Phase 2
N=600
Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)
Musculoskeletal Pain
Bottom Line
View on ClinicalTrials.gov: NCT03173456 ↗Enrolled (actual)
600
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline — 3.0; 3.0; 3.4; 3.1 Units on a scale — p=0.69
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oxycodone/APAP (Drug); hydrocodone/APAP (Drug); codeine/APAP (Drug); 400 ibuprofen/APAP (Drug); 800 ibuprofen/APAP (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline |
3.0; 3.0; 3.4; 3.1; 3.3 | 0.69 |
| SECONDARY Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline |
4.3; 4.6; 4.4; 4.5; 4.7 | 0.85 |
| SECONDARY Percentage of Patients Who Received Rescue Medication |
29; 28; 26; 27; 28 | 0.99 |
| SECONDARY Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain |
78; 83; 75; 89; 81 | — |
| SECONDARY Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication |
26; 37; 33; 34; 37 | 0.46 |
| SECONDARY Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication |
31; 44; 40; 51; 49 | 0.0501 |
Summary
This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain who present to the Emergency Department (ED).
Eligibility Criteria
Inclusion Criteria
- Patients ages 21 through 64 years of age
- Complaint of acute musculoskeletal pain in one or more extremity, defined as distal to and including the shoulder or hip joints.
- Pain of less than seven days duration
- Patient speaks Spanish or English
- The clinician plans to treat the patient in the ED with oral analgesics and is willing to treat the patient with opioid analgesics or up to 800 mg ibuprofen and 1000 mg acetaminophen
- Patient is going to receive imaging of the painful extremity
- Clinician judges patient to have capacity to provide informed consent
Exclusion Criteria
- Patient does not have cell phone or cannot receive a verification phone call on their cell phone while in the ED
- Any use of methadone currently or previously
- Chronic condition requiring frequent pain management such as arthritis, 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 24 hours
- Any other prescribed or over the counter topical or oral analgesics taken in past 24 hrs
- Pregnancy by either urine or serum human chorionic gonadotropin testing
- Breastfeeding per patient report
- History of peptic ulcer disease
- 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
- Lacerations,
- Multiple injuries
- 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, ritonavir, terbinafine, or St John's Wort
Data sourced from ClinicalTrials.gov (NCT03173456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.