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Completed

NCT Number: NCT04122443

Acetaminophen (APAP) +/- Oxycodone

This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen

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Key information

Conditions

Musculoskeletal Pain Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
  • Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

Exclusion criteria

  • Use of an non-steroidal anti-inflammatory drug within the previous six hours
  • Use of acetaminophen within the previous six hours
  • Use of an opioid within the previous ten days
  • Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain
  • Gout

Treatment and study plan

Acetaminophen

Drug

Acetaminophen 650mg

Oxycodone

Drug

Oxycodone 10mg

Primary outcomes

  1. Change in Pain Assessment

    Time frame: 2 hours following treatment

    Stage 1 (Open label): No Outcome Measures assessed

    Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.

Secondary outcomes

  1. Sustained Pain Relief

    Time frame: Up to 48 hours following medication administration

    Stage 1 (Open label): No Outcome Measures assessed

    Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category.

  2. Adequacy of Analgesia

    Time frame: 2 hours following treatment

    Stage 1 (Open label): No Outcome Measures assessed

    Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category.

  3. Satisfaction With Medication

    Time frame: 2 hours following treatment

    Stage 1 (Open label): No Outcome Measures assessed

    Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure"

  4. Medication-related Adverse Events

    Time frame: 2 hours following treatment

    Stage 1 (Open label): No Outcome Measures assessed

    Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2019
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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