48 Participants NeededMy employer runs this trial

Buprenorphine for Pain from Broken Bones

KE
Overseen ByKatherine E Selman, MD
Age: 65+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: The Cooper Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether buprenorphine, an opioid medication, can effectively manage pain from broken bones in older adults with fewer side effects than opioids like hydromorphone. Participants with a broken bone will receive either buprenorphine or hydromorphone and will be monitored for pain relief and side effects. Ideal candidates are those aged 65 or older who have been admitted to the emergency department with a confirmed or suspected bone fracture and are experiencing significant pain. As a Phase 1, Phase 2 trial, this research aims to understand how buprenorphine works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been taking opioids regularly in the past month.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that buprenorphine is generally safe for treating sudden pain in older adults. One study found it effectively manages pain after bone fractures and maintains a good safety record. Patients mostly reported mild side effects, such as minor skin irritations from patches, which are not serious.

Hydromorphone, another option, has extensive use as an FDA-approved opioid for pain relief. While effective, it can cause side effects like dizziness or nausea, which are common with many opioids.

Overall, both treatments have been studied for safety, but buprenorphine may have fewer severe side effects compared to other opioids like hydromorphone.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about buprenorphine for treating pain from broken bones because it offers a unique approach compared to traditional pain relievers like hydromorphone or other opioids. Unlike these standard treatments, buprenorphine acts as a partial agonist on opioid receptors, which can provide pain relief with potentially fewer side effects and a lower risk of dependency. Additionally, buprenorphine's unique mechanism allows it to be effective at lower doses, potentially reducing the overall medication requirement while still effectively managing pain. This could make it a safer alternative for managing acute pain in fracture patients.

What evidence suggests that this trial's treatments could be effective for pain from broken bones?

Research has shown that buprenorphine, which participants in this trial may receive, can effectively manage pain, particularly in older adults. Studies have found that it reduces pain more effectively than some traditional opioids. For instance, one study found that buprenorphine significantly lowered pain scores compared to other opioids. It also has a good safety record, with fewer serious side effects. Compared to other opioids, buprenorphine often provides better pain relief and lasts longer. These findings suggest that buprenorphine could be a strong option for treating pain from broken bones. Meanwhile, the trial will compare hydromorphone, another treatment option, to assess its effectiveness in managing pain from broken bones.13467

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older who come to the emergency department with a recent broken bone and have moderate to severe pain. They must be able to give consent (or have someone do it for them).

Inclusion Criteria

I am able to give consent for my treatment or have someone who can decide for me.
* Emergency Department patient
I have a recent or suspected bone fracture.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either buprenorphine or hydromorphone for pain management after a fracture

48 hours
Continuous monitoring in the Emergency Department

Follow-up

Participants are monitored for adverse events and pain control effectiveness

30 days
Follow-up assessments at 4 hours, 8 hours, and 30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Buprenorphine
  • Hydromorphone

Trial Overview

The study compares two pain medications—buprenorphine (under the tongue) and hydromorphone (given by IV)—to see which works better and has fewer side effects in treating pain from fractures in older adults.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BuprenorphineExperimental Treatment1 Intervention
Group II: HydromorphoneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials
82
Recruited
35,600+

Citations

Transdermal Buprenorphine for Pain Management Following ...

Conclusion. This series suggests that transdermal buprenorphine is safe and effective in the management of pain following a neck of femur fragility fracture.

Comparison of the efficacy and safety of transdermal ...

Conclusion. TDB patch has demonstrated efficacy and safety in the treatment of post-operative pain following proximal femur fracture fixation surgery. It ...

Buprenorphine May Be Safe, Effective for Acute Pain in ...

In older adults, buprenorphine was found to more effectively manage pain than a control opioid in half of studies reviewed.

Buprenorphine for acute post-surgical pain - PMC

Day one shows 5.9 reductions in pain with 98% heterogeneity. The 3% more pain was reduced on day 2. The day 3 pooled pain reduction score was observed as 1.9%.

Buprenorphine versus full agonist opioids for acute ...

Conclusions Buprenorphine demonstrated superior efficacy in managing acute postoperative pain compared with FAOs, with a favorable safety profile and longer ...

865 A Systematic Review of Safety and Efficacy of ...

This systematic review aims to evaluate the safety and efficacy of transdermal buprenorphine patches for pain management in postoperative orthopaedic patients ...

The Effectiveness and Safety of Buprenorphine in Palliative ...

Buprenorphine is increasingly used for pain relief in palliative care settings due to its potent analgesic properties, favorable safety profile, and lower risk ...