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Standardized Anesthesia Protocol for Le Fort Fracture Surgery
N/A
Recruiting
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing Le Fort osteotomy at Johns Hopkins Hospital
Age >= 14 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
Awards & highlights
Study Summary
This trial will test a new anesthetic protocol for kids getting a LeFort osteotomy at Johns Hopkins. The goal is to reduce post-op pain, shorten hospital stays, and improve long-term outcomes.
Who is the study for?
This trial is for young patients aged 14 or older who are scheduled to undergo Le Fort osteotomy at Johns Hopkins Hospital. It's not open to those who can't follow the standardized anesthetic protocol that will be used in the study.Check my eligibility
What is being tested?
The study is testing a specific, uniform approach to anesthesia—from premedication to induction—in pediatric patients having Le Fort surgeries. The goal is to see if this method reduces post-surgery pain and hospital stay.See study design
What are the potential side effects?
While the trial description does not list specific side effects, general risks of anesthesia may include nausea, vomiting, sore throat, drowsiness, and in rare cases more serious complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a Le Fort osteotomy at Johns Hopkins Hospital.
Select...
I am 14 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative pain
Secondary outcome measures
Critical care utilization
Length of stay
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standardized ProtocolExperimental Treatment1 Intervention
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
Group II: Provider Choice ProtocolActive Control1 Intervention
Patients will be managed with provider-specific protocols, which may vary.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,447 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a Le Fort osteotomy at Johns Hopkins Hospital.I cannot have certain types of anesthesia due to health reasons.I am 14 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Standardized Protocol
- Group 2: Provider Choice Protocol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are signing up for this research project?
"Confirmed. The clinicaltrials.gov website indicates that this trial is actively recruiting; the original post date was October 18th 2022 and it has been updated as recently as November 22nd 2022. 50 patients are required for participation at a single medical centre."
Answered by AI
Is there an age cutoff for enlistment in this experiment?
"According to the stated inclusion criteria, eligible participants must range in age from 14 years old up until 18."
Answered by AI
To what extent are individuals eligible to participate in this trial?
"Eligibility criteria for this trial involves postoperative pain in minors aged 14-18. This clinical study seeks to recruit a total of fifty participants."
Answered by AI
Is recruitment still open for this medical experiment?
"Indeed, the information hosted on clinicaltrials.gov confirms that this study is actively seeking participants. The trial was first advertised on October 18th 2022 and has been updated as recently as November 22nd 2022. Approximately 50 patients need to be sourced from one location for inclusion in the research."
Answered by AI
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