Anesthetic Optimization in Pediatric LeFort Surgeries
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Standardized Protocol Patients will have the following operative anesthetic course: Premed Acetaminophen PO 15mg/kg Scopolamine patch + PO/IV Midazolam as needed Induction Standard: lidocaine (1.5 mg/kg), propofol (1-3 mg/kg), rocuronium (0.6mg/kg) Sufentanil 1 mcg/kg bolus Nasotracheal intubation Dexamethasone 4-8mg q4-6 hours Tranexamic acid (TXA) 30mg/kg bolus Ancef 30 mg/kg bolus Room Bolus line 4 Channel/pump infusion line with: Maintenance IVFs/Carrier, Sufentantil, TXA, Precedex or Phenylephrine Maintenance Sevo/isoflurane at 0.5-0.7 MAC with rocuronium boluses as needed Sufenantil 0.3 mcg/kg/hr, titrate as needed TXA 15 mg/kg/hr Phenylephrine 0.2-1 mcg/kg/min as needed Emergence Stop sufentanil 1 hr before closing, start dexmedetomidine 0.5 mcg/kg/hr Re-dose acetaminophen 15 mg/kg IV Toradol 0.5 mg/kg Zofran 0.15 mg/kg Reverse with sugammadex OGT placement, extubate awake |
Other: Standardized Anesthetic Course from Premedication to Induction
See information in intervention group description
|
No Intervention: Provider Choice Protocol Patients will be managed with provider-specific protocols, which may vary. |
Outcome Measures
Primary Outcome Measures
- Postoperative pain [From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days]
The degree (as ranked on a scale from 1-10) and duration of postoperative pain, including necessity of postoperative analgesia
Secondary Outcome Measures
- Length of stay [From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days]
Length of inpatient stay (in days)
- Critical care utilization [From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days]
Utilization, and, where appropriate, length of use of the following: ICU, ventilatory support, intubation
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Undergoing Le Fort osteotomy at Johns Hopkins Hospital
-
Age >= 14 years
Exclusion Criteria:
- Contraindications to standardized anesthetic protocol (intervention arm)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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. Review.
- 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.
- Lucín Yagual TA, Vivanco Murillo SM, Espinoza Daquilema NV, Mariscal García 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.
- 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.
- 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.
- SADOVE MS. Anesthetic management for maxillofacial surgery. Ill Med J. 1956 Nov;110(5):227-31.
- 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.
- Wong GB, Nargozian C, Padwa BL. Anesthetic concerns of external maxillary distraction osteogenesis. J Craniofac Surg. 2004 Jan;15(1):78-81.
- IRB00316335