Anesthetic Optimization in Pediatric LeFort Surgeries

NCT05260320 | Recruiting

• 1 other identifier: IRB00316335
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  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 Outcomes (2)

• Length of stay

  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

  From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days

Study Arms (1)

Standardized Protocol

EXPERIMENTAL

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

Interventions

Standardized Anesthetic Course from Premedication to Induction OTHER

See information in intervention group description

Standardized Protocol

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindications to standardized anesthetic protocol (intervention arm)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (9)

• SADOVE MS. Anesthetic management for maxillofacial surgery. Ill Med J. 1956 Nov;110(5):227-31. No abstract available.

  PMID: 13376109 BACKGROUND

• Lucin Yagual TA, Vivanco Murillo SM, Espinoza Daquilema NV, Mariscal Garcia RS, Dick Paredes DF. Smooth Extubation Techniques in Pediatric Patients After LeFort I Osteotomy. Cureus. 2021 Apr 24;13(4):e14659. doi: 10.7759/cureus.14659.

  PMID: 34046286 BACKGROUND

• Krishna SG, Bryant JF, Tobias JD. Management of the Difficult Airway in the Pediatric Patient. J Pediatr Intensive Care. 2018 Sep;7(3):115-125. doi: 10.1055/s-0038-1624576. Epub 2018 Jan 28.

  PMID: 31073483 BACKGROUND

• Gleizal A, Di Rocco F, Chauvel-Picard J. Indications of Lefort osteotomies for facial deformities induced by craniosynostosis. Neurochirurgie. 2019 Nov;65(5):279-285. doi: 10.1016/j.neuchi.2019.10.002. Epub 2019 Oct 16. No abstract available.

  PMID: 31645264 BACKGROUND

• Tewari A, Singh G, Mishra M, Gaur A, Mallan D. Comparative Evaluation of Hypotensive and Normotensive Anesthesia on LeFort I Osteotomies: A Randomized, Double-Blind, Prospective Clinical Study. J Maxillofac Oral Surg. 2020 Jun;19(2):240-245. doi: 10.1007/s12663-019-01325-7. Epub 2020 Jan 17.

  PMID: 32346234 BACKGROUND

• Wong GB, Nargozian C, Padwa BL. Anesthetic concerns of external maxillary distraction osteogenesis. J Craniofac Surg. 2004 Jan;15(1):78-81. doi: 10.1097/00001665-200401000-00022.

  PMID: 14704568 BACKGROUND

• Posnick JC, Choi E, Chavda A. Operative Time, Airway Management, Need for Blood Transfusions, and In-Hospital Stay for Bimaxillary, Intranasal, and Osseous Genioplasty Surgery: Current Clinical Practices. J Oral Maxillofac Surg. 2016 Mar;74(3):590-600. doi: 10.1016/j.joms.2015.07.026. Epub 2015 Aug 5.

  PMID: 26303951 BACKGROUND

• Lopez MM, Zech D, Linton JL, Blackwell SJ. Dexmedetomidine Decreases Postoperative Pain and Narcotic Use in Children Undergoing Alveolar Bone Graft Surgery. Cleft Palate Craniofac J. 2018 May;55(5):688-691. doi: 10.1177/1055665618754949. Epub 2018 Feb 15.

  PMID: 29446987 BACKGROUND

• Precious DS, McFadden LR, Fitch SJ. Orthognathic surgery for children. Analysis of 88 consecutive cases. Int J Oral Surg. 1985 Dec;14(6):466-71. doi: 10.1016/s0300-9785(85)80051-x.

  PMID: 3936793 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Robin Yang, MD, DDS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Yang, MD, DDS

CONTACT

443-997-9466; ryang14@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All consented patients will receive the intervention.

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 2, 2022
• Study Start: May 2, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available to the study team upon collection and will be deleted after publication
• 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

Locations

US (1)