Trial Outcomes & Findings for Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department (NCT NCT00910208)
NCT ID: NCT00910208
Last Updated: 2019-12-27
Results Overview
Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
211 participants
Primary outcome timeframe
Baseline and 30 minutes post treatment
Results posted on
2019-12-27
Participant Flow
Recruitment started April 3, 2009 and ended June 30, 2010. Patients were recruited by bilingual research associates in the Emergency Department of Jacobi Medical Center, Bronx, NY
Participant milestones
| Measure |
PCA 1 mg Demand Dose
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dose every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
|---|---|---|---|
|
Overall Study
STARTED
|
69
|
72
|
70
|
|
Overall Study
COMPLETED
|
67
|
70
|
69
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
Baseline characteristics by cohort
| Measure |
PCA 1 mg Demand Dose
n=67 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
n=70 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
n=69 Participants
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 10 • n=5 Participants
|
38 years
STANDARD_DEVIATION 12 • n=7 Participants
|
37 years
STANDARD_DEVIATION 12 • n=5 Participants
|
36 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
41 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American - not Hispanic
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - not Hispanic
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian/other
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Initial Pain Score
Pain Score less than 7
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Initial Pain Score
Pain Score=7
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Initial Pain Score
Pain Score=8
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Initial Pain Score
Pain Score=9
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Initial Pain Score
Pain Score=10
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 30 minutes post treatmentParticipants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline.
Outcome measures
| Measure |
PCA 1 mg Demand Dose
n=67 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
n=70 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
n=69 Participants
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
|---|---|---|---|
|
Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale
|
3.8 Units on a scale
Interval 3.0 to 4.6
|
4.0 Units on a scale
Interval 3.3 to 4.6
|
3.6 Units on a scale
Interval 2.9 to 4.4
|
PRIMARY outcome
Timeframe: 30 minutes post treatmentPain Intensity measured on Likert Scale. Participants self report pain level according to the scale by selecting from No relief, Slight relief, Moderate relief, A lot of relief, and Complete relief)
Outcome measures
| Measure |
PCA 1 mg Demand Dose
n=67 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
n=70 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
n=69 Participants
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
|---|---|---|---|
|
Participants With Short Term Efficacy: Pain Relief by 30 Minutes
No relief
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Participants With Short Term Efficacy: Pain Relief by 30 Minutes
Slight relief
|
14 Participants
|
10 Participants
|
16 Participants
|
|
Participants With Short Term Efficacy: Pain Relief by 30 Minutes
Moderate relief
|
18 Participants
|
20 Participants
|
12 Participants
|
|
Participants With Short Term Efficacy: Pain Relief by 30 Minutes
A lot of relief
|
24 Participants
|
31 Participants
|
25 Participants
|
|
Participants With Short Term Efficacy: Pain Relief by 30 Minutes
Complete relief
|
7 Participants
|
5 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Baseline, 30, 60, 90, 120 post-treatmentParticipants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain Total analgesia is measured by a summary of change in pain that varies from 0 - no change to
Outcome measures
| Measure |
PCA 1 mg Demand Dose
n=67 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
n=70 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
n=69 Participants
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
|---|---|---|---|
|
Long Term Efficacy: Total Analgesia Provided Over 2 Hours
|
-16.4 scores on a scale *minutes
Interval -18.8 to -14.1
|
-17.4 scores on a scale *minutes
Interval -19.7 to -15.1
|
-13.6 scores on a scale *minutes
Interval -15.9 to -11.3
|
PRIMARY outcome
Timeframe: 120 minutesParticipants aksed to and give range
Outcome measures
| Measure |
PCA 1 mg Demand Dose
n=65 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
n=69 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
n=68 Participants
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
|---|---|---|---|
|
Long Term Efficacy: Pain Relief by 120 Minutes
No relief
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Long Term Efficacy: Pain Relief by 120 Minutes
Slight relief
|
9 Participants
|
5 Participants
|
18 Participants
|
|
Long Term Efficacy: Pain Relief by 120 Minutes
Moderate relief
|
9 Participants
|
8 Participants
|
13 Participants
|
|
Long Term Efficacy: Pain Relief by 120 Minutes
A lot of relief
|
22 Participants
|
34 Participants
|
16 Participants
|
|
Long Term Efficacy: Pain Relief by 120 Minutes
Complete relief
|
18 Participants
|
16 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 2 hoursAdverse Events defined as: oxygen saturation \< 92%; respiratory rate \<10 breaths/min; systolic blood pressure \< 90 mm Hg)
Outcome measures
| Measure |
PCA 1 mg Demand Dose
n=67 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
n=70 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
n=69 Participants
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
|---|---|---|---|
|
Safety: Incidence of Adverse Events
No Adverse events
|
67 Participants
|
69 Participants
|
68 Participants
|
|
Safety: Incidence of Adverse Events
1 or more adverse events
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 hours post treatmentcount of participants who needed or did not needed additional analgesia
Outcome measures
| Measure |
PCA 1 mg Demand Dose
n=67 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
n=70 Participants
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
n=69 Participants
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
|---|---|---|---|
|
Need for Supplementary Analgesia
Needed supplementary medication
|
4 Participants
|
0 Participants
|
20 Participants
|
|
Need for Supplementary Analgesia
Did not need supplementary medication
|
63 Participants
|
70 Participants
|
49 Participants
|
Adverse Events
PCA 1 mg Demand Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PCA 1.5 mg Demand Dose
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-PCA Comparison Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCA 1 mg Demand Dose
n=67 participants at risk
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
n=70 participants at risk
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
n=69 participants at risk
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Transient Oxygen Desaturation as measured by pulse oximetry
|
0.00%
0/67 • Up to 8 hours
|
1.4%
1/70 • Number of events 1 • Up to 8 hours
|
0.00%
0/69 • Up to 8 hours
|
|
Cardiac disorders
Transient decrease in blood pressure
|
0.00%
0/67 • Up to 8 hours
|
0.00%
0/70 • Up to 8 hours
|
1.4%
1/69 • Number of events 1 • Up to 8 hours
|
Other adverse events
| Measure |
PCA 1 mg Demand Dose
n=67 participants at risk
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
PCA 1.5 mg Demand Dose
n=70 participants at risk
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine
|
Non-PCA Comparison Group
n=69 participants at risk
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine
|
|---|---|---|---|
|
Nervous system disorders
Sedation
|
1.5%
1/67 • Number of events 1 • Up to 8 hours
|
0.00%
0/70 • Up to 8 hours
|
0.00%
0/69 • Up to 8 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place