Anesthetic Optimization in Pediatric LeFort Surgeries

May 18, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to standardized anesthetic protocol (intervention arm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Standardized Anesthetic Course from Premedication to Induction
See information in intervention group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The degree (as ranked on a scale from 1-10) and duration of postoperative pain, including necessity of postoperative analgesia
From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
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
Length of inpatient stay (in days)
From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
Critical care utilization
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
Utilization, and, where appropriate, length of use of the following: ICU, ventilatory support, intubation, blood products
From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Robin Yang, MD, DDS, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00316335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared with those conducting research data collection and analysis, and IPD that underlie results in a publication will be published.

IPD Sharing Time Frame

Data will become available to the study team upon collection and will be deleted after publication

IPD Sharing Access Criteria

IPD access will be granted to those researchers making significant contributions to data collection or analysis, at the discretion of the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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