Sedation Methods for Broken Bones Treatment

(DRIFT Trial)

Recruiting at 28 trial locations

Overseen By Candace Young, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Physeal involvement, Open fracture, Neuromuscular, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 28

Duration: 6 weeks

334 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for treating broken bones in children's arms. It compares outcomes for children whose broken bones are set with sedation (to help them relax or sleep) versus those whose bones are placed in a cast without sedation. The study focuses on children aged 4 to 10 with a specific type of arm fracture that occurred less than 10 days ago. Children with this type of fracture who can adhere to a treatment plan may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding the best treatment options for children's arm fractures.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this protocol is safe for children?

Research has shown that using a cast to immobilize a broken bone is generally safe. A thumb spica cast, often applied for wrist fractures, is comfortable for most individuals. These casts are typically worn for six to ten weeks, and major issues rarely occur during this period. Most patients retain some arm and hand movement, aiding in daily activities.

For treatments involving bone realignment while the patient is relaxed, studies indicate that conscious sedation is often used and is generally safe. Minor side effects, such as drowsiness or nausea, may occur, but serious complications are rare. Conscious sedation eases the procedure and reduces pain. It is important to consult a doctor to understand personal risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two methods for treating broken bones, focusing on sedation. The experimental approach, non-sedated immobilization, avoids sedation entirely, using just a cast without the traditional reduction process. This could mean fewer risks associated with sedation, such as side effects or complications, and potentially faster recovery times. On the other hand, the formal reduction method involves conscious sedation for closed reduction, which is the current standard for many fractures, aiming for precise bone alignment and stabilization. The trial aims to uncover whether non-sedated immobilization can offer a safe and effective alternative, especially for patients who might be at risk from sedation.

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

Research has shown that using a cast to immobilize a broken bone can sometimes yield mixed results. One study found that only 43% of bones healed correctly after 14 weeks with this method. Other studies suggest that a thumb cast might not be as effective as other treatments. In this trial, one group of participants will receive non-sedated immobilization, which involves immobilizing the bone in a cast without reduction.

In contrast, another group will undergo formal reduction, which involves setting the bone back in place while the patient is sedated. This method often helps bones heal in the correct position and is generally considered more effective for proper alignment, leading to better recovery. While using a cast might be simpler, formal reduction could result in more accurate healing for broken bones. ^{6 7 8 9 10}

Who Is on the Research Team?

Jospeh Janicki, MD

Principal Investigator

Ann and Robert H. Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 4-10 with a specific type of broken wrist bone (distal radius fracture) that happened within the last 10 days. They must be able to undergo treatment in an OR or ED, and their parents need to consent and commit to the study's requirements. Children with growth plate involvement, open or pathological fractures, neuromuscular or metabolic diseases are excluded.

Inclusion Criteria

Willing to adhere to the immobilization regimen

I am between 4 and 10 years old.

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

My fracture affects the growth plate.

Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay.

I have an open fracture, a disease-related fracture, or a muscle or metabolic disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either immobilization in a cast without reduction or closed reduction under conscious sedation followed by casting

6 weeks

1 visit (in-person) for treatment initiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits at 3, 6, and 12 months

Long-term Follow-up

Participants are monitored for long-term outcomes and any late complications

36 months

Follow-up visits at 24 and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Immobilization
• Reduction

Trial Overview The study compares two ways of treating children's broken wrists: one group will have the bones set while sedated ('sedated reduction'), while another group won't have this procedure. The goal is to see which method leads to better use of the hand after healing.

How Is the Trial Designed?

Group I: Non-sedated Immobilization Experimental Treatment 1 Intervention

Immobilization in a cast without reduction

Group II: Formal Reduction Active Control 1 Intervention

closed reduction under conscious sedation followed by casting

Reduction is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Closed reduction for:

• Distal radius fractures
• Mildly displaced fractures

Approved in European Union as Closed reduction for:

• Distal radius fractures
• Mildly displaced fractures
• Pediatric fractures

Approved in Canada as Closed reduction for:

• Distal radius fractures
• Mildly displaced fractures

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

In a study of 165 pediatric patients with forearm fractures, those treated in the pediatric emergency department (PED) had a significantly lower hospitalization rate (6.3%) compared to those treated in the general trauma ED (GTED) (21.5%), indicating that sedation during closed reductions in the PED is more effective in preventing hospital admissions.

Although the median length of stay (LOS) in the PED was longer (237 minutes) than in the GTED (168 minutes), the benefits of reduced hospitalization rates suggest that the use of sedation in the PED is a safer and more effective approach for managing these injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedation for Forearm Fracture Reduction in the Pediatric Emergency Department: Impact on Hospitalization and Length of Stay. Abu-Omer, M., Chayen, G., Jacob, R.[2023]

In a study of 386 pediatric patients treated with conscious sedation for fracture reduction, 86.3% had successful outcomes without the need for repeat interventions, indicating that this method is effective for managing fractures in the emergency department.

While conscious sedation is a viable alternative to general anesthesia, 13.7% of patients required repeat interventions, highlighting the need for careful monitoring and follow-up after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conscious sedation and reduction of fractures in the paediatric population: an orthopaedic perspective. Yang, BW., Waters, PM.[2022]

The quality improvement initiative successfully reduced the mean length of stay in the pediatric emergency department for children undergoing sedation for long bone fracture reductions from 361 to 340 minutes, achieving a 5.8% decrease.

