Trial Outcomes & Findings for Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED (NCT NCT03521102)
NCT ID: NCT03521102
Last Updated: 2023-03-02
Results Overview
Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of \>=1.3 points on the 0-10 scale.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
162 participants
Primary outcome timeframe
60 minutes following administration of medication
Results posted on
2023-03-02
Participant Flow
Enrollment began in August 2018, paused between March and June 2020, and concluded in October 2021. A total of 2,363 patients were screened for participation of which 162 were enrolled from two urban emergency departments in Bronx, NY.
Participant milestones
| Measure |
Acetaminophen 1000mg IV
Acetaminophen 1000mg IV: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push.
|
Hydromorphone 0.5mg IV
Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
|
Overall Study
COMPLETED
|
81
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acetaminophen 1000mg IV
n=81 Participants
Acetaminophen 1000mg IV: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push.
|
Hydromorphone 0.5mg IV
n=81 Participants
Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75 years
STANDARD_DEVIATION 8 • n=81 Participants
|
74 years
STANDARD_DEVIATION 6 • n=81 Participants
|
75 years
STANDARD_DEVIATION 7 • n=162 Participants
|
|
Age, Customized
60-69 years old
|
23 Participants
n=81 Participants
|
22 Participants
n=81 Participants
|
45 Participants
n=162 Participants
|
|
Age, Customized
70-79 years old
|
40 Participants
n=81 Participants
|
45 Participants
n=81 Participants
|
85 Participants
n=162 Participants
|
|
Age, Customized
80-89 years old
|
12 Participants
n=81 Participants
|
14 Participants
n=81 Participants
|
26 Participants
n=162 Participants
|
|
Age, Customized
>=90 years old
|
6 Participants
n=81 Participants
|
0 Participants
n=81 Participants
|
6 Participants
n=162 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=81 Participants
|
51 Participants
n=81 Participants
|
107 Participants
n=162 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=81 Participants
|
30 Participants
n=81 Participants
|
55 Participants
n=162 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
81 participants
n=81 Participants
|
81 participants
n=81 Participants
|
162 participants
n=162 Participants
|
|
Duration of Pain
|
2 Minutes
n=81 Participants
|
2 Minutes
n=81 Participants
|
2 Minutes
n=162 Participants
|
|
NRS Pain Score (0-10)
|
10 score on a scale
n=81 Participants
|
10 score on a scale
n=81 Participants
|
10 score on a scale
n=162 Participants
|
|
Location of Pain
Abdomen/Flank/Pelvis
|
52 Participants
n=81 Participants
|
55 Participants
n=81 Participants
|
107 Participants
n=162 Participants
|
|
Location of Pain
Back/Neck
|
6 Participants
n=81 Participants
|
7 Participants
n=81 Participants
|
13 Participants
n=162 Participants
|
|
Location of Pain
Chest
|
1 Participants
n=81 Participants
|
6 Participants
n=81 Participants
|
7 Participants
n=162 Participants
|
|
Location of Pain
Extremity
|
21 Participants
n=81 Participants
|
11 Participants
n=81 Participants
|
32 Participants
n=162 Participants
|
|
Location of Pain
Head
|
0 Participants
n=81 Participants
|
2 Participants
n=81 Participants
|
2 Participants
n=162 Participants
|
|
Location of Pain
Widespread
|
1 Participants
n=81 Participants
|
0 Participants
n=81 Participants
|
1 Participants
n=162 Participants
|
PRIMARY outcome
Timeframe: 60 minutes following administration of medicationPain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of \>=1.3 points on the 0-10 scale.
Outcome measures
| Measure |
Acetaminophen 1000mg IV
n=81 Participants
Acetaminophen 1000mg IV: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push.
|
Hydromorphone 0.5mg IV
n=81 Participants
Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push.
|
|---|---|---|
|
Clinical Improvement in NRS Pain Score
|
62 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 120 minutes following administration of medicationPopulation: Study participants did not receive any additional medication before the assessment of the primary outcome.
Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course.
Outcome measures
| Measure |
Acetaminophen 1000mg IV
n=81 Participants
Acetaminophen 1000mg IV: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push.
|
Hydromorphone 0.5mg IV
n=81 Participants
Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push.
|
|---|---|---|
|
Need for Rescue Medication
|
37 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 60 minutes after administration of medicationPopulation: Study participants did not receive any additional medication before the assessment of the primary outcome.
The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes.
Outcome measures
| Measure |
Acetaminophen 1000mg IV
n=81 Participants
Acetaminophen 1000mg IV: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push.
|
Hydromorphone 0.5mg IV
n=81 Participants
Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push.
|
|---|---|---|
|
Improvement in NPS Pain Score by >=50%
|
30 Participants
|
43 Participants
|
Adverse Events
Acetaminophen 1000mg IV
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Hydromorphone 0.5mg IV
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acetaminophen 1000mg IV
n=81 participants at risk
Acetaminophen 1000mg IV: 1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push.
|
Hydromorphone 0.5mg IV
n=81 participants at risk
Hydromorphone 0.5 mg IV: 100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in solution with 2mL of normal saline, administered as a slow intravenous push.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/81 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
4.9%
4/81 • Number of events 4 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
|
Nervous system disorders
Drowsiness
|
2.5%
2/81 • Number of events 2 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
0.00%
0/81 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
|
Nervous system disorders
Headache
|
2.5%
2/81 • Number of events 2 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
1.2%
1/81 • Number of events 1 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/81 • Number of events 1 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
4.9%
4/81 • Number of events 4 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
|
General disorders
Discomfort NEC
|
1.2%
1/81 • Number of events 1 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
1.2%
1/81 • Number of events 1 • Participants were queried for the emergence of new symptoms after receipt of the investigational medication. Affirmative responses were followed with an open-ended question eliciting details regarding side effects 30 and 60 minutes after medication administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place