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

160 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug for pain management in supracondylar humerus fractures?

Research suggests that children who did not receive opioids reported similar postoperative pain levels compared to those who did, indicating that non-opioid options like acetaminophen and ibuprofen can be effective for managing pain after supracondylar humerus fracture surgery. ^{1 2 3 4 5}

Is acetaminophen safe for pain management in humans?

Research shows that acetaminophen, also known as paracetamol, is generally well-tolerated and safe for managing pain in humans, with studies indicating no significant adverse effects when used appropriately. ^{1 6 7 8 9}

How does the drug treatment for supracondylar humerus fractures differ from other options?

This treatment uses a combination of acetaminophen, hydrocodone/acetaminophen, and ibuprofen, which offers a balance between non-opioid and opioid pain relief. It aims to manage pain effectively while potentially reducing the need for higher opioid doses, addressing concerns about opioid overuse in children. ^{1 2 3 4 10}

What is the purpose of this trial?

This purpose of this study is to determine the efficacy of nonopioid versus opioid analgesic regimens following surgical fixation of Gartland Type III Supracondylar Humoral Fractures (SCHFs) to assist in the development of a standard outpatient pain management regimen in the treatment of these injuries.

Eligibility Criteria

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

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

I have a specific type of shoulder fracture that hasn't moved out of place.

Patients with known allergy to medications used in this study

Timeline

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)

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

References

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

Postoperative pain control after supracondylar humerus fracture fixation. [2020]

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

Opioid Analgesia Compared with Non-Opioid Analgesia After Operative Treatment for Pediatric Supracondylar Humeral Fractures: Results from a Prospective Multicenter Trial. [2023]

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

Pain Control and Medication Use in Children Following Closed Reduction and Percutaneous Pinning of Supracondylar Humerus Fractures: Are We Still Overprescribing Opioids? [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Methods to reduce opioid use during surgical treatment of pediatric supracondylar fractures - a pilot study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Perioperative use of metamizole and other nonopioid analgesics in children : Results of a survey]. [2020]

6. France pubmed.ncbi.nlm.nih.gov

[Evaluation of the analgesic effect of UP 341-01 in patients presenting with acute pain in ORL]. [2013]

7. France pubmed.ncbi.nlm.nih.gov

[Physico-chemical stability and sterility of non-opioid analgesics in solution]. [2016]

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

Single-dose vicoprofen compared with acetaminophen with codeine and placebo in patients with acute postoperative pain after third molar extractions. [2020]

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

A comparison of the efficacy and tolerability of diflunisal and dextropropoxyphene napsylate with acetaminophen in the management of mild to moderate pain after arthroscopy of the knee. [2013]

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

Perioperative Ketorolac for Supracondylar Humerus Fracture in Children Decreases Postoperative Pain, Opioid Usage, Hospitalization Cost, and Length-of-Stay. [2019]