Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)

Brief 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).
Brief Title
Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)
Detailed Description
The optimal treatment of musculoskeletal extremity pain in the ED not known. The study is a randomized controlled trial designed to compare 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. The primary outcome is the between treatment group difference in change in patients' rating of pain intensity one hour after ingestion of the study medication. Secondary outcomes include: 1) the between treatment group difference in change in patients' rating of pain intensity two hours after ingestion of the study medication; 2) difference in proportion of patients who receive rescue medication; 3) difference in proportion of patients who would choose to take the study medication again if they returned to the ED with similar pain; 4) difference in proportion of patients who experience side effects.
Completion Date
Completion Date Type
Actual
Conditions
Musculoskeletal Pain
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
Inclusion 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

Gender
All
Gender Based
false
Keywords
acute pain
musculoskeletal pain
emergency medicine
Emergency Service, Hospital
analgesics
Acetaminophen
Ibuprofen
oxycodone
hydrocodone
codeine
adult
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
64 Years
Minimum Age
21 Years
NCT Id
NCT03173456
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2016-7322
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline
Outcome Time Frame
Prior to Ingestion of study medication to one hour after ingestion of the study medication
Secondary Outcomes
Outcome Description
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 Time Frame
Prior to ingestion of study medication to 2 hours after ingestion of the study medication
Outcome Measure
Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline
Outcome Description
Number of patients who received additional analgesics divided by total number of patients x 100
Outcome Time Frame
Entire two-hour time period
Outcome Measure
Percentage of Patients Who Received Rescue Medication
Outcome Description
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 Time Frame
End of two-hour time period
Outcome Measure
Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain
Outcome Description
Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100
Outcome Time Frame
From time of ingestion of study medication to one hour later
Outcome Measure
Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication
Outcome Description
Number of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100
Outcome Time Frame
From time of ingestion of study medication to two hours later
Outcome Measure
Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
64
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Polly Bijur
Investigator Email
polly.bijur@einsteinmed.org
Investigator Phone
718-430-4217