NCT02455518

Brief Summary

The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Jul 2015

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2017

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 13, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

May 22, 2015

Results QC Date

December 14, 2017

Last Update Submit

February 7, 2018

Conditions

Pain

Keywords

pain

Outcome Measures

Primary Outcomes (1)

  • Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores

    Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)

    2 hours

Secondary Outcomes (1)

  • Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores

    1 hour

Study Arms (4)

Oxycodone/acetaminophen

ACTIVE COMPARATOR

Oxycodone/acetaminophen (5 mg/325 mg)

Drug: Oxycodone/acetaminophen

Hydrocodone/acetaminophen

ACTIVE COMPARATOR

Hydrocodone/acetaminophen (5 mg/300 mg)

Drug: Hydrocodone/acetaminophen

Codeine/acetaminophen

ACTIVE COMPARATOR

Codeine/acetaminophen (30 mg/300 mg)

Drug: Codeine/acetaminophen

Ibuprofen/acetaminophen

ACTIVE COMPARATOR

Ibuprofen/acetaminophen (400 mg/1000 mg)

Drug: Ibuprofen/acetaminophen

Interventions

Oxycodone/acetaminophenDRUG
Also known as: Percocet
Oxycodone/acetaminophen
Hydrocodone/acetaminophenDRUG
Also known as: Norco
Hydrocodone/acetaminophen
Codeine/acetaminophenDRUG
Also known as: Tylenol with codeine
Codeine/acetaminophen
Ibuprofen/acetaminophenDRUG
Ibuprofen/acetaminophen

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complaint of acute pain of \< 7 days duration
  • Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
  • Radiologic evaluation is planned

You may not qualify if:

  • Inability to confirm reliable means of phone followup.
  • Past use of methadone
  • Chronic condition requiring frequent pain management such as 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 8 hours
  • Pregnancy by either urine or serum HCG testing
  • Breastfeeding per patient report
  • History of peptic ulcer disease
  • Report of any prior use of recreational narcotics
  • 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
  • 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, ritanovir, terbinafine, or St John's Wort.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.

    PMID: 29114833DERIVED

MeSH Terms

Conditions

Pain

Interventions

oxycodone-acetaminophenacetaminophen, codeine drug combinationIbuprofenAcetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Results Point of Contact

Title
Dr. Andrew Chang
Organization
Albany Medical College
achang3@yahoo.com
2125555555

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 22, 2015

First Posted

May 28, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2016

Study Completion

October 4, 2017

Last Updated

February 13, 2018

Results First Posted

February 13, 2018

Record last verified: 2018-02

Locations

US(1)