What is this study studying for patients undergoing Le Fort osteotomy?

This study is evaluating a new standardized anesthesia protocol for patients undergoing Le Fort osteotomy. It aims to improve surgical outcomes by reducing postoperative pain, hospital stay, and long-term complications. The research is sponsored by Johns Hopkins University and compares this new approach to previous standard care.

Who may be eligible for this Le Fort osteotomy clinical trial?

Patients aged 14 years or older who are scheduled for Le Fort osteotomy at Johns Hopkins Hospital may be eligible. It is open to all genders but excludes those with contraindications to the study's anesthetic protocol. Please review eligibility criteria for more details.

Is there any cost to participate in this Le Fort osteotomy clinical trial?

Study-related care, including the anesthesia protocol and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 14Years +

All Genders

Healthy Volunteers

ID05260320

Evaluating a Standardized Anesthetic Protocol for Pediatric Patients Undergoing Le Fort Osteotomy at Johns Hopkins Hospital to Improve Recovery and Reduce Pain

Led by Johns Hopkins University · Updated on 2026-05-20

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

The trial investigates a standardized anesthetic protocol for pediatric patients undergoing Le Fort osteotomy at Johns Hopkins Hospital. It compares a prospective group receiving the new anesthesia approach to a historical group treated with standard care. The goal is to improve surgical outcomes by reducing postoperative pain, inpatient stay, and long-term complications in these patients. Participants in the experimental group will receive a detailed anesthesia plan covering from premedication through induction. This includes medications like acetaminophen, midazolam, fentanyl, and dexmedetomidine, as well as specific procedures such as nasotracheal intubation and volume resuscitation. The protocol also outlines monitoring standards and medication dosages tailored to support surgical needs. During the study, participants will be observed from hospital admission on the day of surgery until discharge, expected between 2 to 7 days but possibly up to 30 days. Researchers will assess postoperative pain, length of hospital stay, and critical care use. The study includes various clinical evaluations to measure these outcomes and monitor patient recovery and safety throughout the hospital stay.

CONDITIONS

Brief Title

Anesthetic Optimization in Pediatric LeFort Surgeries

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Standardized Protocol	Historical Standard Care	Current Standard Care
What it is	A structured anesthetic pathway covering from premedication through induction, applied to prospective cohort undergoing Le Fort osteotomy	Retrospective cohort treated under routine anesthetic practices prior to protocol implementation	Modern pediatric perioperative anesthetic care typically uses multimodal pain control, airway preparation, and opioid-sparing strategies
Role in trial	Investigational protocol evaluated prospectively in this study	Retrospective comparator representing prior routine anesthetic practice	Represents typical contemporary perioperative anesthetic approach outside the trial
Primary use	To minimize postoperative pain, hospital stay, and critical care use after Le Fort surgery	To manage anesthesia according to routine pre-protocol clinical practice	To safely support surgical anesthesia with pain management, airway care, and recovery protocols
How it is given or performed	Delivered according to a predefined protocol outlining premedication drugs and induction sequence	Provided under clinician discretion using routine anesthetic methods	Involves multimodal analgesic techniques, airway readiness planning, and controlled opioid use
Evidence status	Effectiveness in reducing postoperative pain, length of stay and critical care use is under investigation	Evidence based only on retrospective standard practice without formal evaluation	Supported by general perioperative care guidelines favoring multimodal analgesia and airway planning
Important risks	Risk of airway complications and bleeding typical of Le Fort osteotomy anesthesia	Same surgical anesthesia risks inherent under routine management	Modern airway management and anesthetic approaches aim to mitigate these anesthesia-related risks
Important limitations	Outcomes compared to historical cohort rather than randomized control	Retrospective data may not account for all confounding factors	Context drawn from general practice rather than exact Le Fort-specific protocol
Patient impact	Potential to reduce postoperative pain and hospital stay, but not yet proven	Baseline impact unknown due to lack of formal evaluation	Multimodal approaches have been shown to improve recovery and comfort in pediatric surgical patients

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 14Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Undergoing Le Fort osteotomy at Johns Hopkins Hospital
Age 14 years or older

You will not qualify if you...

Contraindications to standardized anesthetic protocol (intervention arm)

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment

Treatment

Duration - From hospital admission on day of surgery to discharge, expected to last 2 to 7 days but may be up to 30 days

Participants undergo a standardized anesthetic protocol during their LeFort osteotomy surgery including premedication, induction, and intraoperative management.

Hospital admission and continuous inpatient monitoring until discharge

Follow-up

Duration - Up to 30 days post-surgery if needed

Participants are monitored for postoperative pain, length of stay, and critical care utilization after surgery until discharge.

Approximately daily inpatient assessments until discharge