Anesthetic Optimization in Pediatric LeFort Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Undergoing Le Fort osteotomy at Johns Hopkins Hospital
Age >= 14 years
Disqualifiers
Contraindications to standardized anesthetic protocol (intervention arm)
Trial design
Design model
Single group
Treatments tested in this trial
Standardized Anesthetic Course from Premedication to Induction
Other interventionSee information in intervention group description
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Standardized ProtocolExperimental treatment 1 intervention
Trial outcomes
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
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 daysSecondary outcomes
1
Length of stay
Length of inpatient stay (in days)
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 days2
Critical care utilization
Utilization, and, where appropriate, length of use of the following: ICU, ventilatory support, intubation, blood products
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 daysSponsors and contacts
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Source ClinicalTrials.gov