Pain
Conditions
Keywords
musculoskeletal pain, acetaminophen, ibuprofen
Brief summary
The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department.
Detailed description
The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department. We hypothesize that the combination will be more effective than either agent alone in patients presenting to the emergency department with acute pain from musculoskeletal injuries such as sprain, and bruises. While each agent alone is effective to some degree, many patients do not find complete relief with them and often narcotic agents (with all of their potential side effects) are added. In this study patients experiencing any pain will be randomly given either ibuprofen OR acetaminophen OR their combination and their degree of pain severity will be measured every 15 minutes up to one hour. At the end of this 1 hour patients still experiencing pain and requiring additional pain relief will receive additional analgesics at the discretion of their treating physician. We will not only measure how much the pain severity was reduced but also the percentage of patients that require some form of additional or rescue medication.
Interventions
DRUGIbuprofen
single dose
DRUGAcetaminophen
single dose
DRUGIbuprofen-acetaminophen combination
single dose
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment
Exclusion criteria
* Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity | 1 hour | Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Rescue Pain Relief | 1 hour | The need for additional analgesics |
Participant flow
Recruitment details
Patients were recruited from the emergency department over a 1 year period
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Ibuprofen 800 mg | 30 |
| Acetaminophen Acetaminophen 1 gm | 30 |
| Ibuprofen-acetaminophen Combination Ibuprofen 800 mg plus acetaminophen 1 gm | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | Acetaminophen | Ibuprofen-acetaminophen Combination | Ibuprofen | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 28 Participants | 28 Participants | 86 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 12 | 37 years STANDARD_DEVIATION 17 | 31 years STANDARD_DEVIATION 16 | 36 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 30 participants | 30 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 14 Participants | 41 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 16 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 30 | 0 / 30 | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Pain Severity
Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)
Time frame: 1 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ibuprofen | Pain Severity | 39 mm |
| Acetaminophen | Pain Severity | 43 mm |
| Ibuprofen-acetaminophen Combination | Pain Severity | 42 mm |
Secondary
Need for Rescue Pain Relief
The need for additional analgesics
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibuprofen | Need for Rescue Pain Relief | 11 participants |
| Acetaminophen | Need for Rescue Pain Relief | 10 participants |
| Ibuprofen-acetaminophen Combination | Need for Rescue Pain Relief | 5 participants |