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

Musculoskeletal Pain Clinical Trial

Official title:

Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173456
• Other study ID #: 2016-7322
• Status: Completed
• Phase: Phase 2
• Start date: November 28, 2017
• Est. completion date: November 14, 2019

Study information

• Verified date: January 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: November 14, 2019
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Musculoskeletal Pain

Intervention

Drug:
• oxycodone/APAP
Oxycodone/acetaminophen 5 mg-325 mg oral tablet
• hydrocodone/APAP
Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
• codeine/APAP
Codeine/acetaminophen 30 mg-300mg oral tablet
• 400 ibuprofen/APAP
ibuprofen/acetaminophen 400 mg-1000mg oral tablet
• 800 ibuprofen/APAP
ibuprofen/acetaminophen 800 mg-1000 mg oral tablet

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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