Clinical trial NCT03173456: Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)
Official title: Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Musculoskeletal Pain
Keywords: acute pain
musculoskeletal pain
emergency medicine
Emergency Service, Hospital
analgesics
Acetaminophen
Ibuprofen
oxycodone
hydrocodone
codeine
adult
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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).

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.

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

Primary outcomes:
measure: Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline
timeFrame: Prior to Ingestion of study medication to one hour after ingestion of the study medication
Secondary outcomes:
measure: Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline
timeFrame: Prior to ingestion of study medication to 2 hours after ingestion of the study medication
measure: Percentage of Patients Who Received Rescue Medication
timeFrame: Entire two-hour time period
measure: Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain
timeFrame: End of two-hour time period
measure: Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication
timeFrame: From time of ingestion of study medication to one hour later
measure: Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication
timeFrame: From time of ingestion of study medication to two hours later
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Benjamin Friedman, MD
role: STUDY_DIRECTOR
References:
citation: Bijur PE, Friedman BW, Irizarry E, Chang AK, Gallagher EJ. A Randomized Trial Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department. Ann Emerg Med. 2021 Mar;77(3):345-356. doi: 10.1016/j.annemergmed.2020.10.004. Epub 2020 Dec 23.