Trial Outcomes & Findings for Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome (NCT NCT02094352)
NCT ID: NCT02094352
Last Updated: 2018-01-31
Results Overview
Evidence of changes in NRS pain scores between baseline and six months post infusion
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
6 months post infusion
Results posted on
2018-01-31
Participant Flow
Participant milestones
| Measure |
Ketamine Infusion + Epidural Infusion + Booster Infusion
Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three ketamine booster infusions over the course of three months.
Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months.
|
Control Group + Epidural Infusion + Booster Infusion
Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three saline booster infusions over the course of three months.
Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome
Baseline characteristics by cohort
| Measure |
Ketamine Infusion + Epidural Infusion + Booster Infusion
n=2 Participants
Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three ketamine booster infusions over the course of three months.
Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months.
|
Control Group + Epidural Infusion + Booster Infusion
n=1 Participants
Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three saline booster infusions over the course of three months.
Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months.
|
Total
n=3 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post infusionPopulation: Study terminated early due to lack of enrollment. We did not analyze any data.
Evidence of changes in NRS pain scores between baseline and six months post infusion
Outcome measures
Outcome data not reported
Adverse Events
Ketamine Infusion + Epidural Infusion + Booster Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group + Epidural Infusion + Booster Infusion
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