Trial Outcomes & Findings for Comparing Intravenous Hydromorphone to Usual Care (NCT NCT01429298)
NCT ID: NCT01429298
Last Updated: 2018-05-18
Results Overview
Amount of patients who choose to forgo additional pain medication at 30 minutes post-baseline when asked the question, "Do you want more pain medication?"
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
350 participants
Primary outcome timeframe
30 minutes
Results posted on
2018-05-18
Participant Flow
Participant milestones
| Measure |
Hydromorphone
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes
|
Usual Care
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Usual care: Attending administers IV opioid of his choosing
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
175
|
|
Overall Study
Given IV Opioids
|
171
|
169
|
|
Overall Study
COMPLETED
|
171
|
169
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Hydromorphone
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes
|
Usual Care
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Usual care: Attending administers IV opioid of his choosing
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
6
|
Baseline Characteristics
Comparing Intravenous Hydromorphone to Usual Care
Baseline characteristics by cohort
| Measure |
Hydromorphone
n=164 Participants
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes
|
Usual Care
n=161 Participants
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Usual care: Attending administers IV opioid of his choosing
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
113 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
164 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
|
Weight
|
195.4 lbs
STANDARD_DEVIATION 39 • n=5 Participants
|
201.4 lbs
STANDARD_DEVIATION 42.8 • n=7 Participants
|
198.4 lbs
STANDARD_DEVIATION 41 • n=5 Participants
|
|
Location of Pain
Abdomen
|
101 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Location of Pain
Other
|
63 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Pain Intensity
Score of 3-7
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Pain Intensity
Score of 8
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Pain Intensity
Score of 9
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Pain Intensity
Score of 10
|
103 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Nauseated or vomited before receiving opioids in the ED
Yes
|
96 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Nauseated or vomited before receiving opioids in the ED
No
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Nauseated or vomited before receiving opioids in the ED
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
Amount of patients who choose to forgo additional pain medication at 30 minutes post-baseline when asked the question, "Do you want more pain medication?"
Outcome measures
| Measure |
Hydromorphone
n=164 Participants
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes
|
Usual Care
n=161 Participants
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Usual care: Attending administers IV opioid of his choosing
|
|---|---|---|
|
Number of Participants Who Declined Additional Medication at 30 Minutes
|
127 Participants
|
106 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
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 NRS score is calculated by subtracting the score at 30 minutes post treatment from the score at baseline, before treatment. The average of these values was calculated.
Outcome measures
| Measure |
Hydromorphone
n=164 Participants
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes
|
Usual Care
n=161 Participants
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Usual care: Attending administers IV opioid of his choosing
|
|---|---|---|
|
Mean Change in Pain Intensity Score From Baseline to 30 Minutes
|
6.7 units on a scale
Standard Deviation 2.9
|
5.6 units on a scale
Standard Deviation 3.2
|
POST_HOC outcome
Timeframe: 30 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
Outcome measures
| Measure |
Hydromorphone
n=164 Participants
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes
|
Usual Care
n=161 Participants
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Usual care: Attending administers IV opioid of his choosing
|
|---|---|---|
|
Number of Participants Who Achieved at Least 50% Decline in NRS Pain Score at 30 Minutes
|
136 Participants
|
111 Participants
|
POST_HOC outcome
Timeframe: 30 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
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=164 Participants
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes
|
Usual Care
n=161 Participants
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Usual care: Attending administers IV opioid of his choosing
|
|---|---|---|
|
Number of Patients Who Achieved Absolute Pain Intensity Score of 3 or Less at 30 Minutes
|
114 Participants
|
90 Participants
|
POST_HOC outcome
Timeframe: 30 minutesPopulation: The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
Outcome measures
| Measure |
Hydromorphone
n=164 Participants
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes
|
Usual Care
n=161 Participants
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Usual care: Attending administers IV opioid of his choosing
|
|---|---|---|
|
Number of Participants Who Reported no Pain or Mild Pain at 30 Minutes
|
122 Participants
|
95 Participants
|
Adverse Events
Hydromorphone
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydromorphone
n=164 participants at risk
2 mg of IV dilaudid will be administered over 2-3 minutes as initial dose.
2 mg IV hydromorphone: 2 mg IV hydromorphone over to 2-3 minutes
|
Usual Care
n=161 participants at risk
The attending physician administers whatever IV opioid he/she deems appropriate in whatever dose he/she chooses for initial dosing
Usual care: Attending administers IV opioid of his choosing
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oxygen Saturation <95%
|
0.00%
0/164 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
1.2%
2/161 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
|
Cardiac disorders
Heart Rate <50 beats/min
|
3.0%
5/164 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
2.5%
4/161 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
|
Vascular disorders
Systolic blood pressure <90 mmHg
|
1.8%
3/164 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
0.62%
1/161 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.3%
30/164 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
8.7%
14/161 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
|
Gastrointestinal disorders
Nausea
|
26.9%
18/67 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
14.5%
9/62 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
5/67 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
4.8%
3/62 • 30 minutes
The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)
|
Additional Information
Andrew Chang, MD, MS
Department of Emergency Medicine, Montefiore Medical Center
Phone: 718-920-7464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place