Pain
Conditions
Keywords
pain
Brief summary
The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.
Detailed description
To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows: 1. Oxycodone/acetaminophen (5/325) 2. Hydrocodone/acetaminophen (5/325) 3. Codeine/acetaminophen (30/300) 4. Ibuprofen/acetaminophen (400/1000)
Interventions
DRUGCodeine/acetaminophen
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Complaint of acute pain of \< 7 days duration * Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities; * Radiologic evaluation is planned
Exclusion criteria
* Inability to confirm reliable means of phone followup. * Past use of methadone * Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy * History of an adverse reaction to any of the study medications * Opioids taken in the past 24 hours * Ibuprofen or acetaminophen taken in past 8 hours * Pregnancy by either urine or serum HCG testing * Breastfeeding per patient report * History of peptic ulcer disease * Report of any prior use of recreational narcotics * Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease * Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 2 hours | Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 1 hour | Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxycodone/Acetaminophen Oxycodone/acetaminophen (5 mg/325 mg)
Oxycodone/acetaminophen | 104 |
| Hydrocodone/Acetaminophen Hydrocodone/acetaminophen (5 mg/300 mg)
Hydrocodone/acetaminophen | 103 |
| Codeine/Acetaminophen Codeine/acetaminophen (30 mg/300 mg)
Codeine/acetaminophen | 103 |
| Ibuprofen/Acetaminophen Ibuprofen/acetaminophen (400 mg/1000 mg)
Ibuprofen/acetaminophen | 101 |
| Total | 411 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Oxycodone/Acetaminophen | Hydrocodone/Acetaminophen | Codeine/Acetaminophen | Ibuprofen/Acetaminophen | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 12 | 37 years STANDARD_DEVIATION 13 | 37 years STANDARD_DEVIATION 12 | 37 years STANDARD_DEVIATION 11 | 37 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized African-American | 29 Participants | 26 Participants | 33 Participants | 34 Participants | 122 Participants |
| Race/Ethnicity, Customized Caucasian | 7 Participants | 8 Participants | 6 Participants | 2 Participants | 23 Participants |
| Race/Ethnicity, Customized East Asian/Asian | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized Latino | 62 Participants | 65 Participants | 58 Participants | 62 Participants | 247 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 1 Participants | 3 Participants | 0 Participants | 8 Participants |
| Region of Enrollment United States | 104 participants | 103 participants | 103 participants | 101 participants | 411 participants |
| Sex: Female, Male Female | 50 Participants | 51 Participants | 44 Participants | 54 Participants | 199 Participants |
| Sex: Female, Male Male | 54 Participants | 52 Participants | 59 Participants | 47 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxycodone/Acetaminophen | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 4.4 units on a scale |
| Hydrocodone/Acetaminophen | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 3.5 units on a scale |
| Codeine/Acetaminophen | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 3.9 units on a scale |
| Ibuprofen/Acetaminophen | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 4.3 units on a scale |
Secondary
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxycodone/Acetaminophen | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 3.1 units on a scale |
| Hydrocodone/Acetaminophen | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 2.4 units on a scale |
| Codeine/Acetaminophen | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 2.7 units on a scale |
| Ibuprofen/Acetaminophen | Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | 2.9 units on a scale |