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Anesthetic Optimization in Pediatric LeFort Surgeries

Anesthetic Optimization in Pediatric LeFort Surgeries

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05260320
Enrollment
50
Registered
2022-03-02
Start date
2025-05-02
Completion date
2027-07-01
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Le Fort, Pain, Postoperative

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.

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.

Interventions

OTHERStandardized Anesthetic Course from Premedication to Induction

See information in intervention group description

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

All consented patients will receive the intervention.

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Contraindications to standardized anesthetic protocol (intervention arm)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painFrom hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 daysThe degree (as ranked on a scale from 1-10) and duration of postoperative pain, including necessity of postoperative analgesia

Secondary

MeasureTime frameDescription
Length of stayFrom hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 daysLength of inpatient stay (in days)
Critical care utilizationFrom hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 daysUtilization, and, where appropriate, length of use of the following: ICU, ventilatory support, intubation, blood products

Countries

United States

Contacts

CONTACTRobin Yang, MD, DDS
ryang14@jhmi.edu443-997-9466
PRINCIPAL_INVESTIGATORRobin Yang, MD, DDS

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026