Pain Management Medications for Post-Operative Pain in Broken Arm

Overseen By Johnathan You, BS

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Los Angeles

Disqualifiers: Vascular injury, Neurologic deficit, Pathologic fractures, 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: 4

Duration: 1 week

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two pain management options for children who have had a type of broken arm fixed through common surgery. It compares the effectiveness of acetaminophen combined with either ibuprofen or oxycodone (an opioid pain medication) in managing post-surgery pain. The goal is to determine if ibuprofen can provide the same pain relief as oxycodone, potentially reducing the need for opioids. Children who have had their supracondylar humerus fracture (a break near the elbow) treated surgically might be suitable for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective. This research aims to understand how it benefits more patients, offering a chance to contribute to valuable insights.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves specific pain medications, it's best to discuss your current medications with the trial team to ensure there are no interactions.

What is the safety track record for these treatments?

Research shows that taking acetaminophen and ibuprofen together is generally safe for pain relief. Studies indicate they are commonly used and effective for reducing pain after surgery. At recommended doses, they are well-tolerated, making them a popular choice for managing post-surgery pain.

Oxycodone is another option for relieving acute pain. It is stronger, about two to three times more powerful than codeine. While effective, it can have serious side effects if not used properly, especially in children or those unfamiliar with strong pain medications. However, research shows that when used correctly, oxycodone can safely provide effective pain relief after surgery.

Both treatments have been widely used and are considered safe when directions are followed. Always adhere to medical advice and dosing guidelines to minimize risks. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for post-operative pain in broken arms because they explore non-opioid alternatives and optimized dosing strategies. The use of ibuprofen as a breakthrough pain option alongside acetaminophen provides a promising method to manage pain without relying on opioids, which are commonly used but have a high potential for addiction. In contrast, the oxycodone arm still includes an opioid but aims to minimize its use by combining it with acetaminophen, potentially reducing the overall opioid dose needed. This trial offers insights into effective pain management strategies while addressing concerns over opioid dependency.

What evidence suggests that this trial's treatments could be effective for post-operative pain in broken arms?

Research has shown that taking acetaminophen with ibuprofen, which participants in one arm of this trial may receive, can effectively relieve pain after surgery. Studies have found that this combination can provide pain relief similar to or even better than some opioids, such as morphine, but without the same risk of side effects. Specifically, one study showed that this combination works better than using either acetaminophen or ibuprofen alone for managing pain.

In another arm of this trial, participants may receive oxycodone, a strong painkiller known to be two to three times more powerful than codeine. It has effectively relieved acute pain after surgery in many patients. Both treatment options effectively manage pain after surgery, though the choice might depend on balancing pain relief with potential side effects. ^{1 3 5 6 7}

Who Is on the Research Team?

Mauricio Silva, MD

Principal Investigator

UCLA/OIC

Are You a Good Fit for This Trial?

This trial is for children with certain types of elbow fractures (Type II and III supracondylar humerus fractures) that have been treated surgically. It's not suitable for kids with additional injuries, vascular or nerve damage, swelling needing hospitalization, allergies to the pain meds being tested, or those who can't use the Faces Pain Scale due to developmental delays.

Inclusion Criteria

I have a type II or III break in the bone above my elbow.

I have a fracture in the bone above my elbow.

I have a broken bone above my elbow that hasn't pierced the skin.

Exclusion Criteria

I have fractures and other injuries from a major accident.

Known history of allergies to acetaminophen, ibuprofen or oxycodone

History of suspected child abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive acetaminophen and either ibuprofen or oxycodone for post-operative pain control

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen and Ibuprofen
• Oxycodone

Trial Overview The study compares two post-surgery pain management approaches in children: one combines acetaminophen (a common over-the-counter pain reliever) with ibuprofen (another OTC anti-inflammatory), while the other pairs acetaminophen with oxycodone (a stronger prescription opioid). The effectiveness will be measured by how well they control pain and parent/patient satisfaction.

How Is the Trial Designed?

Group I: Ibuprofen Experimental Treatment 2 Interventions

This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed ibuprofen for breakthrough pain (liquid oral medication, 10mg/kg/dose every 8 hours as needed, max dose 40mg/kg/day).

Group II: Oxycodone Active Control 2 Interventions

This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed oxycodone for breakthrough pain (liquid oral medication, 0.1mg/kg/dose every 6 hours as needed).

Acetaminophen and Ibuprofen 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 United States as Advil for:

• Pain relief
• Inflammation reduction
• Fever reduction

Approved in United States as Motrin for:

• Pain relief
• Inflammation reduction
• Fever reduction

Approved in Canada as Paracetamol and Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation reduction

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

In a study of 52 patients recovering from extremity fracture surgery, acetaminophen alone was found to be noninferior to a combination of acetaminophen and tramadol for pain relief, with similar satisfaction scores (8.3 vs. 8.5).

Given that tramadol can have more side effects and potential for addiction, the findings support using acetaminophen as the primary pain management option after such surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Relief After Operative Treatment of an Extremity Fracture: A Noninferiority Randomized Controlled Trial. Helmerhorst, GTT., Zwiers, R., Ring, D., et al.[2017]

In a study of 60 patients undergoing elective septorhinoplasty, preincisional intravenous dexketoprofen trometamol significantly reduced postoperative pain compared to acetaminophen and no analgesic, as indicated by lower Visual Analogue Scale (VAS) scores.

