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Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge

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ClinicalTrials.gov Identifier: NCT01402375
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, MD, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE July 24, 2011
First Posted Date  ICMJE July 26, 2011
Results First Submitted Date  ICMJE March 1, 2018
Results First Posted Date  ICMJE May 1, 2018
Last Update Posted Date May 1, 2018
Actual Study Start Date  ICMJE January 2012
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
Difference in Pain Intensity Score Before and After Last Dose. [ Time Frame: 2 hrs ]
Pain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken.
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
Difference in pain score before and after last dose [ Time Frame: 24 hrs ]
The difference between average pain scores on an 11-point numeric rating scale (NRS) between the time immediately before the most recent dose of pain medication and two hours after.
Change History Complete list of historical versions of study NCT01402375 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
Overall Satisfaction With the Pain Medicine [ Time Frame: 24 hrs ]
Overall satisfaction with the oral opioid pain medication at 24 hours after discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied or very unsatisfied with the study medication.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • Overall satisfaction with the pain medicine [ Time Frame: 24 hrs ]
    Overall satisfaction with the oral opioid pain medication at 24 hours after ED discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied, or very unsatisfied with the study medication.
  • Side Effects [ Time Frame: 24 hrs ]
    Types and numbers of side effects experienced and average pain scores over the 24 hours after ED discharge.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge
Official Title  ICMJE Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge
Brief Summary There will be 3 randomized, double-blinded clinical trials to help determine which of commonly prescribed oral opioid combination is most effective in managing acute extremity pain after discharge from the adult emergency department. The first trial compares hydrocodone 5mg / acetaminophen 500mg to codeine 30mg/acetaminophen 300mg. The second trial compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg. The third trial compares oxycodone 5mg/acetaminophen 325 mg to hydrocodone 5mg/acetaminophen 325 mg.
Detailed Description

Eligible patients are those between the ages of 21 and 64 who present to the Emergency Department (ED) with a complaint of acute extremity pain of less than seven days duration in one or more extremities and for whom the clinician plans to discharge on an oral opioid for pain management. Patients will be excluded if they have ever taken methadone; have a chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy; report a history of an adverse reaction to any of the study medications; if they have taken prescribed opioids in the past 24 hours or if they report having ever taken recreational narcotics; if they have a medical condition that might affect their metabolism of opioid analgesics or acetaminophen; or if they take any medicine that might interact with one of the study medications. Patients will be referred by the attending physician or clinician and consent as well as the initial and follow-up data collections will be obtained by our team of trained bilingual (Spanish and English) salaried research associates who staff the ED 24 hours a day and 7 days a week.

In the first study, patients will be randomized to one of two experimental groups: hydrocodone 5mg / acetaminophen 500mg or codeine 30mg / acetaminophen 300mg. Randomization will be performed in blocks of 10 and determined by a sequence generated at http://www.randomization.com. The pharmacist working in an area inaccessible to ED staff will ensure proper blinding of the study by masking the medication and inserting it into unmarked gel capsules and filling any void with small amounts of lactose. A three-day supply (18 doses) of the blinded medications will be dispensed by the ED staff to the patient in the order determined by randomization accompanied by instructions to use one tablet of the medication every 4 hours as needed for pain and to avoid use of any other analgesics.

Using a power of 80%, a significance criterion of 0.5, and an estimated delta of 1.3 NRS units, a sample size of 85 patients per group. In order to account for those that do not end up taking the medicine, it is estimated that 120 patients per group will have to be enrolled.

Data will be collected on a standardized data collection instrument, entered by a trained data clerk, and reviewed and audited for accuracy and completeness. The investigators will calculate descriptive statistics for all variables: frequencies, means and standard deviations, medians and IQR, and proportions. Chi-square tests will be used to test differences between dichotomous variables, t-tests will be used to test mean differences. Multivariate models will be used if there are background variables that are unevenly distributed between the two groups. Variables associated with group membership with probability of 0.20 or less will be included in OLS multivariate regression or logistic regression models in order to test the role of group membership while accounting for chance baseline disparities. Interaction terms will be tested and dropped from the models if they were not statically significant at the 0.05 level. SPSS version 17 (Chicago, IL.) will be used to conduct all data analyses.

The second trial will be identical to the first trial with the exception of one of the study drugs, which will be oxycodone 5mg / acetaminophen 325 mg which will be compared to codeine 30mg / acetaminophen 300mg.

The third trial will be identical to the first and second trials with the exception of study drugs. This study will use oxycodone 5 mg/acetaminophen 325mg and hydrocodone 5mg/acetaminophen 325mg.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Analgesia After ED Discharge for Extremity Injuries
Intervention  ICMJE
  • Drug: Hydrocodone (first trial)
    Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain
    Other Name: Vicodin (Hydrocodone 5mg / Acetaminophen 500mg)
  • Drug: Codeine (first trial)
    Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
    Other Name: Tylenol # 3 (Codeine 30 mg/Acetaminophen 300 mg)
  • Drug: Oxycodone (for second trial)
    Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain
    Other Name: Percocet (Oxycodone 5mg/Acetaminophen 325 mg)
  • Drug: Codeine (for second trial)
    Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
    Other Name: Tylenol # 3 (Codeine 30 mg/Acetaminophen 300 mg)
  • Drug: Oxycodone (third trial)
    Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain
    Other Name: Oxycodone 5mg / Acetaminophen 325 mg
  • Drug: Hydrocodone (third trial)
    Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
    Other Name: Hydrocodone 5mg / Acetaminophen 325 mg
Study Arms  ICMJE
  • Experimental: Hydrocodone (first trial)
    Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
    Intervention: Drug: Hydrocodone (first trial)
  • Active Comparator: Codeine (first trial)
    Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
    Intervention: Drug: Codeine (first trial)
  • Experimental: Oxycodone (for second trial)
    Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
    Intervention: Drug: Oxycodone (for second trial)
  • Active Comparator: Codeine (for second trial)
    Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
    Intervention: Drug: Codeine (for second trial)
  • Experimental: Oxycodone (third trial)
    Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
    Intervention: Drug: Oxycodone (third trial)
  • Active Comparator: Hydrocodone (third trial)
    Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
    Intervention: Drug: Hydrocodone (third trial)
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: April 27, 2018)
720
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2011)
240
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patient has complaint of acute extremity pain (less than 7 days duration)
  • clinician plans to discharge on oral pain medication

Exclusion Criteria:

  • patients on methadone
  • chronic pain condition such as sickle cell anemia or fibromyalgia
  • history of adverse reaction to one of the study medications
  • taken prescribed opioids in the past 24 hrs
  • have a medical condition that might alter the metabolism of one of the study medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)
  • Take a medication that might interact with one of the study medications
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 NCT01402375
Other Study ID Numbers  ICMJE 11-02-066
Has Data Monitoring Committee No
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
Principal Investigator: Andrew Chang, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date April 2018

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