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

Primary Purpose

Musculoskeletal Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

oxycodone/APAP

hydrocodone/APAP

codeine/APAP

400 ibuprofen/APAP

800 ibuprofen/APAP

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring acute pain, musculoskeletal pain, emergency medicine, Emergency Service, Hospital, analgesics, Acetaminophen, Ibuprofen, oxycodone, hydrocodone, codeine, adult

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Arm Label

oxycodone/acetaminophen (APAP)

hydrocodone/APAP

codeine/APAP

400 ibuprofen/APAP

800 ibuprofen/APAP

Arm Description

5 mg oxycodone + 325 mg acetaminophen

5 mg hydrocodone + 300 mg acetaminophen

30 mg codeine + 300 mg acetaminophen

400 mg ibuprofen + 1000 mg acetaminophen

800 mg ibuprofen + 1000 mg acetaminophen

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Percentage of Patients Who Received Rescue Medication

Number of patients who received additional analgesics 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

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

Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100

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

Full Information

NCT ID

NCT03173456

First Posted

May 30, 2017

Last Updated

January 2, 2022

Sponsor

Albert Einstein College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03173456

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

November 28, 2017 (Actual)

Primary Completion Date

November 14, 2019 (Actual)

Study Completion Date

November 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Albert Einstein College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Musculoskeletal Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oxycodone/acetaminophen (APAP)

Arm Type

Active Comparator

Arm Description

5 mg oxycodone + 325 mg acetaminophen

Arm Title

hydrocodone/APAP

Arm Type

Active Comparator

Arm Description

5 mg hydrocodone + 300 mg acetaminophen

Arm Title

codeine/APAP

Arm Type

Active Comparator

Arm Description

30 mg codeine + 300 mg acetaminophen

Arm Title

400 ibuprofen/APAP

Arm Type

Active Comparator

Arm Description

400 mg ibuprofen + 1000 mg acetaminophen

Arm Title

800 ibuprofen/APAP

Arm Type

Active Comparator

Arm Description

800 mg ibuprofen + 1000 mg acetaminophen

Intervention Type

Drug

Intervention Name(s)

oxycodone/APAP

Other Intervention Name(s)

Percocet

Intervention Description

Oxycodone/acetaminophen 5 mg-325 mg oral tablet

Intervention Type

Drug

Intervention Name(s)

hydrocodone/APAP

Other Intervention Name(s)

Vicodin

Intervention Description

Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet

Intervention Type

Drug

Intervention Name(s)

codeine/APAP

Other Intervention Name(s)

Tylenol # 3

Intervention Description

Codeine/acetaminophen 30 mg-300mg oral tablet

Intervention Type

Drug

Intervention Name(s)

400 ibuprofen/APAP

Other Intervention Name(s)

Motrin, Tylenol

Intervention Description

ibuprofen/acetaminophen 400 mg-1000mg oral tablet

Intervention Type

Drug

Intervention Name(s)

800 ibuprofen/APAP

Other Intervention Name(s)

Motrin, Tylenol

Intervention Description

ibuprofen/acetaminophen 800 mg-1000 mg oral tablet

Primary Outcome Measure Information:

Title

Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline

Description

Time Frame

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

Title

Percentage of Patients Who Received Rescue Medication

Description

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

Time Frame

Entire two-hour time period

Title

Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain

Description

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

Time Frame

End of two-hour time period

Title

Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication

Description

Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100

Time Frame

From time of ingestion of study medication to one hour later

Title

Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication

Description

Number of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100

Time Frame

From time of ingestion of study medication to two hours later

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Friedman, MD

Organizational Affiliation

Albert Einstein College of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33358232

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.

Results Reference

derived

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

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