Standardized Anesthesia Protocol for Le Fort Fracture Surgery

Overseen By Robin Yang, MD, DDS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Contraindications to anesthetic protocol

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hope this will help to minimize unnecessary postoperative pain management, inpatient stay, and long-term morbidity and mortality in these patients.

Do I need to stop my current medications for the trial?

The protocol does not specify if you need to stop your current medications.

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.

What data supports the idea that Standardized Anesthesia Protocol for Le Fort Fracture Surgery is an effective treatment?

The available research shows that improvements in pediatric anesthesia outcomes have been achieved through advances in safety science, professional standardization, and organization. These improvements suggest that standardized protocols, like the one used for Le Fort Fracture Surgery, can lead to better outcomes. Although specific data on this treatment is not provided, the emphasis on safety, quality care, and prevention of complications in pediatric anesthesia indicates that such protocols are effective in improving surgical outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Standardized Anesthetic Protocol for Le Fort Fracture Surgery?

Research shows that improvements in pediatric anesthesia outcomes have been achieved through advances in safety science, professional standardization, and subspecialty care, which suggests that a standardized anesthetic protocol could enhance safety and outcomes in surgeries like Le Fort fracture surgery. ^{1 2 3 4 5}

What safety data exists for the standardized anesthesia protocol in Le Fort fracture surgery?

The safety data for standardized anesthesia protocols, including those used in pediatric settings, emphasize the importance of personal and institutional competence, maintaining physiological homeostasis, and preventing complications. Studies highlight the need for careful preoperative assessment and planning to minimize risks. For instance, a study on general anesthesia in pediatric orthopedic surgery reported no major complications and a 13.3% incidence of minor complications, all of which resolved without sequelae. The Safetots initiative underscores the importance of quality anesthesia management over the choice of anesthetic drugs. Overall, the data suggest that with proper management and experienced anesthetists, standardized anesthesia protocols can be safe and effective. ^{2 4 6 7 8}

Is the standardized anesthesia protocol safe for use in humans?

Research shows that with careful planning and management, anesthesia protocols, especially in children, are generally safe. Key factors include identifying risks before surgery, preventing complications like pain and nausea, and having a competent team to ensure safety during and after surgery. ^{2 4 6 8 9}

Is the treatment called Standardized Anesthetic Course promising for Le Fort fracture surgery?

The treatment seems promising because it offers a structured approach to anesthesia, which can help manage pain effectively and reduce the need for strong painkillers. It also aims to make the surgery process smoother and safer, especially for children, by addressing common concerns like anxiety and respiratory issues. ^{10 11 12 13 14}

How is the Standardized Anesthetic Protocol for Le Fort Fracture Surgery different from other treatments?

The Standardized Anesthetic Protocol for Le Fort Fracture Surgery is unique because it offers a consistent approach to anesthesia, potentially reducing complications and costs associated with pediatric anesthesia, as seen in other studies where anesthesia-free techniques were explored for similar fractures. ^{10 11 12 13 14}

Research Team

Robin Yang, MD, DDS

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for young patients aged 14 or older who are scheduled to undergo Le Fort osteotomy at Johns Hopkins Hospital. It's not open to those who can't follow the standardized anesthetic protocol that will be used in the study.

Inclusion Criteria

I am scheduled for a Le Fort osteotomy at Johns Hopkins Hospital.

I am 14 years old or older.

Exclusion Criteria

I cannot have certain types of anesthesia due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Preoperative considerations and administration of premedications such as acetaminophen, scopolamine, and midazolam

1 day

1 visit (in-person)

Surgery and Immediate Postoperative Care

Standard induction with anesthetics and surgical procedures including nasotracheal intubation and administration of various medications

1 day

1 visit (in-person)

Postoperative Monitoring

Monitoring of postoperative pain, critical care utilization, and length of stay

2-7 days, up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Standardized Anesthetic Course

Trial Overview The study is testing a specific, uniform approach to anesthesia—from premedication to induction—in pediatric patients having Le Fort surgeries. The goal is to see if this method reduces post-surgery pain and hospital stay.

