Anesthetic management for maxillofacial surgery.
M S SADOVE
https://pubmed.ncbi.nlm.nih.gov/13376109Actively Recruiting
Phase Not Applicable
Age: 14Years +
All Genders
Healthy Volunteers
ID05260320
Anesthetic Optimization in Pediatric LeFort Surgeries
Led by Johns Hopkins University · Updated on 2026-05-20
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
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
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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
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Research Team
R
Robin Yang, MD, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
Smooth Extubation Techniques in Pediatric Patients After LeFort I Osteotomy.
Teresa Anabel Lucín Yagual, Sócrates Marcelo Vivanco Murillo, Nataly Vanessa Espinoza Daquilema...
https://pubmed.ncbi.nlm.nih.gov/34046286Management of the Difficult Airway in the Pediatric Patient.
Senthil G Krishna, Jason F Bryant, Joseph D Tobias
https://pubmed.ncbi.nlm.nih.gov/31073483Indications of Lefort osteotomies for facial deformities induced by craniosynostosis.
A Gleizal, F Di Rocco, J Chauvel-Picard
https://pubmed.ncbi.nlm.nih.gov/31645264Comparative Evaluation of Hypotensive and Normotensive Anesthesia on LeFort I Osteotomies: A Randomized, Double-Blind, Prospective Clinical Study.
Abhivyakti Tewari, Gaurav Singh, Madan Mishra...
https://pubmed.ncbi.nlm.nih.gov/32346234Anesthetic concerns of external maxillary distraction osteogenesis.
Granger B Wong, Charles Nargozian, Bonnie L Padwa
https://pubmed.ncbi.nlm.nih.gov/14704568Operative Time, Airway Management, Need for Blood Transfusions, and In-Hospital Stay for Bimaxillary, Intranasal, and Osseous Genioplasty Surgery: Current Clinical Practices.
Jeffrey C Posnick, Elbert Choi, Anish Chavda
https://pubmed.ncbi.nlm.nih.gov/26303951Dexmedetomidine Decreases Postoperative Pain and Narcotic Use in Children Undergoing Alveolar Bone Graft Surgery.
Mariela M Lopez, Derrick Zech, Judith L Linton...
https://pubmed.ncbi.nlm.nih.gov/29446987Orthognathic surgery for children. Analysis of 88 consecutive cases.
D S Precious, L R McFadden, S J Fitch
https://pubmed.ncbi.nlm.nih.gov/3936793