Anesthetic Optimization in Pediatric LeFort Surgeries

Study Overview
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Brief Summary
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This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital via a randomized controlled trial. 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
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This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital via a randomized controlled trial. 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.

Official Title
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Anesthetic Optimization in Pediatric LeFort Surgeries

Conditions
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Le Fort, Pain, Postoperative

Intervention / Treatment
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* Other: Standardized Anesthetic Course from Premedication to Induction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing Le Fort osteotomy at Johns Hopkins Hospital Age >= 14 years Exclusion Criteria: Contraindications to standardized anesthetic protocol (intervention arm)

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to one of two study arms: intervention (standardized protocol) or control (no standardized protocol)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized Protocol<br>Premed Acetaminophen PO 15mg/kg Scopolamine patch + PO/IV Midazolam as needed Induction Lidocaine (1.5 mg/kg), propofol (1-3 mg/kg), and rocuronium (0.6mg/kg) Fentanyl 100 mcg bolus Dexmedetomidine 0.3 mcg/kg bolus Nasotracheal intubation (NTI) Dexamethasone 4-8mg q4-6 hours Tranexamic acid 30mg/kg bolus Ancef 30 mg/kg bolus Room Bolus line 4 Channel/pump infusion line w/: Maintenance IVFs/Carrier, Dexmedetomidine, TXA, Precedex or Phenylephrine Maintenance Sevo/isoflurane at 0.5-0.7 MAC with rocuronium boluses as needed Dexmedetomidine 0.3- 0.5 mcg/kg/hour Fentanyl 50 mcg boluses TXA 15 mg/kg/hr Phenylephrine 0.2-1 mcg/kg/min as needed Emergence Stop dexmedetomidine before emergence Re-dose acetaminophen 15 mg/kg IV Toradol 0.5 mg/kg Zofran 0.15 mg/kg Reverse with sugammadex OGT placement, extubate awake | Other: Standardized Anesthetic Course from Premedication to Induction<br>* See information in intervention group description<br>|
| No Intervention: Provider Choice Protocol<br>Patients will be managed with provider-specific protocols, which may vary. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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