Trial Outcomes & Findings for IV Acetaminophen as an Analgesic Adjunct (NCT NCT02621619)
NCT ID: NCT02621619
Last Updated: 2018-11-08
Results Overview
Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline \[e.g. Change = NRS(baseline) - NRS(60 min)\]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
159 participants
Primary outcome timeframe
baseline and 60 minutes after medication was infused
Results posted on
2018-11-08
Participant Flow
Participant milestones
| Measure |
IV Acetaminophen + 0.5 mg IV Hydromorphone
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
Placebo + 0.5 mg IV Hydromorphone
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
79
|
|
Overall Study
COMPLETED
|
80
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IV Acetaminophen as an Analgesic Adjunct
Baseline characteristics by cohort
| Measure |
IV Acetaminophen + 0.5 mg IV Hydromorphone
n=80 Participants
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
Placebo + 0.5 mg IV Hydromorphone
n=79 Participants
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
72 years
n=7 Participants
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
79 participants
n=7 Participants
|
159 participants
n=5 Participants
|
|
Baseline Pain intensity
5-7
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Baseline Pain intensity
8
|
14 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Baseline Pain intensity
9
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Baseline Pain intensity
10
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Number of patients nauseated before receiving study medication
Yes - Nauseated
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Number of patients nauseated before receiving study medication
No - not nauseated
|
46 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Number of patients vomited before receiving study medication
Yes - Vomited
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Number of patients vomited before receiving study medication
No - Did not vomit
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 60 minutes after medication was infusedPain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline \[e.g. Change = NRS(baseline) - NRS(60 min)\]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given.
Outcome measures
| Measure |
IV Acetaminophen + 0.5 mg IV Hydromorphone
n=80 Participants
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
Placebo + 0.5 mg IV Hydromorphone
n=79 Participants
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
|---|---|---|
|
Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
|
5.8 units on a scale
Standard Deviation 3.2
|
5.2 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: baseline to 5 min, 15 min, 30 min, and 45 minutesPain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline \[e.g. Change = NRS(baseline) - NRS(15 min)\]. Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes
Outcome measures
| Measure |
IV Acetaminophen + 0.5 mg IV Hydromorphone
n=80 Participants
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
Placebo + 0.5 mg IV Hydromorphone
n=79 Participants
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
|---|---|---|
|
Change in Pain Intensity Over Time
Baseline to 45 minutes
|
5.5 units on a scale
Standard Deviation 2.9
|
5.2 units on a scale
Standard Deviation 2.8
|
|
Change in Pain Intensity Over Time
Baseline to 5 minutes
|
3.4 units on a scale
Standard Deviation 2.8
|
2.9 units on a scale
Standard Deviation 2.4
|
|
Change in Pain Intensity Over Time
Baseline to 15 minutes
|
4.7 units on a scale
Standard Deviation 3.1
|
4.0 units on a scale
Standard Deviation 2.6
|
|
Change in Pain Intensity Over Time
Baseline to 30 minutes
|
5.1 units on a scale
Standard Deviation 2.9
|
4.8 units on a scale
Standard Deviation 2.6
|
Adverse Events
IV Acetaminophen + 0.5 mg IV Hydromorphone
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo + 0.5 mg IV Hydromorphone
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IV Acetaminophen + 0.5 mg IV Hydromorphone
n=80 participants at risk
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
Placebo + 0.5 mg IV Hydromorphone
n=79 participants at risk
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
17.4%
8/46 • 60 minutes
|
19.5%
8/41 • 60 minutes
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
2/46 • 60 minutes
|
2.4%
1/41 • 60 minutes
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
4/80 • 60 minutes
|
1.3%
1/79 • 60 minutes
|
|
Cardiac disorders
Heart rate < 50 beats/min
|
1.2%
1/80 • 60 minutes
|
0.00%
0/79 • 60 minutes
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen saturation < 95%
|
1.2%
1/80 • 60 minutes
|
2.5%
2/79 • 60 minutes
|
|
Vascular disorders
Systolic blood pressure < 90 mmHg
|
0.00%
0/80 • 60 minutes
|
1.3%
1/79 • 60 minutes
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place