Trial Outcomes & Findings for Ketamine Patient-Controlled Analgesia for Acute Pain (NCT NCT02062879)
NCT ID: NCT02062879
Last Updated: 2017-09-21
Results Overview
Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
Participants will be followed for their entire hospital stay, an expected average of 1 week.
Results posted on
2017-09-21
Participant Flow
Participant milestones
| Measure |
Ketamine
Ketamine 90mg/30 mL PCA (3 mg/mL)
Ketamine: Ketamine administered as patient-controlled analgesia.
|
Hydromorphone
Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Ketamine
Ketamine 90mg/30 mL PCA (3 mg/mL)
Ketamine: Ketamine administered as patient-controlled analgesia.
|
Hydromorphone
Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
Ketamine Patient-Controlled Analgesia for Acute Pain
Baseline characteristics by cohort
| Measure |
Ketamine
n=10 Participants
Ketamine 90mg/30 mL PCA (3 mg/mL)
Ketamine: Ketamine administered as patient-controlled analgesia.
|
Hydromorphone
n=10 Participants
Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=99 Participants
|
26 years
n=107 Participants
|
30 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
BMI
|
27 kg/m^2
n=99 Participants
|
26.5 kg/m^2
n=107 Participants
|
27 kg/m^2
n=206 Participants
|
|
Injury Severity Score
|
29 scores on a scale
n=99 Participants
|
28 scores on a scale
n=107 Participants
|
29 scores on a scale
n=206 Participants
|
|
Blunt Trauma
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Penetrating Trauma
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 week.Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents
Outcome measures
| Measure |
Ketamine
n=10 Participants
Ketamine 90mg/30 mL PCA (3 mg/mL)
Ketamine: Ketamine administered as patient-controlled analgesia.
|
Hydromorphone
n=10 Participants
Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
|
|---|---|---|
|
Total Daily Opioid Requirement
|
10 mg morphine equivalents/day
Interval 4.2 to 15.0
|
42.5 mg morphine equivalents/day
Interval 31.7 to 62.0
|
SECONDARY outcome
Timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 weekBreakthrough daily opioid requirement in milligrams of morphine equivalents/day
Outcome measures
| Measure |
Ketamine
n=10 Participants
Ketamine 90mg/30 mL PCA (3 mg/mL)
Ketamine: Ketamine administered as patient-controlled analgesia.
|
Hydromorphone
n=10 Participants
Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
|
|---|---|---|
|
Breakthrough Daily Opioid Requirement
|
10 mg morphine equivalents/day
Interval 0.63 to 19.38
|
10 mg morphine equivalents/day
Interval 4.38 to 22.5
|
SECONDARY outcome
Timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 weekMedian daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.
Outcome measures
| Measure |
Ketamine
n=10 Participants
Ketamine 90mg/30 mL PCA (3 mg/mL)
Ketamine: Ketamine administered as patient-controlled analgesia.
|
Hydromorphone
n=10 Participants
Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
|
|---|---|---|
|
Median Pain Score
|
6.3 scores on a scale
Interval 4.0 to 7.5
|
5.3 scores on a scale
Interval 3.0 to 6.8
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Hydromorphone
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 |
Ketamine
n=10 participants at risk
Ketamine 90mg/30 mL PCA (3 mg/mL)
Ketamine: Ketamine administered as patient-controlled analgesia.
|
Hydromorphone
n=10 participants at risk
Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)
Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
|
|---|---|---|
|
Psychiatric disorders
Hallucinations
|
40.0%
4/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10
|
30.0%
3/10
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/10
|
40.0%
4/10
|
Additional Information
Sheila Takieddine
UC Health University of Cincinnati Medical Center
Phone: 513-585-6195
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place