Comparative Efficacy of 4 Oral Analgesics

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Oxycodone/acetaminophen; Drug: Hydrocodone/acetaminophen; Drug: Codeine/acetaminophen; Drug: Ibuprofen/acetaminophen

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: Interventional
• Enrollment (Actual): 416
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxycodone/acetaminophen; Oxycodone/acetaminophen (5 mg/325 mg)	Drug: Oxycodone/acetaminophen; Other Names: Percocet
Active Comparator: Hydrocodone/acetaminophen; Hydrocodone/acetaminophen (5 mg/300 mg)	Drug: Hydrocodone/acetaminophen; Other Names: Norco
Active Comparator: Codeine/acetaminophen; Codeine/acetaminophen (30 mg/300 mg)	Drug: Codeine/acetaminophen; Other Names: Tylenol with codeine
Active Comparator: Ibuprofen/acetaminophen; Ibuprofen/acetaminophen (400 mg/1000 mg)	Drug: Ibuprofen/acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores	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)	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores	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)	1 hour

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 4, 2017

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Acetaminophen; Ibuprofen; Oxycodone; Codeine; Hydrocodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: 2014-4156