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Comparative Efficacy of 4 Oral Analgesics

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ClinicalTrials.gov Identifier: NCT02455518
Recruitment Status : Completed
First Posted : May 28, 2015
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, MD, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE May 22, 2015
First Posted Date  ICMJE May 28, 2015
Results First Submitted Date  ICMJE December 14, 2017
Results First Posted Date  ICMJE February 13, 2018
Last Update Posted Date February 13, 2018
Study Start Date  ICMJE July 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Between group difference in change in NRS pain scores [ Time Frame: 2 hours ]
Change in NRS pre and 2 hours post receiving study medication while in the ED
Change History Complete list of historical versions of study NCT02455518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
  • Between group difference in side effects [ Time Frame: 1 and 2 hours ]
    Proportion with side effects (nausea, vomiting, pruritus, dizziness, drowsiness)
  • Satisfaction assessed by 4-point Likert scale: very satisfied, satisfied, unsatisfied, or very unsatisfied with the study medication [ Time Frame: 2 hour ]
  • Between group difference in Likert pain scores [ Time Frame: 1 and 2 hours ]
    Pain evaluation on a 4-point Likert scale (none, mild, moderate, severe),
  • Between group difference in change in NRS pain scores [ Time Frame: 1 hour ]
    Change in NRS pre and 1 hour post receiving study medication while in the ED
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Efficacy of 4 Oral Analgesics
Official Title  ICMJE Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain
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.
Detailed Description

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:

  1. Oxycodone/acetaminophen (5/325)
  2. Hydrocodone/acetaminophen (5/325)
  3. Codeine/acetaminophen (30/300)
  4. Ibuprofen/acetaminophen (400/1000)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Oxycodone/acetaminophen
    Other Name: Percocet
  • Drug: Hydrocodone/acetaminophen
    Other Name: Norco
  • Drug: Codeine/acetaminophen
    Other Name: Tylenol with codeine
  • Drug: Ibuprofen/acetaminophen
Study Arms  ICMJE
  • Active Comparator: Oxycodone/acetaminophen
    Oxycodone/acetaminophen (5 mg/325 mg)
    Intervention: Drug: Oxycodone/acetaminophen
  • Active Comparator: Hydrocodone/acetaminophen
    Hydrocodone/acetaminophen (5 mg/300 mg)
    Intervention: Drug: Hydrocodone/acetaminophen
  • Active Comparator: Codeine/acetaminophen
    Codeine/acetaminophen (30 mg/300 mg)
    Intervention: Drug: Codeine/acetaminophen
  • Active Comparator: Ibuprofen/acetaminophen
    Ibuprofen/acetaminophen (400 mg/1000 mg)
    Intervention: Drug: Ibuprofen/acetaminophen
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2018)
416
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2015)
400
Actual Study Completion Date  ICMJE October 4, 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02455518
Other Study ID Numbers  ICMJE 2014-4156
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Chang, MD, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Montefiore Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP