Anesthetic Optimization in Pediatric LeFort Surgeries

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05260320
Status
Recruiting
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Conditions

  • Le Fort
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Standardized Anesthetic Course from Premedication to Induction — OTHER
    See information in intervention group description

Study Details

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.

Key Dates

Start date
May 2, 2025
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Robin Yang, MD, DDS
[email protected]
443-997-9466

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By research site
Johns Hopkins Hospital· Baltimore, MD

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