Patients receiving dexketoprofen trometamol required less postoperative tramadol for pain management than those receiving acetaminophen or no analgesic, highlighting its superior efficacy in early postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of preemptive analgesic techniques on postoperative analgesia in patients undergoing open septorhinoplasty]. Keskioğlu, İ., Aktay İnal, M., Özlü, O.[2018]

This study aims to determine if acetaminophen alone is as effective as a combination of acetaminophen and oxycodone for pain relief after non-operative treatment of limb fractures, involving 1226 participants over 14 days.

The trial is designed to provide evidence for a safer pain management strategy, potentially reducing reliance on opioids while still effectively managing pain in patients with limb fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of acetaminophen with and without oxycodone for analgesia in non-operative treatment of extremity fractures in adults: protocol for a double-blind randomized clinical trial. Gao, T., Zhu, H., Zhang, C., et al.[2023]

In a study of 79 patients undergoing thumb carpometacarpal arthroplasty or distal radius ORIF, the combination of oxycodone, acetaminophen, and ketorolac showed a trend towards better postoperative pain control and reduced opioid usage compared to other regimens.

Although not statistically significant, the group receiving oxycodone, acetaminophen, and ketorolac experienced fewer complications, suggesting that this combination may enhance safety and efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Modal Pain Control in Ambulatory Hand Surgery. Harrison, RK., DiMeo, T., Klinefelter, RD., et al.[2018]

A systematic review of five randomized controlled trials found that combining non-selective NSAIDs with paracetamol provides significantly better pain relief after oral surgery compared to using either drug alone.

While mild to moderate adverse events like nausea and headache were reported across treatment groups, the combination of ibuprofen and paracetamol showed fewer side effects compared to ibuprofen alone, suggesting it could be a safer option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combination of non-selective NSAID 400 mg and paracetamol 1000 mg is more effective than each drug alone for treatment of acute pain. A systematic review. Alexander, L., Hall, E., Eriksson, L., et al.[2018]

In a study of 100 patients undergoing upper limb orthopedic surgery, intravenous Paracetamol (15 mg/kg) provided effective pain relief compared to both intramuscular Piroxicam (0.4 mg/kg) and placebo, with significant differences in pain scores.

The combination of Paracetamol and Piroxicam did not show a significant advantage over Paracetamol alone in managing postoperative pain, suggesting that Paracetamol may be sufficient for effective analgesia in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between paracetamol, piroxicam, their combination, and placebo in postoperative pain management of upper limb orthopedic surgery (a randomized double blind clinical trial). Khalili, G., Salimianfard, M., Zarehzadeh, A.[2020]

In a study of 53 patients who underwent surgeries on the aorta and lower extremities, various combinations of non-narcotic analgesics were evaluated for effective postoperative pain relief, showing that multimodal regimens can provide good analgesia without narcotics.

The combination of paracetamol with tramadol not only led to a quicker onset of pain relief but also reduced the need for tramadol, making it a safer option for patients at high risk for complications from non-steroidal anti-inflammatory drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systemic multimodality postoperative analgesia in vascular surgery]. Kazennov, VV., Shishkin, MN., Amerov, DB.[2019]

The new oxycodone 10-mg/acetaminophen 325-mg formulation (Percocet) was found to be more effective than a higher dose of oxycodone alone in managing acute pain after oral surgery, based on a study of 141 patients.

This combination not only provided faster pain relief but also resulted in fewer treatment-related side effects, highlighting its potential as a safer alternative for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. Gammaitoni, AR., Galer, BS., Bulloch, S., et al.[2019]

In a study involving 238 patients with pain from abdominal gynecologic surgery, bromfenac (50 or 100 mg) provided pain relief that was at least as effective as acetaminophen/oxycodone, but with a longer duration of action.

Bromfenac also resulted in a lower rate of remedication compared to acetaminophen/oxycodone and ibuprofen, which was found to be less effective overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bromfenac sodium, acetaminophen/oxycodone, ibuprofen, and placebo for relief of postoperative pain. Johnson, GH., Van Wagoner, JD., Brown, J., et al.[2019]

In a study of 53 patients who underwent surgery on the infrarenal aorta and large vessels, various combinations of nonopioid drugs were tested for postoperative pain relief, all showing effective analgesic results.

The combination of paracetamol with tramadol not only provided faster pain relief but also reduced the need for tramadol, making it a safer option for patients at higher risk of ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia]. Kazennov, VV., Shishkin, MN., Amerov, DB., et al.[2013]

A single oral dose of dexketoprofen (25 mg) combined with tramadol (75 mg) provided significant pain relief for 66% of participants in acute postoperative pain, compared to only 32% with placebo, indicating a number needed to treat (NNT) of 3.0, which is comparable to other effective analgesics.

The combination of dexketoprofen and tramadol had a low incidence of adverse events, primarily mild to moderate nausea and dizziness, suggesting it is a safe option for pain management in postoperative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fixed-dose oral dexketoprofen plus tramadol for acute postoperative pain in adults. Derry, S., Cooper, TE., Phillips, T.[2023]

Citations

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Comparing the efficacy of intravenous morphine versus ... The study findings suggest that ibuprofen and its combination with acetaminophen have similar or better analgesic effects compared to morphine in patients with ...

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Pain medicines after surgery Pain medicines and anesthesia can control pain after surgery and lead to faster healing.

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An open-label, multi-center, single arm, multiple dose study Repeated doses of the FDC were found to be safe and well tolerated in patients treated for acute pain following orthopedic or plastic surgery over an exposure ...