Trial Outcomes & Findings for Comparing Ketamine and Morphine in the Treatment of Acute Fracture Pain (NCT NCT02430818)
NCT ID: NCT02430818
Last Updated: 2019-05-22
Results Overview
Study outcomes involve change in participants' pain as measured by a visual analog scale. The scale is a 10 inch line from 0 to 10 inches with 10 being the most pain and 0 being no pain. There are no units on the scale; it is just a straight line from no pain (0) to the worst pain (10). We assessed at o, 15, and 60 minutes but only scored the VAS at 60 minutes.
TERMINATED
NA
13 participants
At 0 minutes and 60 minutes
2019-05-22
Participant Flow
Participant milestones
| Measure |
Ketamine
Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).
ketamine
|
Morphine
Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).
morphine
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Ketamine and Morphine in the Treatment of Acute Fracture Pain
Baseline characteristics by cohort
| Measure |
Ketamine
n=7 Participants
Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).
ketamine
|
Morphine
n=6 Participants
Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).
morphine
|
Total
n=13 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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
37 years
n=5 Participants
|
46 years
n=7 Participants
|
41 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 0 minutes and 60 minutesStudy outcomes involve change in participants' pain as measured by a visual analog scale. The scale is a 10 inch line from 0 to 10 inches with 10 being the most pain and 0 being no pain. There are no units on the scale; it is just a straight line from no pain (0) to the worst pain (10). We assessed at o, 15, and 60 minutes but only scored the VAS at 60 minutes.
Outcome measures
| Measure |
Ketamine
n=6 Participants
We asked patients if they would use the study medication again for acute pain.
|
Morphine
n=4 Participants
We asked patients if they would use the study medication again for acute pain.
|
|---|---|---|
|
Pain Treatment-VAS (Visual Analog Scale)
|
4 score on a scale
Standard Deviation 1.3
|
4 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: We will include the number of patients with adverse events. Given the very small sample size and small number of events, we are just including total numbers.
We will monitor for adverse effects and record for changes in vital signs including nausea and vomiting, hypotension, respiratory depression, laryngospasm, and emotional and psychological effects (emergence reactions).
Outcome measures
| Measure |
Ketamine
n=6 Participants
We asked patients if they would use the study medication again for acute pain.
|
Morphine
n=4 Participants
We asked patients if they would use the study medication again for acute pain.
|
|---|---|---|
|
Number of Participants With an Adverse Effects
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: We describe all patients that received medication. One patient randomized to morphine did not receive any study medication as her pain improved after being splinted to the extent that she did not have any pain. Two patients were screened and did not meet criteria for inclusion. We used simple, descriptive statistics.
Patients will be assessed to determine whether the participant would consider using the drug given to them for pain relief in the future. It was measured on a likert scale from 1-5 with 1 being did not like and would not use the drug again to 5 being like and would definitely receive the medication again. There are no units. The numbers below are the total number of patients that completed this answer. This was only asked on patients that received medication as if they did not receive medication the answer would not make sense. The median value is the likert value on a scale of 1-5 with the standard deviation.
Outcome measures
| Measure |
Ketamine
n=7 Participants
We asked patients if they would use the study medication again for acute pain.
|
Morphine
n=5 Participants
We asked patients if they would use the study medication again for acute pain.
|
|---|---|---|
|
Would the Participant Would Consider Using the Drug Given to Them for Pain Relief in the Future
|
4 units on a scale
Standard Deviation 1.3
|
4 units on a scale
Standard Deviation 1.8
|
Adverse Events
Ketamine
Morphine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine
n=7 participants at risk
Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).
ketamine
|
Morphine
n=6 participants at risk
Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).
morphine
|
|---|---|---|
|
Nervous system disorders
emergence reaction
|
14.3%
1/7 • Number of events 1 • Patients will be monitored for 60 minutes for adverse events from the study medication.
|
16.7%
1/6 • Number of events 1 • Patients will be monitored for 60 minutes for adverse events from the study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place