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Completed

NCT Number: NCT02455518

Comparative Efficacy of 4 Oral Analgesics

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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. The 4 groups are as follows:

  • Oxycodone/acetaminophen (5/325)
  • Hydrocodone/acetaminophen (5/325)
  • Codeine/acetaminophen (30/300)
  • Ibuprofen/acetaminophen (400/1000)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Oxycodone/acetaminophen

Drug

Other names: Percocet

Hydrocodone/Acetaminophen

Drug

Other names: Norco

Codeine/acetaminophen

Drug

Other names: Tylenol with codeine

Ibuprofen/acetaminophen

Drug

Primary outcomes

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

    Time frame: 2 hours

    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)

Secondary outcomes

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

    Time frame: 1 hour

    Change in numerical rating scale (NRS) pre and 1-hour 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)

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 28, 2015
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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