Participant Groups

Group I: Standardized Protocol Experimental Treatment 1 Intervention

Preop considerations 1. Ensure CBC, PT, PTT, type and cross are available, if not obtain with preop IV access Premed 1. Acetaminophen PO 15mg/kg 2. Scopolamine patch as indicated 3. Midazolam as indicated PO or IV Induction 1. Standard induction with lidocaine (1.5 mg/kg), propofol (1-3 mg/kg), and rocuronium (0.6mg/kg) 2. Fentanyl 100 mcg bolus 3. Dexmedetomidine 0.3 mcg/kg bolus 4. Nasotracheal intubation (NTI) - surgical team will suture to nasal septum 5. Place an additional PIV, ideally large gauge for volume resuscitation (18g or 16g) 6. Dexamethasone 4-8mg q4-6 hours per surgical request 7. Tranexamic acid 30mg/kg bolus (over 15 minutes) 8. Ancef 30 mg/kg bolus Monitors /Access 1. Standard ASA monitors 2. Avoid placing nasal or oral temperature probe as this interferes with surgical exposure 3. PIV x 2 is sufficient, have at least one large gauge PIV for volume resuscitation 4. Arterial catheter not necessary but place as needed, especially if patient is medically compl

Standardized Anesthetic Course is already approved in United States for the following indications:

Approved in United States as Standardized Anesthetic Course for:

• Anesthesia for pediatric LeFort surgeries

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Advancements in safety science across various areas, including equipment and drug safety, have led to improved outcomes in pediatric anesthesia.

Despite these improvements, there is a need for universal outcome measures and collaborative efforts across multiple disciplines and institutions to further enhance anesthesia safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of pediatric anesthesia. Hoffman, GM.[2019]

In a study of 270 pediatric surgical patients, intraoperative complications occurred in 5.1% of cases, while postoperative complications were noted in 9.25%, indicating that while complications are relatively low, they are still a significant concern in pediatric anesthesia.

Preterm infants and those under 12 months had the highest rates of complications, particularly respiratory issues, highlighting the need for careful monitoring and management in this vulnerable group to minimize anesthesia-related risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthesia-related complications in children. Edomwonyi, NP., Ekwere, IT., Egbekun, R., et al.[2014]

Since the 1950s, there have been significant improvements in the safety of pediatric anesthesia, leading to almost no reported mortality in children undergoing general anesthesia.

Most data on pediatric anesthesia outcomes come from specialized centers, highlighting a gap in quality care for children receiving anesthesia outside of these institutions; the study proposes creating universal outcome standards to address these disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond mortality: definitions and benchmarks of outcome standards in paediatric anaesthesiology. Olbrecht, VA., Engelhardt, T., Tobias, JD.[2023]

Safe and high-quality pediatric anesthesia relies on personal and institutional competence, maintaining physiological stability, and effective communication with parents, emphasizing the importance of training within standardized curricula.

The Safetots.org initiative highlights that preventing complications and ensuring quality anesthesia management are more crucial for positive outcomes than the specific anesthetic drugs used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical and societal implications of the potential anesthesia-induced neurotoxicity: The safetots perspective. Becke-Jakob, K., Disma, N., Hansen, TG.[2023]

The pediatric anesthesia research community is actively working on identifying standardized and validated outcomes to improve clinical care and research quality, focusing on areas like anesthesia, perioperative medicine, pain, and sedation.

Using the COMET initiative's standardized methodology, researchers aim to ensure that clinical outcomes are well-defined and consistent across trials, which is essential for accurately measuring health improvements and quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes in pediatric anesthesia: towards a universal language. Marchesini, V., Disma, N.[2023]

ENT surgeries are the most common procedures in children, and effective anesthetic management is crucial for ensuring a safe and comfortable experience, especially for those under 3 years old who are at higher risk for respiratory complications.

Preventing postoperative issues like pain and nausea (PONV) is essential, and having clear interdisciplinary guidelines can significantly enhance patient safety and outcomes in pediatric ENT surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pediatric anesthesia in ear nose throat (ENT) surgery]. Becke, K.[2014]

In a study of 836 pediatric patients undergoing general anesthesia at the Rizzoli Orthopaedic Institute, no major complications were reported, indicating a high level of safety for this anesthesia method in children.

Minor complications occurred in 13.3% of cases, but all resolved without lasting effects, suggesting that general anesthesia can be safely administered in a pediatric setting when managed properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[General anaesthesia for orthopaedic pediatric surgery]. Lari, S., Cipressi, M., Colì, A., et al.[2006]

Optimal anesthetic management in children undergoing ORL (otorhinolaryngology) procedures is crucial for ensuring a safe and uncomplicated perioperative experience, especially for those under 3 years old who are at higher risk for respiratory complications.

