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Trial record 19 of 75 for:    Codeine AND Acetaminophen

Comparing Five Oral Analgesics for Treatment of Acute Pain in the ED

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ClinicalTrials.gov Identifier: NCT03173456
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Polly Bijur, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE May 30, 2017
First Posted Date  ICMJE June 1, 2017
Last Update Posted Date November 18, 2019
Actual Study Start Date  ICMJE November 28, 2017
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2017)
Change in patients' rating of pain intensity from time of ingestion of study medication to one hour after ingestion of the study medication. [ Time Frame: Ingestion of study medication to one hour after ingestion of the study medication ]
Pain intensity measured by 11-point Numerical Rating Scale of Pain
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03173456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2017)
  • Change in patients' rating of pain intensity from time of ingestion of study medication to two hours after ingestion of the study medication. [ Time Frame: Ingestion of study medication to two hours after ingestion of the study medication ]
    Pain intensity measured by 11-point Numerical Rating Scale of Pain
  • Proportion of patients who receive rescue medication [ Time Frame: Entire two-hour time period ]
    Record of additional analgesics
  • Proportion of patients who would choose to take the study medication again if they returned to the ED with similar pain [ Time Frame: End of two-hour time period ]
    Question asked at end of two-hour time period
  • Proportion of patients who experience side effects one hour after ingestion of study medication [ Time Frame: From time of ingestion of study medication to one hour later ]
    Question asked at one hour
  • Proportion of patients who experience side effects in two hours after ingestion of study medication [ Time Frame: From time of ingestion of study medication to two hours later ]
    Question asked at two hours
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Five Oral Analgesics for Treatment of Acute Pain in the ED
Official Title  ICMJE Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the ED
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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 indentical 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.
Primary Purpose: Treatment
Condition  ICMJE Musculoskeletal Pain
Intervention  ICMJE
  • Drug: oxycodone/APAP
    Oxycodone/acetaminophen 5 mg-325 mg oral tablet
    Other Name: Percocet
  • Drug: hydrocodone/APAP
    Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
    Other Name: Vicodin
  • Drug: codeine/APAP
    Codeine/acetaminophen 30 mg-300mg oral tablet
    Other Name: Tylenol # 3
  • Drug: 400 ibuprofen/APAP
    ibuprofen/acetaminophen 400 mg-1000mg oral tablet
    Other Name: Motrin, Tylenol
  • Drug: 800 ibuprofen/APAP
    ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
    Other Name: Motrin, Tylenol
Study Arms  ICMJE
  • Active Comparator: oxycodone/APAP
    5 mg oxycodone + 325 mg acetaminophen
    Intervention: Drug: oxycodone/APAP
  • Active Comparator: hydrocodone/APAP
    5 mg hydrocodone + 300 mg acetaminophen
    Intervention: Drug: hydrocodone/APAP
  • Active Comparator: codeine/APAP
    30 mg codeine + 300 mg acetaminophen
    Intervention: Drug: codeine/APAP
  • Active Comparator: 400 ibuprofen/APAP
    400 mg ibuprofen + 1000 mg acetaminophen
    Intervention: Drug: 400 ibuprofen/APAP
  • Active Comparator: 800 ibuprofen/APAP
    800 mg ibuprofen + 1000 mg acetaminophen
    Intervention: Drug: 800 ibuprofen/APAP
Publications * Not Provided

*   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: November 14, 2019)
600
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2017)
550
Actual Study Completion Date  ICMJE November 14, 2019
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 HCG 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, ritanovir, terbinafine, or St John's Wort
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 64 Years   (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 NCT03173456
Other Study ID Numbers  ICMJE 2016-7322
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Polly Bijur, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Polly Bijur, PhD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date November 2019

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