Trial Outcomes & Findings for Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain (NCT NCT00305058)
NCT ID: NCT00305058
Last Updated: 2018-08-20
Results Overview
Pain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
194 participants
Primary outcome timeframe
Baseline to 30 minutes after medication infused
Results posted on
2018-08-20
Participant Flow
Participant milestones
| Measure |
Morphine
0.05 mg/kg IV morphine
|
Hydromorphone
0.0075 mg/kg IV hydromorphone
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
97
|
|
Overall Study
Inclusion/Exclusion Verification
|
96
|
97
|
|
Overall Study
All Outcome Data Collected
|
93
|
95
|
|
Overall Study
Data Collection Forms Filed for Analysis
|
90
|
93
|
|
Overall Study
COMPLETED
|
90
|
93
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Morphine
0.05 mg/kg IV morphine
|
Hydromorphone
0.0075 mg/kg IV hydromorphone
|
|---|---|---|
|
Overall Study
Participant too young
|
1
|
0
|
|
Overall Study
Missing data collection instrument
|
3
|
2
|
|
Overall Study
Missing outcome data
|
3
|
2
|
Baseline Characteristics
Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain
Baseline characteristics by cohort
| Measure |
Morphine
n=90 Participants
0.05 mg/kg IV morphine
|
Hydromorphone
n=93 Participants
0.0075 mg/kg IV hydromorphone
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 8 • n=99 Participants
|
74 years
STANDARD_DEVIATION 8 • n=107 Participants
|
75 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
39 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
90 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Weight
|
148 lbs
STANDARD_DEVIATION 29 • n=99 Participants
|
157 lbs
STANDARD_DEVIATION 29 • n=107 Participants
|
153 lbs
STANDARD_DEVIATION 29 • n=206 Participants
|
|
Primary Language
English
|
51 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Primary Language
Spanish
|
33 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Primary Language
Other
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Primary Language
Unknown
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Baseline Pain Score
6
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Baseline Pain Score
7
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Baseline Pain Score
8
|
20 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Baseline Pain Score
9
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Baseline Pain Score
10
|
40 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Number of participants who took analgesics before coming to the ED
None
|
66 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Number of participants who took analgesics before coming to the ED
Some
|
24 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Number of participants who had pain in specific locations
Abdomen/pelvis
|
45 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Number of participants who had pain in specific locations
Extremities
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Number of participants who had pain in specific locations
Back
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Number of participants who had pain in specific locations
Chest
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Number of participants who had pain in specific locations
Head/neck
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Number of participants who had pain in specific locations
Other
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Number of participants who had pain in specific locations
Unknown/missing data
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of participants experiencing nausea since pain began
No
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Number of participants experiencing nausea since pain began
Yes
|
41 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Number of participants experiencing vomiting since pain began
No
|
59 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Number of participants experiencing vomiting since pain began
Yes
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 30 minutes after medication infusedPain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused
Outcome measures
| Measure |
Morphine
n=90 Participants
0.05 mg/kg IV morphine
|
Hydromorphone
n=93 Participants
0.0075 mg/kg IV hydromorphone
|
|---|---|---|
|
Change in Pain Intensity
|
3.3 units on a scale
Standard Deviation 2.5
|
3.8 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline to 30 minutes after medication infusedPain score is a measure of pain intensity using the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Data is separated into two groups: those with greater than or equal to 50% change in their pain score and those with less than 50% change in their pain score.
Outcome measures
| Measure |
Morphine
n=90 Participants
0.05 mg/kg IV morphine
|
Hydromorphone
n=93 Participants
0.0075 mg/kg IV hydromorphone
|
|---|---|---|
|
Number of Participants With a Change in Pain Score
less than 50% decrease
|
53 Participants
|
53 Participants
|
|
Number of Participants With a Change in Pain Score
greater than or equal to 50% decrease
|
37 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 30 minutes after medication infusedPain relief here is a subjective measure indicated by the following categories: No, Slight, Moderate, and Complete. Participants were asked to pick the category that best fit their level of pain relief 30 minutes after medication was infused.
Outcome measures
| Measure |
Morphine
n=90 Participants
0.05 mg/kg IV morphine
|
Hydromorphone
n=93 Participants
0.0075 mg/kg IV hydromorphone
|
|---|---|---|
|
Number of Participants With Pain Relief
none or slight
|
37 Participants
|
32 Participants
|
|
Number of Participants With Pain Relief
moderate to complete
|
53 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: 30 minutes after medication infusedNumber of participants who were satisfied with pain medication received, based on their response of good to excellent or poor to fair. Participants were asked to pick which response best fit their satisfaction with the pain medication they received 30 minutes after that medication was infused "Good to Excellent" or "Poor to fair".
Outcome measures
| Measure |
Morphine
n=90 Participants
0.05 mg/kg IV morphine
|
Hydromorphone
n=93 Participants
0.0075 mg/kg IV hydromorphone
|
|---|---|---|
|
Number of Participants Satisfied With Pain Medication
Good to excellent
|
56 Participants
|
59 Participants
|
|
Number of Participants Satisfied With Pain Medication
Poor to fair
|
34 Participants
|
34 Participants
|
Adverse Events
Morphine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Hydromorphone
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Morphine
n=90 participants at risk
0.05 mg/kg IV morphine
|
Hydromorphone
n=93 participants at risk
0.0075 mg/kg IV hydromorphone
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.7%
4/46 • 120 minutes
|
10.4%
5/48 • 120 minutes
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • 120 minutes
|
0.00%
0/48 • 120 minutes
|
|
Vascular disorders
Systolic blood pressure <90 mmHg
|
1.1%
1/90 • 120 minutes
|
3.2%
3/93 • 120 minutes
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/90 • 120 minutes
|
4.3%
4/93 • 120 minutes
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory rate <12 breaths/min
|
0.00%
0/90 • 120 minutes
|
1.1%
1/93 • 120 minutes
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen saturation <90%
|
3.3%
3/90 • 120 minutes
|
1.1%
1/93 • 120 minutes
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen saturation 90%-94%
|
5.6%
5/90 • 120 minutes
|
9.7%
9/93 • 120 minutes
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place