Trial Outcomes & Findings for Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED) (NCT NCT03173456)
NCT ID: NCT03173456
Last Updated: 2022-02-01
Results Overview
Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10 = worse possible pain. Change calculated as NRS before medication administered (denoted as baseline) minus NRS 1-hour post-baseline. Higher scores mean more change which is the better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
600 participants
Primary outcome timeframe
Prior to Ingestion of study medication to one hour after ingestion of the study medication
Results posted on
2022-02-01
Participant Flow
Patients were recruited when they came into the ED with a complaint of pain. They were recruited in 2 academic EDs by trained, full-time, bilingual research associates from 11/26/2017 to 11/5/2019
Participant milestones
| Measure |
Oxycodone/Acetaminophen (APAP)
5 mg oxycodone + 325 mg acetaminophen
oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet
|
Hydrocodone/APAP
5 mg hydrocodone + 300 mg acetaminophen
hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
|
Codeine/APAP
30 mg codeine + 300 mg acetaminophen
codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet
|
400 Ibuprofen/APAP
400 mg ibuprofen + 1000 mg acetaminophen
400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet
|
800 Ibuprofen/APAP
800 mg ibuprofen + 1000 mg acetaminophen
800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
|
|---|---|---|---|---|---|
|
Baseline
STARTED
|
120
|
120
|
120
|
120
|
120
|
|
Baseline
COMPLETED
|
120
|
119
|
120
|
120
|
118
|
|
Baseline
NOT COMPLETED
|
0
|
1
|
0
|
0
|
2
|
|
2 Hour Follow-up
STARTED
|
120
|
119
|
120
|
120
|
118
|
|
2 Hour Follow-up
COMPLETED
|
120
|
118
|
119
|
119
|
116
|
|
2 Hour Follow-up
NOT COMPLETED
|
0
|
1
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Oxycodone/Acetaminophen (APAP)
5 mg oxycodone + 325 mg acetaminophen
oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet
|
Hydrocodone/APAP
5 mg hydrocodone + 300 mg acetaminophen
hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
|
Codeine/APAP
30 mg codeine + 300 mg acetaminophen
codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet
|
400 Ibuprofen/APAP
400 mg ibuprofen + 1000 mg acetaminophen
400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet
|
800 Ibuprofen/APAP
800 mg ibuprofen + 1000 mg acetaminophen
800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
|
|---|---|---|---|---|---|
|
Baseline
Medication dispensing system malfunction'
|
0
|
1
|
0
|
0
|
2
|
|
2 Hour Follow-up
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
2
|
Baseline Characteristics
Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)
Baseline characteristics by cohort
| Measure |
Oxycodone/APAP
n=120 Participants
5 mg oxycodone + 325 mg acetaminophen
oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet
|
Hydrocodone/APAP
n=119 Participants
5 mg hydrocodone + 300 mg acetaminophen
hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
|
Codeine/APAP
n=120 Participants
30 mg codeine + 300 mg acetaminophen
codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet
|
400 Ibuprofen/APAP
n=120 Participants
400 mg ibuprofen + 1000 mg acetaminophen
400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet
|
800 Ibuprofen/APAP
n=118 Participants
800 mg ibuprofen + 1000 mg acetaminophen
800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
|
Total
n=597 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 12 • n=5 Participants
|
39 years
STANDARD_DEVIATION 12 • n=7 Participants
|
38 years
STANDARD_DEVIATION 12 • n=5 Participants
|
36 years
STANDARD_DEVIATION 12 • n=4 Participants
|
38 years
STANDARD_DEVIATION 13 • n=21 Participants
|
37.4 years
STANDARD_DEVIATION 12 • n=10 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
265 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
332 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
79 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
313 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
281 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
215 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
219 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
147 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
119 participants
n=7 Participants
|
120 participants
n=5 Participants
|
120 participants
n=4 Participants
|
118 participants
n=21 Participants
|
597 participants
n=10 Participants
|
|
Initial pain intensity scale
0-6
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
|
Initial pain intensity scale
7
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
|
Initial pain intensity scale
8
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
99 Participants
n=10 Participants
|
|
Initial pain intensity scale
9
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
95 Participants
n=10 Participants
|
|
Initial pain intensity scale
10
|
66 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
338 Participants
n=10 Participants
|
|
Diagnosis
Sprain or Strain
|
75 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
371 Participants
n=10 Participants
|
|
Diagnosis
Extremity Fracture
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
87 Participants
n=10 Participants
|
|
Diagnosis
Muscle pain
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
66 Participants
n=10 Participants
|
|
Diagnosis
Contusion
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Diagnosis
Other
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
|
Non-Pharmacologic interventions
0
|
63 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
297 Participants
n=10 Participants
|
|
Non-Pharmacologic interventions
greater than or equal to 1
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
300 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Prior to Ingestion of study medication to one hour after ingestion of the study medicationPain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10 = worse possible pain. Change calculated as NRS before medication administered (denoted as baseline) minus NRS 1-hour post-baseline. Higher scores mean more change which is the better outcome.
