Pain Control Alternatives for Broken Bones

Overseen By Dr. Ellen Lutnick Lutnick, MD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: State University of New York at Buffalo

Disqualifiers: Age, BMI, ASA class, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to manage pain for children with broken wrist bones (distal radius fractures). Researchers compare full sedation using ketamine with two other methods: a hematoma block (numbing the area) combined with either minimal ketamine or intranasal fentanyl (a strong pain reliever given through the nose). The goal is to determine which method is most effective and safest for pain control. Children aged 3 to 17 who need their broken wrist set in the emergency room may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to important research on effective pain management for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that using ketamine to help children with broken bones, such as the radius, is safe. It eases pain and is cost-effective. Research indicates that a low dose of ketamine effectively manages fracture pain and is well-tolerated by children.

Intranasal fentanyl is generally used for quick pain relief. Although detailed information about its safety specifically for broken bones in children is limited, fentanyl is widely used in medical settings for pain management and is considered safe when administered correctly.

Overall, both treatments in this trial have good safety records in similar situations, making them promising options for managing pain in broken bones. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for broken bones because they offer new ways to manage pain during procedures like fracture reductions, especially for kids. Unlike traditional methods that mainly rely on opioids like morphine, these approaches use different combinations of ketamine, fentanyl, and lidocaine. Full ketamine sedation offers a powerful alternative with a different mechanism of action, acting as a dissociative anesthetic to manage pain without the typical opioid side effects. Meanwhile, the combination of intranasal fentanyl and a hematoma block provides a less invasive option, while another arm uses minimal ketamine alongside a hematoma block for targeted pain relief. These approaches aim to reduce pain effectively and safely, potentially offering quicker recovery times and fewer side effects.

What evidence suggests that this trial's treatments could be effective for pain control in broken bones?

This trial will compare different pain management strategies for children with broken wrists. Studies have shown that full ketamine sedation, one treatment option in this trial, greatly reduces pain and is both safe and cost-effective. Another arm of this trial will evaluate a low dose of ketamine combined with other pain relief methods, such as a hematoma block, which research suggests effectively manages pain. Additionally, the trial will assess a nasal spray form of fentanyl with a hematoma block, which has shown promise in controlling pain without requiring full sedation. These treatments offer various ways to effectively manage pain during the fracture-setting process. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for pediatric patients who have a distal radius fracture (a type of broken bone near the wrist) that needs to be set back into place. The study is looking for children who can safely receive pain management treatments.

Inclusion Criteria

My child needs treatment for a broken wrist bone near the hand.

I am between 3 and 17 years old.

I am a child being seen in the emergency department.

Exclusion Criteria

My child is under 3 years old.

My child cannot be sedated due to high BMI, health risks, or pregnancy.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either full ketamine sedation, hematoma block with minimal ketamine, or hematoma block with intranasal fentanyl for distal radius fracture reduction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain control efficacy and patient satisfaction scores 1 hour after fracture reduction

1 hour

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fentanyl
• Ketamine
• Lidocaine

Trial Overview The study tests how well different pain control methods work in kids with these fractures. One group gets a hematoma block and minimal ketamine, another gets the same block plus intranasal fentanyl, and there's also a standard full sedation with ketamine group.

How Is the Trial Designed?

Group I: Full ketamine sedation Active Control 1 Intervention

Including group of patients treated with full ketamine sedation in setting of distal radius fracture reduction

Group II: hematoma block/intranasal fentanyl Active Control 1 Intervention

Including control group of patients treated with intranasal fentanyl and hematoma block, utilized in the setting of distal radius fractures in pediatric patients requiring reduction

Group III: Hematoma block/minimal ketamine pain control Active Control 1 Intervention

Including group of patients treated with hematoma block/minimal ketamine pain control (. 0.25mg/kg) for distal radius fracture reduction in pediatric patients requiring reduction

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675725004644

Pain management with ketamine procedural sedation and ... Ketamine with PSA and IB significantly reduces pain in distal radius and ulna fractures in the first 60 min, facilitating fracture reduction. It provides ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5859200/

Use of ketamine sedation for the management of displaced ... Ketamine procedural sedation in the paediatric population is a safe and cost effective method for the treatment of displaced fractures of the radius and ulna.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07120763

Pain Control Alternatives in Pediatric Patients With Distal ... Pain control efficacy, Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization ...

4. patlynk.com patlynk.com/trial/NCT07120763

Pain Control Methods for Children with Distal Radius ... Pain control efficacy. Including control group of patients treated with full ketamine sedation in setting of distal radius fracture reduction; randomization ...

5. tandfonline.com tandfonline.com/doi/abs/10.2217/pmt-2023-0030

Mini-Dose Bier's Block VS Systemic Analgesia in Distal ... Conclusion: Mini-dose IVRA technique contributes to better hemodynamic stability, without prominent adverse events, and leads to significant pain control and ...

6. actaorthopaedica.be actaorthopaedica.be/assets/2463/22-Jordan.pdf

A comparison of ketamine sedation and general ... We conclude that ketamine sedation achieves comparable treatment outcomes to general anaesthesia whilst using fewer resources. Keywords : ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1302/1863-2548.13.190013

Conscious sedation and reduction of fractures in the ... The rate of conscious sedation and reduction by diagnosis was highest for both-bone forearm fractures (81.3%, 100/123) and distal radius fractures (63.5%, 167/ ...