Trial Outcomes & Findings for Safety and Efficacy of Intravenous Hydromorphone in Elderly Emergency Department Patients With Acute Severe Pain (NCT NCT01429285)
NCT ID: NCT01429285
Last Updated: 2018-05-18
Results Overview
Number of patients with "successful treatment" is defined as the number of patients who declined additional pain medication within 1 hour of study entry when asked the question, "Do you want more pain medication?". This measure looks at declining pain medication at either 15 minutes or 60 minutes, whereas 4. Post-Hoc refers only to the answer to the question at the 60 minute mark post-baseline.
COMPLETED
PHASE4
350 participants
1 hour
2018-05-18
Participant Flow
Participant milestones
| Measure |
Hydromorphone
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
175
|
|
Overall Study
Given IV Opioids
|
166
|
171
|
|
Overall Study
Completed Primary Outcome Data
|
161
|
168
|
|
Overall Study
Confirmation of no Duplicate Enrollment
|
153
|
166
|
|
Overall Study
COMPLETED
|
153
|
166
|
|
Overall Study
NOT COMPLETED
|
22
|
9
|
Reasons for withdrawal
| Measure |
Hydromorphone
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Overall Study
Protocol Violation
|
9
|
4
|
|
Overall Study
Missing Data
|
5
|
3
|
|
Overall Study
Erroneously Enrolled Twice
|
8
|
2
|
Baseline Characteristics
Safety and Efficacy of Intravenous Hydromorphone in Elderly Emergency Department Patients With Acute Severe Pain
Baseline characteristics by cohort
| Measure |
Hydromorphone
n=153 Participants
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
n=166 Participants
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
Total
n=319 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75 years
STANDARD_DEVIATION 7 • n=99 Participants
|
74 years
STANDARD_DEVIATION 6 • n=107 Participants
|
74 years
STANDARD_DEVIATION 6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
97 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
35 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
153 Participants
n=99 Participants
|
166 Participants
n=107 Participants
|
319 Participants
n=206 Participants
|
|
Weight
|
162 lbs
STANDARD_DEVIATION 33 • n=99 Participants
|
165 lbs
STANDARD_DEVIATION 38 • n=107 Participants
|
164 lbs
STANDARD_DEVIATION 36 • n=206 Participants
|
|
Diagnosis
Non-specific abdominal pain
|
50 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Diagnosis
Musculoskeletal pain
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Diagnosis
Back pain
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Diagnosis
Colitis/diverticulitis
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Diagnosis
Small Bowel Obstruction
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Diagnosis
Extremity fracture
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Diagnosis
biliary colic/cholecystitis
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Diagnosis
Kidney stone/pyelonephritis
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Diagnosis
Appendicitis
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Diagnosis
Other (pancreatitis, perforated viscus, etc)
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Pain Intensity
NRS = 3-6
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Pain Intensity
NRS = 7
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Pain Intensity
NRS = 8
|
31 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Pain Intensity
NRS = 9
|
20 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Pain Intensity
NRS = 10
|
76 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
|
Nauseated or vomited before receiving opioids in the ED
Yes
|
65 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Nauseated or vomited before receiving opioids in the ED
No
|
87 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
176 Participants
n=206 Participants
|
|
Nauseated or vomited before receiving opioids in the ED
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Number of patients with "successful treatment" is defined as the number of patients who declined additional pain medication within 1 hour of study entry when asked the question, "Do you want more pain medication?". This measure looks at declining pain medication at either 15 minutes or 60 minutes, whereas 4. Post-Hoc refers only to the answer to the question at the 60 minute mark post-baseline.
Outcome measures
| Measure |
Hydromorphone
n=153 Participants
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
n=166 Participants
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Number of Patients With Successful Treatment
Achieved satisfactory analgesia within 60 min
|
127 Participants
|
137 Participants
|
|
Number of Patients With Successful Treatment
No satisfactory analgesia within 60 min
|
26 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable"). The change in scores over time is calculated by subtracting the score at 60 minutes from the score at baseline (before treatment). These change values were then averaged.
Outcome measures
| Measure |
Hydromorphone
n=153 Participants
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
n=166 Participants
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Mean Change in Pain Intensity From Baseline to 60 Minutes
|
5.4 units on a scale
Standard Deviation 2.9
|
5.2 units on a scale
Standard Deviation 3.1
|
POST_HOC outcome
Timeframe: 15 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Satisfactory Analgesia is defined as declining additional pain medication when asked the question, "Do you want more pain medication?"
Outcome measures
| Measure |
Hydromorphone
n=153 Participants
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
n=166 Participants
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Number of Patients Who Achieved Satisfactory Analgesia at 15 Minutes Post-baseline
|
89 Participants
|
111 Participants
|
POST_HOC outcome
Timeframe: 60 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
"Satisfactory analgesia" is defined as the patient declining additional pain medication when asked the question, "Do you want more pain medication?". This measure refers only to the answer to this question asked at the 60 minute mark. The Primary Outcome (1. Primary Outcome - Number of Patients with successful treatment) refers to the answering "no" to this question at 15 minutes or 60 minutes post-baseline.
Outcome measures
| Measure |
Hydromorphone
n=153 Participants
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
n=166 Participants
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Number of Patients Who Achieved Satisfactory Analgesia at 60 Minutes Post-baseline
|
111 Participants
|
119 Participants
|
POST_HOC outcome
Timeframe: 60 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable"). The 50% or greater change in pain score is measured by subtracting the pain score at 60 minutes from the pain score at baseline, then dividing that value by the original baseline value and multiplying by 100% to get a percent change value.
Outcome measures
| Measure |
Hydromorphone
n=153 Participants
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
n=166 Participants
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Number of Patients With 50% or Greater Decline in Pain Intensity Score From Baseline to 60 Minutes
|
106 Participants
|
107 Participants
|
POST_HOC outcome
Timeframe: 60 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable").
Outcome measures
| Measure |
Hydromorphone
n=153 Participants
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
n=166 Participants
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Number of Patients With a Pain Intensity Score of 3 or Less at 60 Minutes
|
83 Participants
|
87 Participants
|
POST_HOC outcome
Timeframe: 60 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable").
Outcome measures
| Measure |
Hydromorphone
n=153 Participants
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
n=166 Participants
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Pain Intensity Score at 60 Minutes
|
3 units on a scale
Interval 0.0 to 5.0
|
3 units on a scale
Interval 0.0 to 6.0
|
Adverse Events
Hydromorphone
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydromorphone
n=153 participants at risk
Hydromorphone protocol
Hydromorphone: 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
|
Usual Care
n=166 participants at risk
Usual care
Usual care: Attending administers any IV opioid in any dose he chooses
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oxygen saturation <95%
|
4.6%
7/153 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
7.8%
13/166 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
|
Vascular disorders
Systolic blood pressure <90 mmHg
|
2.6%
4/153 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
1.2%
2/166 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
2/153 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
4.8%
8/166 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
|
Gastrointestinal disorders
Nausea
|
11.5%
10/87 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
6.7%
6/89 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
4/87 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
3.4%
3/89 • 60 minutes
The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)
|
Additional Information
Andrew Chang, MD, MS
Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place