Interdisciplinary communication among providers improved significantly, with satisfaction increasing from 68% at baseline to 92% at 9 months post-implementation, indicating enhanced collaboration during the sedation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Efficiency and Communication around Sedated Fracture Reductions in a Pediatric Emergency Department. Paydar-Darian, N., Goldman, MP., Michelson, KA., et al.[2022]

A meeting of sedation experts identified significant gaps in the measurement of safety during procedural sedation research, highlighting that only 6 out of 133 reviewed studies used validated safety measures.

The experts recommended a set of core and supplemental safety measures to improve consistency in reporting adverse events, which will enhance the quality of safety data in future clinical trials and aid in systematic reviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations. Ward, DS., Williams, MR., Berkenbosch, JW., et al.[2019]

Closed reduction and cast immobilization for displaced distal radial fractures is a low-risk procedure that effectively promotes healing and alignment, with a high rate of union and minimal need for additional surgical interventions.

Post-reduction care is crucial, including monitoring for complications like carpal tunnel syndrome and ensuring proper cast application to avoid skin breakdown, with a recommended follow-up radiograph at 1 and 2 weeks to confirm maintained alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed Reduction of Pediatric Distal Radial Fractures and Epiphyseal Separations. Gohel, S., Baldwin, KD., Hill, JF.[2022]

In a study of 74 pediatric patients with forearm fractures, both ketamine and propofol sedation resulted in similar rates of unacceptable alignment after closed reduction, indicating that both sedation methods are effective for this procedure.

There were no significant differences in major sedation-related complications between the two sedation groups, although ketamine sedation required a longer duration and had a greater padding index compared to propofol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedural Sedation With Ketamine Versus Propofol for Closed Reduction of Pediatric Both Bone Forearm Fractures. Morrison, T., Carender, C., Kilbane, B., et al.[2018]

Children's bone remodeling ability allows for conservative treatment of limb fractures, and in cases of displaced fractures, closed reduction in the emergency room (ER) can avoid the need for general anesthesia and hospitalization.

The review highlights that while some complex fractures require immediate surgical intervention, ER reductions are safe and effective, with complication rates not higher than traditional methods, emphasizing the importance of surgeon experience and training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric fracture reduction in the emergency department. Bin, K., Rony, L., Henric, N., et al.[2022]

In a study of 838 pediatric fractures treated by orthopaedic residents, 95.3% of initial closed reductions were satisfactory, indicating a high success rate for this procedure in the emergency department.

Residents with more experience had a lower rate of unsatisfactory reductions (3.4%) compared to those on their first rotation (7.0%), suggesting that experience plays a crucial role in achieving successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Pediatric Fractures Managed With Closed Reduction by Orthopaedic Residents in the Emergency Department. Natarajan, V., Abebe, E., Dunlap, J., et al.[2018]

Intravenous sedation using a combination of meperidine (narcotic) and midazolam (benzodiazepine) was found to be safe and effective for closed reduction of fractures in 104 children, with a 92% success rate in initial procedures.

There were no serious complications such as apnea or cardiorespiratory issues, and 98% of parents reported satisfaction with the sedation method, indicating it is a reliable option for pediatric fracture treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous sedation for the closed reduction of fractures in children. Varela, CD., Lorfing, KC., Schmidt, TL.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10470239/

Postoperative Immobilization of Scaphoid Fractures Immobilization for 20 of the 23 subjects included a thumb spica splint or cast for an average of 11.2 weeks. The rate of bony union at 14 weeks was 43%, but was ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12043608/

Determining the success of clinical outcomes for thumb ... Overall, the use of a thumb cast has shown similar or worse clinical outcomes when compared to a no-thumb cast, which is indicative that ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/15589447221081864

The Effect Immobilization Mechanisms Have on ... Three studies compared immobilization constructs that included a gutter or spica component with constructs (1 above-elbow cast, 1 above-elbow ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023008472

Revolution in orthopedic immobilization materials This paper aims to present a comprehensive review on the technique of immobilization, existing orthopedic immobilization (casting and splinting) materials and ...

5. traumamon.com traumamon.com/article_99653_79695da584438f6c4c569d9d0069beed.pdf

The Effect of Long Arm Cast and Thumb Spica ... In this study, we aimed to compare the effectiveness and satisfaction in the methods of a long cast and thumb. Spica cast in the patients with ...

6. emedicine.medscape.com emedicine.medscape.com/article/80146-periprocedure

Thumb Spica Splinting Periprocedural Care A patient who has clinical evidence of a scaphoid injury on physical examination should be placed in a thumb spica splint and should receive close follow-up.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538525/

Thumb Spica Splinting - StatPearls - NCBI Bookshelf In the setting of a scaphoid fracture, using a long-arm thumb spica splint may lead to reduced union times in the first 4 to 6 weeks and ...

8. aafp.org aafp.org/pubs/afp/issues/2022/0300/p307.html

Thumb Spica Casts for Scaphoid Fractures The type of cast used does not appear to impact outcomes. A short arm cast allows the patient to have better function and mobility during immobilization ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5515607/

Functional Outcomes of 24-Hour Thumb Immobilization in ... A nondisplaced scaphoid waist fracture is usually treated with a below-elbow cast, most often immobilizing the thumb (thumb spica cast [TSC]). However, there is ...

10. journals.sagepub.com journals.sagepub.com/doi/10.1177/15691861251338448

Determining the success of clinical outcomes for thumb ... An immobilization time of approximately six to ten weeks is required for conservative treatment of nondisplaced or minimally displaced scaphoid ...