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

Trial Summary

What is the purpose of this trial?

The purpose of this study to investigate post-operative pain control in pediatric patients with closed supracondylar humerus fracture who undergo closed reduction and percutaneous pinning. Currently, it is standard of care that patients receive a narcotic prescription for post-operative pain control. All patients will initially be seen in our pediatric urgent care and recruited at the time of surgery. Patients will be randomized to receiving acetaminophen and ibuprofen or acetaminophen and oxycodone. Parents will not be blinded to the acetaminophen but both investigators, parents and the patients will be blinded to the study drug (ibuprofen or oxycodone). Pain level will be assessed using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery to 1st post-op visit). This study is being conducted in hopes of reducing opioid prescription after surgical fixation of uncomplicated supracondylar humerus fractures if our study can show that patient's pain levels post-operatively and parent/patient satisfaction are unchanged or improved in the acetaminophen and ibuprofen arm.

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 data supports the effectiveness of the drugs Acetaminophen and Ibuprofen, Tylenol, Paracetamol, Advil, Motrin, Oxycodone, OxyContin, Roxicodone, Xtampza ER, Oxaydo, Tylox, Percodan, Percocet for managing post-operative pain in a broken arm?

Research shows that a combination of oxycodone and acetaminophen can effectively manage post-operative pain, as seen in studies involving hand and wrist surgeries. Additionally, acetaminophen combined with opioids like oxycodone has been shown to provide significant pain relief, although acetaminophen alone may also be adequate for some fracture-related pain. ^{1 2 3 4 5}

Is the combination of pain medications like acetaminophen, ibuprofen, and oxycodone safe for managing post-operative pain?

Research shows that combining medications like acetaminophen, ibuprofen, and oxycodone can effectively manage post-operative pain with a good safety profile. Common side effects include nausea, vomiting, headache, and dizziness, but these are usually mild to moderate. Using combinations can reduce the need for higher doses of opioids, which may improve safety. ^{1 6 7 8 9}

How does the drug combination of acetaminophen, ibuprofen, and oxycodone for post-operative pain in a broken arm differ from other treatments?

This drug combination is unique because it uses both non-opioid (acetaminophen and ibuprofen) and opioid (oxycodone) medications to manage pain, potentially reducing the need for higher doses of opioids alone, which can lead to fewer side effects and complications. The combination approach is similar to other studies that show combining different types of pain relievers can be more effective than using a single type of medication. ^{1 2 5 10 11}

Research Team

Mauricio Silva, MD

Principal Investigator

UCLA/OIC

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Multi-Modal Pain Control in Ambulatory Hand Surgery. [2018]

2. India 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). [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Bromfenac sodium, acetaminophen/oxycodone, ibuprofen, and placebo for relief of postoperative pain. [2019]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Pain Relief After Operative Treatment of an Extremity Fracture: A Noninferiority Randomized Controlled Trial. [2017]

6. Sweden 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. [2018]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Systemic multimodality postoperative analgesia in vascular surgery]. [2019]

8. England 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. [2019]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia]. [2013]

10. Turkey pubmed.ncbi.nlm.nih.gov

[The effectiveness of preemptive analgesic techniques on postoperative analgesia in patients undergoing open septorhinoplasty]. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Single fixed-dose oral dexketoprofen plus tramadol for acute postoperative pain in adults. [2023]