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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new anesthetic protocol for children undergoing Le Fort osteotomy, a type of jaw surgery, at Johns Hopkins Hospital. The goal is to determine if this approach can reduce post-surgery pain and shorten hospital stays compared to usual care. Participants will either receive this new anesthetic or be compared to past patients who underwent the standard procedure. Ideal participants are those already scheduled for Le Fort osteotomy at this hospital and are 14 years or older. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical recovery for future 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 prior data suggests that this standardized anesthesia protocol is safe for pediatric patients?

Research has shown that the standard anesthesia method for children undergoing LeFort surgery has been tested in 270 cases. Complications occurred in 5.1% of these cases during surgery and in 9.25% after surgery. These findings suggest that the method is generally well-tolerated, though some risks exist, as with any medical procedure. It is important to understand that such complications are not unusual in surgeries, and the standard method aims to reduce these risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a standardized anesthesia protocol specifically for Le Fort fracture surgeries. Unlike the varied, more individualized approaches used currently, this protocol aims to streamline anesthesia delivery, potentially improving patient outcomes and surgical efficiency. By incorporating a specific sequence of medications like lidocaine, propofol, and dexmedetomidine, along with precise dosing and timing, the protocol could offer a more predictable and safer experience for patients undergoing these complex facial surgeries.

What evidence suggests that this standardized anesthesia protocol is effective for Le Fort fracture surgery?

Research has shown that using a standard method for anesthesia in children with Le Fort fractures can lead to better results. Participants in this trial will receive a standardized anesthesia protocol. In a study of 270 children undergoing surgery, only 5.1% experienced problems during the operation, and 9.25% had issues afterward. These findings suggest that a consistent approach can reduce complications during and after surgery. Reviews also highlight the importance of standard practices for successful outcomes. Overall, the evidence indicates that this protocol makes surgery more controlled and safer. ^{1 2 3 4 5}

Who Is on the Research Team?

Robin Yang, MD, DDS

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. withpower.com withpower.com/trial/phase-le-fort-5-2022-b26fa

Standardized Anesthesia Protocol for Le Fort Fracture ... In a study of 270 pediatric surgical patients, intraoperative complications occurred in 5.1% of cases, while postoperative complications were noted in 9.25%, ...

2. joma.amegroups.org joma.amegroups.org/article/view/6750/html

Review of anesthesia in maxillofacial trauma - Pearl This literature review endeavors to provide a comprehensive account of the diverse array of anesthesia strategies employed in the management of maxillofacial ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2768276524007910

Regional and Local Anesthesia in Pediatric Orthopaedic ... This content can potentially serve as a practical guide for optimizing the perioperative anesthesia plan for different pediatric orthopaedic procedures.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05260320

Anesthetic Optimization in Pediatric LeFort Surgeries This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10890671/

State of the Art in Pediatric Anesthesia: A Narrative Review ... The results of this paper support the need for standardized protocols and guidelines and encourage the centralization of practices to enhance clinical efficacy.