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Musculoskeletal PainPhase 2NCT03173456

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

A Phase 2 study testing oxycodone/APAP, hydrocodone/APAP and codeine/APAP in people with Musculoskeletal Pain, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 21 to 64 years
Conditions the study is for
Musculoskeletal Pain
What is being tested?
oxycodone/APAP, hydrocodone/APAP and codeine/APAP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
28 Nov 2017to 14 Nov 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
oxycodone/APAP, hydrocodone/APAP, codeine/APAP, 400 ibuprofen/APAP, 800 ibuprofen/APAP
Keywords
acute pain, musculoskeletal pain, emergency medicine, Emergency Service, Hospital, analgesics, Acetaminophen, Ibuprofen, oxycodone, hydrocodone, codeine, adult
Medical subject headings
Musculoskeletal Pain, Acute Pain, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oxycodone/APAPDrug

    Also called Percocet

    Oxycodone/acetaminophen 5 mg-325 mg oral tablet

  • hydrocodone/APAPDrug

    Also called Vicodin

    Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet

  • codeine/APAPDrug

    Also called Tylenol # 3

    Codeine/acetaminophen 30 mg-300mg oral tablet

  • 400 ibuprofen/APAPDrug

    Also called Motrin, Tylenol

    ibuprofen/acetaminophen 400 mg-1000mg oral tablet

  • 800 ibuprofen/APAPDrug

    Also called Motrin, Tylenol

    ibuprofen/acetaminophen 800 mg-1000 mg oral tablet

Study groups in NCT03173456
Study groupRoleWhat they receive
oxycodone/acetaminophen (APAP)Active comparator5 mg oxycodone + 325 mg acetaminophen
Receives: Drug: oxycodone/APAP
hydrocodone/APAPActive comparator5 mg hydrocodone + 300 mg acetaminophen
Receives: Drug: hydrocodone/APAP
codeine/APAPActive comparator30 mg codeine + 300 mg acetaminophen
Receives: Drug: codeine/APAP
400 ibuprofen/APAPActive comparator400 mg ibuprofen + 1000 mg acetaminophen
Receives: Drug: 400 ibuprofen/APAP
800 ibuprofen/APAPActive comparator800 mg ibuprofen + 1000 mg acetaminophen
Receives: Drug: 800 ibuprofen/APAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Prior to Ingestion of study medication to one hour after ingestion of the study medication

Secondary outcomes (5)

  1. 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.

    Measured: Prior to ingestion of study medication to 2 hours after ingestion of the study medication

  2. Percentage of Patients Who Received Rescue Medication

    Number of patients who received additional analgesics divided by total number of patients x 100

    Measured: Entire two-hour time period

  3. 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

    Measured: End of two-hour time period

  4. 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

    Measured: From time of ingestion of study medication to one hour later

  5. 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

    Measured: From time of ingestion of study medication to two hours later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2017
  2. Study start28 Nov 2017
  3. Primary completion14 Nov 2019
  4. Study completion14 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03173456
Sponsor's protocol ID
2016-7322
Status last verified
Jan 2022
First submitted
30 May 2017
Last updated
1 Feb 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33358232

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxycodone/APAP, hydrocodone/APAP and codeine/APAP in people with Musculoskeletal Pain, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline (time frame: Prior to Ingestion of study medication to one hour after ingestion of the study medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03173456, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.

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