Opioid vs Non-Opioid Pain Management for Supracondylar Humerus Fractures

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Children's Mercy Hospital Kansas City

Must not be taking: Opioids, NSAIDs

Disqualifiers: Additional injuries, Cognitive issues, 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: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage pain after surgery for a specific upper arm fracture near the elbow, known as a Gartland Type III Supracondylar Humerus Fracture. Researchers compare the effectiveness of non-opioid painkillers, such as acetaminophen and ibuprofen, with opioid painkillers, like hydrocodone combined with acetaminophen. The goal is to determine which option provides better pain relief after surgery. Children who have experienced this fracture and meet certain criteria, such as treatment at Children's Mercy Hospital and the absence of other major injuries or medical conditions, may be suitable candidates for this trial. As a Phase 4 trial, the research involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes patients who are regularly treated with opioids or NSAIDs (non-steroidal anti-inflammatory drugs). This suggests that if you are on these medications regularly, you may not be eligible to participate.

What is the safety track record for these treatments?

Research shows that both treatment options under study—acetaminophen with ibuprofen and hydrocodone with acetaminophen and ibuprofen—are generally safe when used correctly.

Studies have shown that the combination of acetaminophen and ibuprofen is effective and well-tolerated for managing pain after surgery for certain fractures. Research found that this combination works as well as stronger painkillers in children, without the risk of addiction or severe side effects.

Studies suggest that hydrocodone combined with acetaminophen and ibuprofen is also effective for pain relief. However, it carries a higher risk of side effects like drowsiness and potential for misuse because it includes an opioid, a strong painkiller that can be addictive.

Both treatments should be used as directed to avoid problems. For instance, excessive acetaminophen over time can harm the liver. Following dosing instructions carefully for all medications is crucial to ensure safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for supracondylar humerus fractures traditionally involve opioids like hydrocodone combined with acetaminophen to manage pain. But researchers are excited about using a non-opioid approach that combines acetaminophen with ibuprofen instead. This alternative is unique because it avoids opioids, reducing the risk of addiction and side effects associated with opioid use. Additionally, the combination of acetaminophen and ibuprofen can offer effective pain relief without the sedation often linked with opioids, making it a potentially safer option for managing pain in patients.

What evidence suggests that this trial's treatments could be effective for supracondylar humerus fractures?

This trial will compare opioid and non-opioid pain management strategies for supracondylar humerus fractures. Research has shown that non-opioid pain relievers, such as a combination of acetaminophen and ibuprofen, can ease pain in children after elbow fracture surgery as effectively as opioids. Participants in the non-opioid group will receive acetaminophen and ibuprofen, which studies have found effectively manage pain, with noticeable improvement by the fifth day after surgery. The control group will receive hydrocodone with acetaminophen and ibuprofen, which also provides effective pain relief but does not surpass non-opioid options. Both methods offer good pain relief, but non-opioids are safer due to fewer risks, such as addiction. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone surgery to fix a type of broken arm known as Gartland Type III supracondylar humerus fractures. The study aims to find the best pain management after surgery.

Inclusion Criteria

My child has a severe, fully displaced elbow fracture.

Patients presenting to Children's Mercy Hospital

I am between 4 and 9 years old.

Exclusion Criteria

Patients with known allergy to medications used in this study

Patients with underlying medical issues affecting cognitive status

I am either younger than 4 years or older than 10 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either nonopioid or opioid analgesic regimens following surgical fixation of Gartland Type III supracondylar humerus fractures

5 days

Daily monitoring (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with pain levels and parent satisfaction assessed

5 days

Daily assessments (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen
• Hydrocodone/acetaminophen
• Ibuprofen

Trial Overview The study is testing the effectiveness of different pain relief medications post-surgery: Hydrocodone/acetaminophen (an opioid combo), Ibuprofen, and Acetaminophen (both non-opioids).

How Is the Trial Designed?

Group I: Experimental Group (nonopioid group): Experimental Treatment 2 Interventions

Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours

Group II: Control Group (opioid group) Active Control 2 Interventions

Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN

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?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

The study confirmed that mixtures of non-opioid analgesics (paracetamol with ketoprofen, paracetamol with nefopam, and ketoprofen with nefopam) remain chemically stable and sterile for at least 24 hours.

These findings support the safe use of these analgesic combinations in a single ready-to-use solution for effective postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physico-chemical stability and sterility of non-opioid analgesics in solution]. Troïtzky, A., Tirault, M., Lefeuvre, S., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10695340/

Opioid Analgesia Compared with Non ... Conclusions: Non-opioid analgesia following CRPP for pediatric supracondylar humeral fractures was equally effective as opioid analgesia. When ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03759028

NCT03759028 | Supracondylar Post-Operative Pain Study This is a double-blinded, randomized controlled trial comparing the analgesic efficacy between acetaminophen and ibuprofen versus acetaminophen and oxycodone ...

3. orthobuzz.jbjs.org orthobuzz.jbjs.org/2023/12/11/analgesia-after-pediatric-supracondylar-humeral-fractures-its-time-to-shift-our-habits/

Analgesia After Pediatric Supracondylar Humeral Fractures Data from this study indicate that non-opioid analgesia is effective in controlling postoperative pain in our pediatric patients after CRPP of supracondylar ...

4. publications.aap.org publications.aap.org/aapgrandrounds/article/51/3/31/196719/Opioids-vs-Non-opioids-After-Humeral-Fracture

Opioids vs Non-opioids After Humeral Fracture Surgery The authors conclude that opioid analgesia was not significantly superior to non-opioid treatment in children following CRPP for supracondylar humeral ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33044375/

Pain Control and Medication Use in Children Following ... On average, pain scores were highest on postoperative day 1 (average 5/10) and decreased to clinically unimportant levels (<1) by postoperative day 5.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8464945/

NSAID Use and Effects on Pediatric Bone Healing By the 10–12 week appointment, 98% of control and 100% of NSAID patients had healed fractures, and the 6-month follow-up demonstrated 100% ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22706458/

Postoperative pain control after supracondylar humerus ... Conclusions: Acetaminophen is as effective as narcotic analgesics for providing pain control after supracondylar fracture surgery in children and is ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05640674

Post-operative Pain Management in Children With ... There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: ...

9. jpp.mums.ac.ir jpp.mums.ac.ir/article_18731_a5489227ecef4abccc054354073c8719.pdf

The Analgesic Effects of Oral Acetaminophen vs. Ibuprofen ... This study was designed to compare the analgesic effects of oral ibuprofen with those of the acetaminophen in children with supracondylar ...