Sedation Methods for Broken Bones Treatment

(DRIFT Trial)

Recruiting at 8 trial locations

Overseen By Candace Young, BS

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

Trial Summary

What is the purpose of this trial?

This protocol describes a multicenter, prospective randomized superiority trial comparing functional outcomes between children treated with sedated reduction versus no formal reduction.

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 data supports the effectiveness of the treatment for sedation methods in broken bones treatment?

Research shows that using sedation methods like ketamine or propofol for closed reduction (realigning broken bones without surgery) in children is effective, as it helps restore proper bone alignment and avoids the need for general anesthesia. Studies indicate that these methods are safe and do not lead to higher rates of complications or poor bone alignment after treatment. ^{1 2 3 4 5}

Is sedation for fracture treatment generally safe in humans?

Research on sedation for fracture treatment, especially in children, shows that it is generally safe when performed in emergency departments. Safety measures like monitoring oxygen levels are commonly used, but there are inconsistencies in how adverse events are defined and reported across studies. ^{1 2 4 6 7}

How does the treatment of closed reduction with sedation for broken bones differ from other treatments?

Closed reduction with sedation is unique because it involves realigning broken bones without surgery, using sedation to keep the patient comfortable and still during the procedure. This method is cost-effective and timely, often performed in emergency departments, and can use different sedation drugs like ketamine or propofol, which vary in duration and effects. ^{1 2 5 8 9}

Research Team

Jospeh Janicki, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Conscious sedation and reduction of fractures in the paediatric population: an orthopaedic perspective. [2022]

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

Outcomes of Pediatric Fractures Managed With Closed Reduction by Orthopaedic Residents in the Emergency Department. [2018]

3. France pubmed.ncbi.nlm.nih.gov

Pediatric fracture reduction in the emergency department. [2022]

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

Improving Efficiency and Communication around Sedated Fracture Reductions in a Pediatric Emergency Department. [2022]

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

Procedural Sedation With Ketamine Versus Propofol for Closed Reduction of Pediatric Both Bone Forearm Fractures. [2018]

6. Israel pubmed.ncbi.nlm.nih.gov

Sedation for Forearm Fracture Reduction in the Pediatric Emergency Department: Impact on Hospitalization and Length of Stay. [2023]

7. United States 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. [2019]

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

Closed Reduction of Pediatric Distal Radial Fractures and Epiphyseal Separations. [2022]

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

Intravenous sedation for the closed reduction of fractures in children. [2019]