Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05260320

Anesthetic Optimization in Pediatric LeFort Surgeries

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Le Fort Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Robin Yang, MD, DDS

CONTACT

[email protected]

443-997-9466

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications to standardized anesthetic protocol (intervention arm)

Treatment and study plan

Standardized Anesthetic Course from Premedication to Induction

Other

See information in intervention group description

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Robin Yang, MD, DDS

CONTACT

[email protected]

443-997-9466

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2022
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.