Anesthetic Optimization in Pediatric LeFort Surgeries

Pain, Postoperative Clinical Trial

Official title:

Anesthetic Optimization in Pediatric LeFort Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260320
• Other study ID #: IRB00316335
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: July 2025

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Robin Yang, MD, DDS
• Phone: 443-997-9466
• Email: ryang14[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Undergoing Le Fort osteotomy at Johns Hopkins Hospital

• Age >= 14 years

Exclusion Criteria:

• Contraindications to standardized anesthetic protocol (intervention arm)

Related Conditions & MeSH terms

• Le Fort
• Pain, Postoperative

Intervention

Other:
• Standardized Anesthetic Course from Premedication to Induction
See information in intervention group description

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

SADOVE MS. Anesthetic management for maxillofacial surgery. Ill Med J. 1956 Nov;110(5):227-31. No abstract available. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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