Pain Management for Broken Arm

Enrolling by invitation at 2 trial locations

Overseen By Callie Bridges

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Baylor College of Medicine

Must not be taking: Chronic NSAIDs, Opioids

Disqualifiers: Open wounds, Polytrauma, Neurologic deficit, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: up to 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if over-the-counter pain medications like ibuprofen and acetaminophen manage pain as effectively as a combination of ibuprofen and the opioid hydrocodone, specifically after surgery for elbow fractures in children. If these non-opioid options prove effective, fewer opioid prescriptions may be needed, reducing risks associated with opioid use. Children who have had a specific type of elbow fracture treated with a standard surgical procedure and can follow up at Texas Children's Hospital might be suitable for this study. As a Phase 4 trial, this research seeks to understand how the already FDA-approved treatment benefits more patients, offering a chance to contribute to safer pain management strategies for children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients who are already on chronic NSAID or opioid medication before the injury.

What is the safety track record for these treatments?

Research has shown that ibuprofen and acetaminophen are usually safe and effective for pain relief. Studies have found that combining ibuprofen with acetaminophen can relieve pain in children with broken arms. Common side effects include sleepiness, nausea, and vomiting, but these are usually mild.

For more severe pain, hydrocodone with acetaminophen is effective. This option is often used when other pain medicines don't work. However, opioids like hydrocodone can cause more serious side effects, such as dizziness and constipation, and there is a risk of dependence.

Both treatment options have been tested and used widely, indicating safety when used as directed. Following dosage instructions from healthcare providers is important to reduce any risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for pain management in broken arms because they offer alternatives to traditional opioid use. Unlike standard treatments that often rely heavily on opioids for severe pain relief, this approach focuses on using ibuprofen as the first line of defense, supplemented by either a non-opioid option (acetaminophen) or a reduced opioid option (hydrocodone/acetaminophen) only for breakthrough pain. This method could potentially reduce the risk of opioid dependency and side effects, providing effective pain relief while minimizing the use of stronger medications.

What evidence suggests that this trial's treatments could be effective for pain management in children with broken arms?

Research has shown that using ibuprofen with acetaminophen can relieve pain as well as, or even better than, opioid medications like hydrocodone/acetaminophen for children with broken arms. In this trial, one group will receive non-opioid pain management with ibuprofen as the first line of treatment and acetaminophen as needed for breakthrough pain. Another group will receive opioid pain management with ibuprofen as the first line of treatment and hydrocodone/acetaminophen as needed for breakthrough pain. Studies have found that ibuprofen alone works just as well as acetaminophen with codeine, a common opioid, for treating pain in children with arm injuries. Combining ibuprofen and acetaminophen provides effective pain relief with fewer side effects than opioid treatments. This approach allows for effective pain management without the risks associated with opioids. ^{3 5 6 7 8}

Who Is on the Research Team?

Scott Rosenfeld, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for children with specific elbow fractures (Gartland type II or III) treated surgically, who can return to Texas Children's Hospital for follow-up. Participants must speak English or Spanish. It excludes those with open wounds, multiple injuries, nerve/blood vessel damage, intellectual delays affecting pain reporting, bone healing disorders like osteogenesis imperfecta, allergies to the medications used in the study, severe kidney disease, prior chronic NSAID or opioid use before injury.

Inclusion Criteria

Patients expected to follow up at Texas Children's Hospital

I have a severe elbow fracture.

I had a fracture fixed without surgery, using pins.

Exclusion Criteria

I have been taking NSAID or opioid medications regularly before getting injured.

Patients with injury from suspected non-accidental trauma

I have a condition that affects how my bones heal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either opioid or non-opioid pain management plans and monitored for pain relief effectiveness

up to 3 weeks

Post-operative visits with the surgeon

Follow-up

Participants are monitored for safety and effectiveness after treatment, with pain medication usage and pain severity recorded daily

up to 3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen
• Hydrocodone/acetaminophen
• Ibuprofen
• Post-operative Pain Management

Trial Overview

The study compares two pain management strategies after elbow surgery in children: one using over-the-counter drugs ibuprofen and acetaminophen versus another combining ibuprofen with an opioid (hydrocodone/acetaminophen). The goal is to see if non-opioid meds are as effective as opioids for post-surgery pain relief which could reduce early exposure to opioids and their circulation.

How Is the Trial Designed?

Group I: Non-Opioid Pain Management Experimental Treatment 2 Interventions

Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.

Group II: Opioid Pain Management Active Control 2 Interventions

Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.

Acetaminophen is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Tylenol for:

• Pain relief
• Fever reduction

Approved in European Union as Paracetamol for:

• Pain relief
• Fever reduction

Approved in Canada as Tylenol for:

• Pain relief
• Fever reduction

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

A fixed-dose combination of acetaminophen (APAP) and ibuprofen (IBP) was found to be well tolerated in a study involving 922 patients, with adverse events similar to or lower than those seen with either drug alone or placebo.

The combination therapy provided superior pain relief compared to monotherapy, while maintaining a strong safety profile without increasing the risk of common adverse events like gastrointestinal issues or postoperative bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated safety analysis of combined acetaminophen and ibuprofen (Maxigesic &#174; /Combogesic&#174;) in adults. Aitken, P., Stanescu, I., Playne, R., et al.[2023]

NSAIDs are generally more effective than paracetamol for pain relief in dental surgery, while their effectiveness is similar in major and orthopedic surgeries, indicating that the choice of pain management may depend on the type of surgery.

Paracetamol is a safer alternative to NSAIDs due to its lower incidence of adverse effects, making it a preferred option for high-risk patients; combining paracetamol with NSAIDs may enhance pain relief, but more research is needed to assess potential side effects from this combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. Hyllested, M., Jones, S., Pedersen, JL., et al.[2022]

Tramadol/paracetamol (TRM+P) has the highest reporting rate of adverse drug reactions (ADRs) among the three weak opioid analgesics studied, with a rate of 44.5 per 100,000 person-years, compared to 24.9 for dextropropoxyphene/paracetamol (DXP+P) and 12.5 for codeine/paracetamol (COD+P).

Dextropropoxyphene/paracetamol (DXP+P) is associated with a higher frequency of hepatobiliary ADRs and a worse safety profile compared to codeine/paracetamol (COD+P), despite having a lower overall reporting rate of ADRs than tramadol/paracetamol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol). Tavassoli, N., Lapeyre-Mestre, M., Sommet, A., et al.[2021]

The fixed-dose combination (FDC) of ibuprofen (250 mg) and acetaminophen (500 mg) demonstrated superior pain relief compared to individual doses of ibuprofen (250 mg) and acetaminophen (650 mg) in two phase 3 studies involving a total of 691 patients, with significant efficacy observed within the first hour and lasting over 8 hours.

The FDC was well tolerated, showing the lowest rates of adverse events compared to the individual components, making it a promising non-opioid option for managing acute dental pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Single and Multiple Doses of a Fixed-dose Combination of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: Results From 2 Phase 3, Randomized, Parallel-group, Double-blind, Placebo-controlled Studies. Searle, S., Muse, D., Paluch, E., et al.[2021]

Intravenous paracetamol (1 g) has been shown to provide significantly better pain relief than placebo in adults after surgeries, and it also reduces the need for opioid pain relief, making it an effective first-line treatment.

In pediatric patients, intravenous paracetamol (15 mg/kg) demonstrated similar pain relief and fever reduction compared to propacetamol (30 mg/kg), with a good safety profile and very rare adverse reactions (<1/10,000).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous paracetamol (acetaminophen). Duggan, ST., Scott, LJ.[2022]

In a study involving 425 patients with postherniorrhaphy pain, 400 mg of ibuprofen was found to be more effective than a placebo and as effective as a compound analgesic containing acetylsalicylic acid, caffeine, and codeine.

The side effects of ibuprofen and the other medications tested were negligible, suggesting that ibuprofen is a safe and suitable alternative for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relief of postoperative pain by ibuprofen: a report of two studies. Iles, JD.[2020]

In a study of 8677 patients, the use of analgesics like paracetamol, aspirin, and ibuprofen showed that the main risk factors for serious adverse events (SAE) included the type of pain being treated and the number of other medications taken, with higher risks associated with more medications.

Patients taking aspirin had a higher risk of SAE compared to those taking paracetamol, while ibuprofen was associated with fewer gastrointestinal adverse events, highlighting the importance of medication choice and patient history in managing pain safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events in analgesic drug users: results from the PAIN study. Moore, N., Charlesworth, A., Van Ganse, E., et al.[2013]

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has issued a warning about the serious risks associated with the combination of codeine and ibuprofen, particularly concerning renal and gastrointestinal harms.

This warning highlights the need for careful consideration of the safety profile of this medication combination, emphasizing potential adverse effects that could impact patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety warning: combination products containing codeine and ibuprofen. [2023]

A survey of 1,500 anesthesia departments in Germany revealed that rectally administered acetaminophen is the standard for postoperative pain management in pediatric patients, with an increased use of opioids compared to past practices.

Despite the availability of various pain management options, 71.1% of anesthesiologists believe that postoperative pain management for children still requires improvement, indicating a need for better strategies and techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative pain therapy in pediatrics. Results of a representative survey in Germany]. Bremerich, DH., Neidhart, G., Roth, B., et al.[2019]

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