Trial Outcomes & Findings for Effectiveness and Feasibility of Patient Controlled Analgesia in the ED (NCT NCT01775371)
NCT ID: NCT01775371
Last Updated: 2020-12-04
Results Overview
Rate of Change in Numerical Rating Scale (NRS) of Pain per hour where 0 indicates "no pain", 10 indicates "worst possible pain" between 30 minutes and 120 minutes post-baseline i.e. NRS at 30 minutes minus NRS at 120 minutes post-baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
636 participants
Primary outcome timeframe
1.5 hours
Results posted on
2020-12-04
Participant Flow
Recruitment occurred from April 30, 2013 through February 25, 2016 in the Emergency Departments of three medical centers.
Participant milestones
| Measure |
Patient Controlled Analgesia
PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
|
Usual Care
Usual opioid analgesia determined by the provider
Usual Care: Usual opioid analgesia determined by the provider
|
|---|---|---|
|
Overall Study
STARTED
|
306
|
330
|
|
Overall Study
COMPLETED
|
306
|
330
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness and Feasibility of Patient Controlled Analgesia in the ED
Baseline characteristics by cohort
| Measure |
Patient Controlled Analgesia
n=306 Participants
PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
|
Usual Care
n=330 Participants
Usual opioid analgesia determined by the provider
Usual Care: Usual opioid analgesia determined by the provider
|
Total
n=636 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
|
306 Participants
n=5 Participants
|
330 Participants
n=7 Participants
|
636 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
|
180 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
382 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
179 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
384 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
69 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
36 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
306 participants
n=5 Participants
|
330 participants
n=7 Participants
|
636 participants
n=5 Participants
|
|
Location of pain
Abdomen
|
239 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
493 Participants
n=5 Participants
|
|
Location of pain
Other
|
67 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 3-6
|
6 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 7
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 8
|
47 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 9
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 10
|
167 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
336 Participants
n=5 Participants
|
|
Received non-opioid analgesics before arrival to Emergency Department
Yes
|
86 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Received non-opioid analgesics before arrival to Emergency Department
No
|
220 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
445 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.5 hoursPopulation: All patients enrolled
Rate of Change in Numerical Rating Scale (NRS) of Pain per hour where 0 indicates "no pain", 10 indicates "worst possible pain" between 30 minutes and 120 minutes post-baseline i.e. NRS at 30 minutes minus NRS at 120 minutes post-baseline.
Outcome measures
| Measure |
Patient Controlled Analgesia
n=306 Participants
PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
|
Usual Care
n=330 Participants
Usual opioid analgesia determined by the provider
Usual Care: Usual opioid analgesia determined by the provider
|
|---|---|---|
|
Rate of Change in Pain Intensity Per Hour
|
1.3 Score on a scale per hour
Interval 1.0 to 1.6
|
0.3 Score on a scale per hour
Interval 0.0 to 0.6
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: All patients
Number of participants with one or more adverse events defined by: oxygen saturation measured by pulse oximetry \< 92% for one minute or more, respiratory rate \<10 breaths/min counted for 60 seconds, or systolic blood pressure \< 90 mm Hg.
Outcome measures
| Measure |
Patient Controlled Analgesia
n=306 Participants
PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
|
Usual Care
n=330 Participants
Usual opioid analgesia determined by the provider
Usual Care: Usual opioid analgesia determined by the provider
|
|---|---|---|
|
Number of Participants With One or More Adverse Events
One or more adverse events
|
7 Participants
|
1 Participants
|
|
Number of Participants With One or More Adverse Events
No adverse events
|
299 Participants
|
329 Participants
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Patients with data at 120 minutes
Self report of satisfaction with treatment at120 minutes after baseline
Outcome measures
| Measure |
Patient Controlled Analgesia
n=281 Participants
PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
|
Usual Care
n=323 Participants
Usual opioid analgesia determined by the provider
Usual Care: Usual opioid analgesia determined by the provider
|
|---|---|---|
|
Patient Satisfaction With Pain Management
Satisfied
|
247 Participants
|
254 Participants
|
|
Patient Satisfaction With Pain Management
Dissatisfied or neutral
|
34 Participants
|
69 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursPopulation: All Registered Nurses
Single question about preference for PCA versus preference for conventional administration of IV opioids.
Outcome measures
| Measure |
Patient Controlled Analgesia
n=198 Participants
PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
|
Usual Care
Usual opioid analgesia determined by the provider
Usual Care: Usual opioid analgesia determined by the provider
|
|---|---|---|
|
Nurse Preference for PCA or Conventional Administration of IV Opioids
Prefer Usual Care
|
102 Participants
|
—
|
|
Nurse Preference for PCA or Conventional Administration of IV Opioids
No preference
|
56 Participants
|
—
|
|
Nurse Preference for PCA or Conventional Administration of IV Opioids
Prefer PCA
|
40 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hoursPopulation: All Physicians who entered one or more patients in each arm of the study
Single question about physician preference for PCA or conventional administration of IV opioids
Outcome measures
| Measure |
Patient Controlled Analgesia
n=143 Participants
PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
|
Usual Care
Usual opioid analgesia determined by the provider
Usual Care: Usual opioid analgesia determined by the provider
|
|---|---|---|
|
Physician Preference for PCA or Usual Care
Prefer Usual Care
|
25 Participants
|
—
|
|
Physician Preference for PCA or Usual Care
No Preference
|
49 Participants
|
—
|
|
Physician Preference for PCA or Usual Care
Prefer PCA
|
69 Participants
|
—
|
Adverse Events
Patient Controlled Analgesia
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patient Controlled Analgesia
n=306 participants at risk
PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
|
Usual Care
n=330 participants at risk
Usual opioid analgesia determined by the provider
Usual Care: Usual opioid analgesia determined by the provider
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
1.3%
4/306 • 2 hours
Need for oxygen supplementation or ventilatory assistance Hypotension requiring fluid administration or vasopressors Administration of naloxone (an opioid reversal agent) Oxygen saturation measured by pulse oximetry \< 92% for one minute or more Respiratory rate \<10 breaths/min counted for 60 seconds Systolic blood pressure \< 90 mm Hg.
|
0.00%
0/330 • 2 hours
Need for oxygen supplementation or ventilatory assistance Hypotension requiring fluid administration or vasopressors Administration of naloxone (an opioid reversal agent) Oxygen saturation measured by pulse oximetry \< 92% for one minute or more Respiratory rate \<10 breaths/min counted for 60 seconds Systolic blood pressure \< 90 mm Hg.
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen desaturation
|
0.98%
3/306 • 2 hours
Need for oxygen supplementation or ventilatory assistance Hypotension requiring fluid administration or vasopressors Administration of naloxone (an opioid reversal agent) Oxygen saturation measured by pulse oximetry \< 92% for one minute or more Respiratory rate \<10 breaths/min counted for 60 seconds Systolic blood pressure \< 90 mm Hg.
|
0.30%
1/330 • 2 hours
Need for oxygen supplementation or ventilatory assistance Hypotension requiring fluid administration or vasopressors Administration of naloxone (an opioid reversal agent) Oxygen saturation measured by pulse oximetry \< 92% for one minute or more Respiratory rate \<10 breaths/min counted for 60 seconds Systolic blood pressure \< 90 mm Hg.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place