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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
Andrew Chang, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01402375
First received: July 24, 2011
Last updated: June 1, 2013
Last verified: June 2013
  Purpose

There will be 2 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 while the second trial compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg.


Condition Intervention Phase
Analgesia After ED Discharge for Extremity Injuries
Drug: Oral Opioid Pain Medicine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Difference in pain score before and after last dose. [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Satisfaction with the pain medicine [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    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.

  • Side Effects [ Time Frame: 24 hrs ] [ Designated as safety issue: Yes ]
    Types and numbers of side effects experienced and average pain scores over the 24 hours after ED discharge.


Estimated Enrollment: 480
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrocodone
Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Drug: Oral Opioid Pain Medicine

In the first trial, patients will take 1 dose of either Hydrocodone or Codeine combined with Acetaminophen every 4 hours as needed for pain.

In the second trial, patients will take 1 dose of either oxycodone or Codeine combined with Acetaminophen every 4 hours as needed for pain.

Other Names:
  • Vicodin (Hydrocodone 5mg / Acetaminophen 500mg)
  • Tylenol # 3 (Codeine 30mg / Acetaminophen 300mg)
  • Percocet (Oxycodone 5mg/Acetaminophen 325 mg)
Active Comparator: Codeine
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Drug: Oral Opioid Pain Medicine

In the first trial, patients will take 1 dose of either Hydrocodone or Codeine combined with Acetaminophen every 4 hours as needed for pain.

In the second trial, patients will take 1 dose of either oxycodone or Codeine combined with Acetaminophen every 4 hours as needed for pain.

Other Names:
  • Vicodin (Hydrocodone 5mg / Acetaminophen 500mg)
  • Tylenol # 3 (Codeine 30mg / Acetaminophen 300mg)
  • Percocet (Oxycodone 5mg/Acetaminophen 325 mg)
Experimental: Oxycodone
Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Drug: Oral Opioid Pain Medicine

In the first trial, patients will take 1 dose of either Hydrocodone or Codeine combined with Acetaminophen every 4 hours as needed for pain.

In the second trial, patients will take 1 dose of either oxycodone or Codeine combined with Acetaminophen every 4 hours as needed for pain.

Other Names:
  • Vicodin (Hydrocodone 5mg / Acetaminophen 500mg)
  • Tylenol # 3 (Codeine 30mg / Acetaminophen 300mg)
  • Percocet (Oxycodone 5mg/Acetaminophen 325 mg)
Active Comparator: Codeine (for second trial)
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Drug: Oral Opioid Pain Medicine

In the first trial, patients will take 1 dose of either Hydrocodone or Codeine combined with Acetaminophen every 4 hours as needed for pain.

In the second trial, patients will take 1 dose of either oxycodone or Codeine combined with Acetaminophen every 4 hours as needed for pain.

Other Names:
  • Vicodin (Hydrocodone 5mg / Acetaminophen 500mg)
  • Tylenol # 3 (Codeine 30mg / Acetaminophen 300mg)
  • Percocet (Oxycodone 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.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402375

Contacts
Contact: Andrew Chang, MD achang3@yaho.com

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Andrew Chang, MD       achang3@yahoo.com   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Andrew Chang, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Andrew Chang, PI, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01402375     History of Changes
Other Study ID Numbers: 11-02-066
Study First Received: July 24, 2011
Last Updated: June 1, 2013
Health Authority: United States: Institutional Review Board
United States: Department of Health and Human Services
United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
Pain Management
Emergency Medicine
Extremity Injuries

Additional relevant MeSH terms:
Wounds and Injuries
Acetaminophen
Analgesics
Codeine
Hydrocodone
Oxycodone
Analgesics, Opioid
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on July 23, 2014