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

Phase 2

Completed

Conditions: Musculoskeletal Pain

Interventions: Drug: codeine/APAP
Drug: oxycodone/APAP
Drug: 800 ibuprofen/APAP
Drug: hydrocodone/APAP
Drug: 400 ibuprofen/APAP

Registration Number: NCT03173456

Lead Sponsor: Albert Einstein College of Medicine

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 600

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
codeine/APAP	codeine/APAP	30 mg codeine + 300 mg acetaminophen
oxycodone/acetaminophen (APAP)	oxycodone/APAP	5 mg oxycodone + 325 mg acetaminophen
800 ibuprofen/APAP	800 ibuprofen/APAP	800 mg ibuprofen + 1000 mg acetaminophen
hydrocodone/APAP	hydrocodone/APAP	5 mg hydrocodone + 300 mg acetaminophen
400 ibuprofen/APAP	400 ibuprofen/APAP	400 mg ibuprofen + 1000 mg acetaminophen

Primary Outcome Measures

Name	Time	Method
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline	Prior to Ingestion of study medication to one hour after ingestion of the study medication	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.

Secondary Outcome Measures

Name	Time	Method
Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline	Prior to ingestion of study medication to 2 hours after ingestion of the study medication	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.
Percentage of Patients Who Received Rescue Medication	Entire two-hour time period	Number of patients who received additional analgesics divided by total number of patients x 100
Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication	From time of ingestion of study medication to two hours later	Number of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100
Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain	End of two-hour time period	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
Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication	From time of ingestion of study medication to one hour later	Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100