Outcome measures
| Measure |
400 Ibuprofen/APAP
n=120 Participants
400 mg ibuprofen + 1000 mg acetaminophen
400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet
|
800 Ibuprofen/APAP
n=118 Participants
800 mg ibuprofen + 1000 mg acetaminophen
800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
|
Codeine/APAP
n=120 Participants
30 mg codeine + 300 mg acetaminophen
codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet
|
Hydrocodone/APAP
n=119 Participants
5 mg hydrocodone + 300 mg acetaminophen
hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
|
Oxycodone/APAP
n=120 Participants
5 mg oxycodone + 325 mg acetaminophen
oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet
|
|---|---|---|---|---|---|
|
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline
|
3.0 Units on a scale
Interval 2.6 to 3.5
|
3.0 Units on a scale
Interval 2.5 to 3.5
|
3.4 Units on a scale
Interval 2.9 to 3.9
|
3.1 Units on a scale
Interval 2.7 to 3.5
|
3.3 Units on a scale
Interval 2.8 to 3.7
|
SECONDARY outcome
Timeframe: Prior to ingestion of study medication to 2 hours after ingestion of the study medicationPopulation: Differences between population at 1 hour and 2 hour is due to patients leaving the Emergency Department before 2 hours post-baseline
Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10=worst possible pain. Change is calculated as Numerical Rating Scale before medication is administered (denoted as baseline) minus NRS 2- hours past baseline. Higher numbers indicate better outcomes.
Outcome measures
| Measure |
400 Ibuprofen/APAP
n=119 Participants
400 mg ibuprofen + 1000 mg acetaminophen
400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet
|
800 Ibuprofen/APAP
n=116 Participants
800 mg ibuprofen + 1000 mg acetaminophen
800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
|
Codeine/APAP
n=119 Participants
30 mg codeine + 300 mg acetaminophen
codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet
|
Hydrocodone/APAP
n=117 Participants
5 mg hydrocodone + 300 mg acetaminophen
hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
|
Oxycodone/APAP
n=120 Participants
5 mg oxycodone + 325 mg acetaminophen
oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet
|
|---|---|---|---|---|---|
|
Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline
|
4.3 units on a scale
Interval 3.9 to 4.8
|
4.6 units on a scale
Interval 4.1 to 5.1
|
4.4 units on a scale
Interval 3.9 to 4.9
|
4.5 units on a scale
Interval 4.1 to 5.0
|
4.7 units on a scale
Interval 4.2 to 5.2
|
SECONDARY outcome
Timeframe: Entire two-hour time periodNumber of patients who received additional analgesics divided by total number of patients x 100
Outcome measures
| Measure |
400 Ibuprofen/APAP
n=119 Participants
400 mg ibuprofen + 1000 mg acetaminophen
400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet
|
800 Ibuprofen/APAP
n=116 Participants
800 mg ibuprofen + 1000 mg acetaminophen
800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
|
Codeine/APAP
n=119 Participants
30 mg codeine + 300 mg acetaminophen
codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet
|
Hydrocodone/APAP
n=118 Participants
5 mg hydrocodone + 300 mg acetaminophen
hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
|
Oxycodone/APAP
n=120 Participants
5 mg oxycodone + 325 mg acetaminophen
oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet
|
|---|---|---|---|---|---|
|
Percentage of Patients Who Received Rescue Medication
|
29 Participants
|
28 Participants
|
26 Participants
|
27 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: End of two-hour time periodPopulation: Missing data: 1 from codeine/APAP arm, 1 from hydrocodone/APAP arm, 2 from oxycodone/APAP arm
Number of patients who would choose to take study medication again divided by number of patients x 100. Question asked at end of two-hour time period
Outcome measures
| Measure |
400 Ibuprofen/APAP
n=119 Participants
400 mg ibuprofen + 1000 mg acetaminophen
400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet
|
800 Ibuprofen/APAP
n=116 Participants
800 mg ibuprofen + 1000 mg acetaminophen
800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
|
Codeine/APAP
n=118 Participants
30 mg codeine + 300 mg acetaminophen
codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet
|
Hydrocodone/APAP
n=117 Participants
5 mg hydrocodone + 300 mg acetaminophen
hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
|
Oxycodone/APAP
n=118 Participants
5 mg oxycodone + 325 mg acetaminophen
oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet
|
|---|---|---|---|---|---|
|
Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain
|
78 Participants
|
83 Participants
|
75 Participants
|
89 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: From time of ingestion of study medication to one hour laterNumber of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100
Outcome measures
| Measure |
400 Ibuprofen/APAP
n=120 Participants
400 mg ibuprofen + 1000 mg acetaminophen
400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet
|
800 Ibuprofen/APAP
n=118 Participants
800 mg ibuprofen + 1000 mg acetaminophen
800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
|
Codeine/APAP
n=120 Participants
30 mg codeine + 300 mg acetaminophen
codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet
|
Hydrocodone/APAP
n=119 Participants
5 mg hydrocodone + 300 mg acetaminophen
hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
|
Oxycodone/APAP
n=120 Participants
5 mg oxycodone + 325 mg acetaminophen
oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet
|
|---|---|---|---|---|---|
|
Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication
|
26 Participants
|
37 Participants
|
33 Participants
|
34 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: From time of ingestion of study medication to two hours laterNumber of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100
Outcome measures
| Measure |
400 Ibuprofen/APAP
n=120 Participants
400 mg ibuprofen + 1000 mg acetaminophen
400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet
|
800 Ibuprofen/APAP
n=118 Participants
800 mg ibuprofen + 1000 mg acetaminophen
800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
|
Codeine/APAP
n=120 Participants
30 mg codeine + 300 mg acetaminophen
codeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet
|
Hydrocodone/APAP
n=119 Participants
5 mg hydrocodone + 300 mg acetaminophen
hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
|
Oxycodone/APAP
n=120 Participants
5 mg oxycodone + 325 mg acetaminophen
oxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet
|
|---|---|---|---|---|---|
|
Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication
|
31 Participants
|
44 Participants
|
40 Participants
|
51 Participants
|
49 Participants
|
Adverse Events
400 Ibuprofen/APAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
800 Ibuprofen/APAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Codeine/APAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydrocodone/APAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxycodone/APAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Polly Bijur
Department of Emergency Medicine Albert Einstein Coll of Med
Phone: 914-661-4707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place