Opioid medication as part of standard care for Acute Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Miriam Hospital, Providence, RI
Acute Pain
Opioid medication as part of standard care - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether an honest placebo can reduce opioid use and pain for people with acute pain.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Acute Pain

Study Objectives

This trial is evaluating whether Opioid medication as part of standard care will improve 1 primary outcome and 2 secondary outcomes in patients with Acute Pain. Measurement will happen over the course of 7 days.

7 days
Pain Intensity
Pain Interference
Prescription Opioid Use

Trial Safety

Safety Progress

1 of 3

Other trials for Acute Pain

Trial Design

1 Treatment Group

Open Label Placebo + Treatment as Usual
1 of 1
Experimental Treatment

This trial requires 155 total participants across 1 different treatment group

This trial involves a single treatment. Opioid Medication As Part Of Standard Care is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Open Label Placebo + Treatment as UsualOpioid medication, as prescribed in routine care + Honest placebos
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Open Placebo
2018
Completed Early Phase 1
~10

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 days for reporting.

Closest Location

The Miriam Hospital - Providence, RI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Inclusion
18 years or older
English Speaking
Has a working smart-phone
Able to provide informed consent
Present for upper or lower extremity fracture (ED sample only) or for hand or wrist surgery (hand surgery sample only)
Are expected to be prescribed opioids at discharge
Are expected to be discharged from the Emergency Department (ED sample only)
Intends to take 1 or more doses of opioid medication as prescribed
Exclusion

Patient Q&A Section

What is acute pain?

"The subjective perception of pain may arise from multiple sources including the peripheral nervous system (PNS), the central nervous system (CNS), the brain, and the spinal cord. Each of these sources can have distinct physiological mechanisms of pain perception, which can in turn be modulated by a variety of factors such as environment, disease states, and the state of consciousness. The most common clinical presentation of acute pain is sudden, severe, and episodic in character." - Anonymous Online Contributor

Unverified Answer

Can acute pain be cured?

"There is no evidence that acute pain can be cured. There are a variety of nonmedical treatments options for acute pain, but many of them appear ineffective in resolving some acute pain conditions. Chronic nonmedical pain, such as chronic back pain, can be cured by a variety of nonmedical and medical treatments. In some cases, a short period of pain medication is curative to reduce pain intensity and reduce the likelihood of developing a chronic pain condition, such as chronic headache." - Anonymous Online Contributor

Unverified Answer

What are common treatments for acute pain?

"More than 1 in 9 Americans report having been prescribed some type of analgesic, many of which were prescription opioids. Most of these people reported pain lasting more than seven days, and most of them reported prescription opioids." - Anonymous Online Contributor

Unverified Answer

How many people get acute pain a year in the United States?

"Approximately 38.4 million Americans a year experience acute pain. It is one of the most frequently reported health problems in society and accounts for a large portion of emergency room visits and a high percentage of hospital days of care." - Anonymous Online Contributor

Unverified Answer

What are the signs of acute pain?

"Many patients with acute pain have no symptoms or their pain is so mild that they are not taken seriously. Analgesic drugs are used but rarely are sufficient. In some patients there is no effective analgesia and the pain persists. Some pain is so severe that the patient cannot take their pain seriously and does not seek medical help urgently." - Anonymous Online Contributor

Unverified Answer

What causes acute pain?

"The most common causes of pain were infection, trauma, or disease, which was most often due to arthritis, a disease of the synovial joint. In the second and third decades of life, chronic pain was most common in females and pain in extremities such as arthritis and osteoarthritis. Chronic pain most commonly originated from the lower back. The most common cause of chronic pain and extremity pain was arthritis. For other types of pain, chronic pain was found to be most often due to heart failure, which resulted in cardiovascular diseases." - Anonymous Online Contributor

Unverified Answer

How serious can acute pain be?

"Because symptoms and signs of pain were more common in patients with more critical lesions, the decision to treat with analgesics is a difficult one to make. Therefore, we recommend initial evaluations for each individual patient, including the determination of the seriousness of pain, the patient's baseline pain, the extent of the pathology and the patient's expectations for outcomes." - Anonymous Online Contributor

Unverified Answer

What does opioid medication as part of standard care usually treat?

"Pain management with opioid medications as part of standard care for patients with abdominal pain at the end of life is common. Physicians should be mindful of the use of morphine, oxycodone, and fentanyl in patients with acute and chronic pain, in particular for patients with pain in the end stages of life. It is time to stop using these medications in this setting when they are not medically necessary." - Anonymous Online Contributor

Unverified Answer

Has opioid medication as part of standard care proven to be more effective than a placebo?

"Opioid medication as part of standard care with an opioid switch to oral medication for postoperative pain was not more effective than a placebo for reducing the use of opioids and morphine during hospital stays after hip and knee arthroplasty. This lack of statistical significance may be attributable to the very low magnitude of change, especially with respect to the use of postoperative opioids. Findings from a recent study should be interpreted cautiously given the uncertainty of the clinical relevance of the magnitude of any change." - Anonymous Online Contributor

Unverified Answer

Is opioid medication as part of standard care safe for people?

"This large post-hoc analysis suggests that opioid medication is safe as a part of standard analgesic management of acute pain due to fracture, as long as patient is adequately managed for other potential acute complications." - Anonymous Online Contributor

Unverified Answer

Is opioid medication as part of standard care typically used in combination with any other treatments?

"A large minority of opioid recipients use combined therapy by default; this practice may be associated with an increased risk of adverse outcome and an increased number of adverse events as it requires more frequent outpatient visits and a more complicated management plan." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for acute pain?

"In patients with acute pain, patients will usually seek care from their primary care physician. Because chronic pain is an uncommon presenting symptom, it is important to have an acute care hospital-based referral for evaluation of acute pain." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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