Clinical trial NCT05260320: Anesthetic Optimization in Pediatric LeFort Surgeries
Official title: Anesthetic Optimization in Pediatric LeFort Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Le Fort
Pain, Postoperative
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All consented patients will receive the intervention.
Primary purpose: PREVENTION

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.

Detailed description: 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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Contraindications to standardized anesthetic protocol (intervention arm)

Primary outcomes:
measure: Postoperative pain
timeFrame: 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:
measure: Length of stay
timeFrame: From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
measure: Critical care utilization
timeFrame: From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robin Yang, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: SADOVE MS. Anesthetic management for maxillofacial surgery. Ill Med J. 1956 Nov;110(5):227-31. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.