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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized Protocol | Experimental | Preop considerations 1. Ensure CBC, PT, PTT, type and cross are available, if not obtain with preop IV access Premed
Induction
Monitors /Access
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Anesthetic Course from Premedication to Induction | Other | See information in intervention group description |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robin Yang, MD, DDS | Contact | 443-997-9466 | ryang14@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robin Yang, MD, DDS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13376109 | Background | SADOVE MS. Anesthetic management for maxillofacial surgery. Ill Med J. 1956 Nov;110(5):227-31. No abstract available. | |
| 34046286 | Background | 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. |
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IPD will be shared with those conducting research data collection and analysis, and IPD that underlie results in a publication will be published.
Data will become available to the study team upon collection and will be deleted after publication
IPD access will be granted to those researchers making significant contributions to data collection or analysis, at the discretion of the principal investigator
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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All consented patients will receive the intervention.
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Utilization, and, where appropriate, length of use of the following: ICU, ventilatory support, intubation, blood products
| From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days |
| 31073483 | Background | 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. |
| 31645264 | Background | 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. |
| 32346234 | Background | 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. |
| 14704568 | Background | 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. |
| 26303951 | Background | 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. |
| 29446987 | Background | 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. |
| 3936793 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |