Recruiting

LeFort Osteotomy

Sponsor:

Johns Hopkins University

Code:

NCT05260320

Conditions

Le Fort

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Interventions

Standardized Anesthetic Course from Premedication to Induction

Study Details

Brief summary:

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.

Conditions

Le Fort

Pain, Postoperative

Study ID

NCT05260320

Start date

May 2, 2025

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to standardized anesthetic protocol (intervention arm)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Standardized Protocol

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

Interventions

Standardized Anesthetic Course from Premedication to Induction

See information in intervention group description

Primary outcome measure

  • Postoperative pain [ Time Frame: From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days ]

Central Contacts and Locations

Central contacts

Robin Yang, MD, DDS

443-997-9466ryang14@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Robin Yang, MD, DDS

443-997-9466ryang14@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-20.