Anesthetic Optimization in Pediatric LeFort Surgeries

Johns Hopkins University

Status: Enrolling

Conditions: Pain, Postoperative; Le Fort

Treatments: Other: Standardized Anesthetic Course from Premedication to Induction

Study type: Interventional

Funder types: Other

Identifiers

NCT05260320

IRB00316335

Details and patient eligibility

About

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.

Full description

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 hypothesize that implementation of this standardized protocol will show improved surgical outcomes among these patients as compared to current (discretionary) treatment. This study aims to optimize the anesthetic management of these patients in order to minimize postoperative pain management, inpatient stay, and long-term morbidity and mortality in these complex patients.

Enrollment: 50 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Undergoing Le Fort osteotomy at Johns Hopkins Hospital
• Age >= 14 years

Exclusion criteria

• Contraindications to standardized anesthetic protocol (intervention arm)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Standardized Protocol

Experimental group

Description:

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

Treatment:

Other: Standardized Anesthetic Course from Premedication to Induction