Preventing postoperative complications like pain and nausea (PONV) requires effective strategies, and interdisciplinary teamwork can significantly enhance patient safety and outcomes in pediatric surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthesia for ORL surgery in children. Becke, K.[2020]

In a study of 54 pediatric patients with angulated wrist and forearm fractures, closed reductions performed without anesthesia achieved satisfactory results, with 98% of patients having ≤10 degrees of residual angulation.

Caregiver satisfaction was high, with 98% of caregivers stating they would choose the anesthesia-free technique again, and only 9% of patients requiring pain medication, highlighting the effectiveness and safety of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"You're O.K. Anesthesia": Closed Reduction of Displaced Pediatric Forearm and Wrist Fractures in the Office Without Anesthesia. Livingstone, J., Opanova, M., Beaman, A., et al.[2022]

Anesthetic management in pediatric orthopedic patients requires special attention due to factors like increased preoperative anxiety and the potential for postoperative behavioral issues, which can affect pain management.

Recent studies confirm the safety of using regional anesthesia in children, which is beneficial for postoperative pain control and helps reduce the need for opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Anesthesia Concerns and Management for Orthopedic Procedures. Wu, JP.[2020]

In a study of 43 male patients with panfacial fractures, submental intubation was found to be the most reliable airway management technique, used in 86.1% of cases, highlighting its effectiveness during surgical treatment.

The 'bottom-up' and 'outside-in' approaches were the predominant methods for sequencing the repair of panfacial fractures, indicating a preference for these techniques in managing complex facial injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with Airway Management and Sequencing of Repair of Panfacial Fractures: A Single Tertiary Healthcare Appraisal in Najran, Kingdom of Saudi Arabia - A Retrospective Study. Daniels, JS., Albakry, I., Braimah, RO., et al.[2022]

A study involving 119 children aged 2 to 16 years showed that balanced spinal epidural anesthesia provides effective intraoperative and early postoperative pain relief during orthopedic surgeries on the lower extremities.

The method involved sequential punctures in the subarachnoid and epidural spaces, and it was found to be more effective than conventional general anesthesia, which was used in a control group of 60 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Balanced spinal-epidural anesthesia in pediatric orthopedics]. Abramov, AD., Lekmanov, AU., Popov, VV., et al.[2007]

A five-phase protocol for airway management was developed specifically for surgical patients with burns to the head and neck, addressing challenges like limited mouth opening and neck mobility.

The use of fiberoptic light and scope systems in this protocol allows for safe and efficient placement of the endotracheal tube before anesthesia, significantly reducing risks for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the difficult airway in patients with burns of the head and neck. Larson, SM., Parks, DH.[2022]

References

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

Outcomes of pediatric anesthesia. [2019]

2. Lebanon pubmed.ncbi.nlm.nih.gov

Anesthesia-related complications in children. [2014]

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

Beyond mortality: definitions and benchmarks of outcome standards in paediatric anaesthesiology. [2023]

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

Practical and societal implications of the potential anesthesia-induced neurotoxicity: The safetots perspective. [2023]

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

Outcomes in pediatric anesthesia: towards a universal language. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

[Pediatric anesthesia in ear nose throat (ENT) surgery]. [2014]

7. Italy pubmed.ncbi.nlm.nih.gov

[General anaesthesia for orthopaedic pediatric surgery]. [2006]

8. Germany pubmed.ncbi.nlm.nih.gov

Anesthesia for ORL surgery in children. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A Time-Out Checklist for Pediatric Regional Anesthetics. [2019]

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

"You're O.K. Anesthesia": Closed Reduction of Displaced Pediatric Forearm and Wrist Fractures in the Office Without Anesthesia. [2022]

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

Pediatric Anesthesia Concerns and Management for Orthopedic Procedures. [2020]

12. India pubmed.ncbi.nlm.nih.gov

Experience with Airway Management and Sequencing of Repair of Panfacial Fractures: A Single Tertiary Healthcare Appraisal in Najran, Kingdom of Saudi Arabia - A Retrospective Study. [2022]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Balanced spinal-epidural anesthesia in pediatric orthopedics]. [2007]

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

Managing the difficult airway in patients with burns of the head and neck. [2022]