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
2.6%
1/39 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Lung hypoinflation
|
0.00%
0/38 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
2.6%
1/39 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/38 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
2.6%
1/39 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord paralysis
|
0.00%
0/38 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
2.6%
1/39 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Eye disorders
Hallucination, visual
|
5.3%
2/38 • Number of events 2 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
5.1%
2/39 • Number of events 2 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Psychiatric disorders
Confusion postoperative
|
0.00%
0/38 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
0.00%
0/39 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Psychiatric disorders
Agitation postoperative
|
2.6%
1/38 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
0.00%
0/39 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Renal and urinary disorders
Renal failure
|
2.6%
1/38 • Number of events 1 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
0.00%
0/39 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
Other adverse events
| Measure |
Saline
n=38 participants at risk
Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
|
Ketamine
n=39 participants at risk
Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours
Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
13.2%
5/38 • Number of events 8 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
35.9%
14/39 • Number of events 21 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Nervous system disorders
Vivid dreams
|
5.3%
2/38 • Number of events 2 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
33.3%
13/39 • Number of events 13 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Gastrointestinal disorders
Nausea
|
36.8%
14/38 • Number of events 14 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
43.6%
17/39 • Number of events 17 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Gastrointestinal disorders
Vomiting
|
21.1%
8/38 • Number of events 8 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
20.5%
8/39 • Number of events 8 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
34.2%
13/38 • Number of events 13 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
30.8%
12/39 • Number of events 12 • 1 year
For 108 hours the ketamine or placebo infusion was running and whilst the patient remained in hospital after surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place