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

NCT03173456 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2016-7322
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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).

Conditions

Musculoskeletal Pain

Keywords

acute pain; musculoskeletal pain; emergency medicine; Emergency Service, Hospital; analgesics; Acetaminophen; Ibuprofen; oxycodone; hydrocodone; codeine; adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Percentage of Patients Who Received Rescue Medication

  Entire two-hour time period

• 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

• 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

• 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

Study Arms (5)

oxycodone/acetaminophen (APAP)

ACTIVE COMPARATOR

5 mg oxycodone + 325 mg acetaminophen

Drug: oxycodone/APAP

hydrocodone/APAP

ACTIVE COMPARATOR

5 mg hydrocodone + 300 mg acetaminophen

Drug: hydrocodone/APAP

codeine/APAP

ACTIVE COMPARATOR

30 mg codeine + 300 mg acetaminophen

Drug: codeine/APAP

400 ibuprofen/APAP

ACTIVE COMPARATOR

400 mg ibuprofen + 1000 mg acetaminophen

Drug: 400 ibuprofen/APAP

800 ibuprofen/APAP

ACTIVE COMPARATOR

800 mg ibuprofen + 1000 mg acetaminophen

Drug: 800 ibuprofen/APAP

Interventions

oxycodone/APAP DRUG

Oxycodone/acetaminophen 5 mg-325 mg oral tablet

Also known as: Percocet

oxycodone/acetaminophen (APAP)

hydrocodone/APAP DRUG

Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet

Also known as: Vicodin

hydrocodone/APAP

codeine/APAP DRUG

Codeine/acetaminophen 30 mg-300mg oral tablet

Also known as: Tylenol # 3

codeine/APAP

400 ibuprofen/APAP DRUG

ibuprofen/acetaminophen 400 mg-1000mg oral tablet

Also known as: Motrin, Tylenol

400 ibuprofen/APAP

800 ibuprofen/APAP DRUG

ibuprofen/acetaminophen 800 mg-1000 mg oral tablet

Also known as: Motrin, Tylenol

800 ibuprofen/APAP

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 33358232 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain; Acute Pain; Emergencies

Interventions

oxycodone-acetaminophen; acetaminophen, hydrocodone drug combination; Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Dr. Polly Bijur
• Organization: Department of Emergency Medicine Albert Einstein Coll of Med

polly.bijur@einsteinmed.org

914-661-4707

Study Officials

• Benjamin Friedman, MD

  Albert Einstein College of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A pharmacist working in an area inaccessible to ED staff will ensure blinding of the study by masking the medication and inserting it into identical unmarked gel capsules, filling any void with small amounts of lactose. Randomization will be performed in blocks of 10 determined by a sequence generated at http://www.randomization.com. The pharmacist will make up numbered research packets based on the random allocation list, each with 5 tablets containing the masked investigational medication. Research packets will be removed sequentially by the nurse from the Pyxis automated medical dispensing system and administered to the study patients in the ED.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: November 28, 2017
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: February 1, 2022
• Results First Posted: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)