Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery

NCT03190642 | Completed Phase 4

• 1 other identifier: OMFSTEROIDS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use of one gram of methylprednisolone administered intravenously prior to orthognathic surgery. This is largely based on the work of Habal. The administration of one gram of methylprednisolone can be concerning for the anesthesiologist since this is an unusually large dose of steroid in comparison to use in other surgical specialties. As with most medications, the chances of steroid-related complications increase with increasing doses of steroids. The researchers are proposing a prospective, double-blind randomized control trial to determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively instead of one gram of methylprednisolone.

Conditions

Post-operative Edema; Steroid Use

Keywords

Orthognathic Surgery; Swelling

Outcome Measures

Primary Outcomes (1)

• Post-operative edema

  Measurement of post-operative edema using 3D facial scanner

  Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, whichever comes first

Secondary Outcomes (6)

• Patient perceived swelling

  Post-operative day 2

• Post-operative pain

  Post-operative day 2

• Post-operative sleep

  Post-operative day 2

• Post-operative nausea

  Post-operative day 2

• Length of hospital stay

  Until discharge from hospital or post-operative day 100, which ever comes first

Study Arms (2)

1000mg methylprednisolone group

ACTIVE COMPARATOR

Evaluating effects of 1000mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling.

Drug: Methylprednisolone

125mg methylprednisolone group

ACTIVE COMPARATOR

Evaluating effects of 125mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling.

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

Administration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery.

Also known as: Solumedrol

1000mg methylprednisolone group; 125mg methylprednisolone group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients age 14 and over undergoing orthognathic surgery at the Atlantic Centre of Oral and Maxillofacial Surgery in Halifax, Nova Scotia will be included in our study. The clinic is located in the Victoria General Hospital in Halifax, Nova Scotia. Orthognathic surgery includes any combination of Lefort 1, Bilateral Sagittal Split Osteotomy (BSSO) and functional genioplasty procedures.

You may not qualify if:

• Patients with pertinent medical history that precludes the use of high-dose steroids will be excluded from our study. This includes:
• Known hypersensitivity to steroids
• Type 1 diabetic patients who may have a severe elevation of blood sugars with steroid use.
• Systemic fungal infections
• Arrested tuberculosis
• Herpes simplex keratitis
• Acute psychoses
• Cushing's syndrome
• Peptic ulcer disease
• Pregnant patients and patients with current infections will be excluded Breast feeding mother

Sponsors & Collaborators

• Jean Charles Doucet: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

QE II Health Sciences Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (15)

• Guernsey LH, DeChamplain RW. Sequelae and complications of the intraoral sagittal osteotomy in the mandibular rami. Oral Surg Oral Med Oral Pathol. 1971 Aug;32(2):176-92. doi: 10.1016/0030-4220(71)90221-0. No abstract available.

  PMID: 5284103 BACKGROUND

• Dan AE, Thygesen TH, Pinholt EM. Corticosteroid administration in oral and orthognathic surgery: a systematic review of the literature and meta-analysis. J Oral Maxillofac Surg. 2010 Sep;68(9):2207-20. doi: 10.1016/j.joms.2010.04.019. Epub 2010 Jun 29.

  PMID: 20591548 BACKGROUND

• Habal MB, Powell RD. Experimental facial edema: treatment with methylprednisolone. J Surg Res. 1978 May;24(5):353-8. doi: 10.1016/0022-4804(78)90026-4. No abstract available.

  PMID: 651330 BACKGROUND

• Habal MB. Prevention of postoperative facial edema with steroids after facial surgery. Aesthetic Plast Surg. 1985;9(2):69-71. doi: 10.1007/BF01570331.

  PMID: 4025052 BACKGROUND

• Chegini S, Dhariwal DK. Review of evidence for the use of steroids in orthognathic surgery. Br J Oral Maxillofac Surg. 2012 Mar;50(2):97-101. doi: 10.1016/j.bjoms.2010.11.019. Epub 2011 Feb 12.

  PMID: 21316821 BACKGROUND

• Huaman ET, Juvet LM, Nastri A, Denman WT, Kaban LB, Dodson TB. Changing patterns of hospital length of stay after orthognathic surgery. J Oral Maxillofac Surg. 2008 Mar;66(3):492-7. doi: 10.1016/j.joms.2007.08.025.

  PMID: 18280382 BACKGROUND

• Poetker DM, Reh DD. A comprehensive review of the adverse effects of systemic corticosteroids. Otolaryngol Clin North Am. 2010 Aug;43(4):753-68. doi: 10.1016/j.otc.2010.04.003.

  PMID: 20599080 BACKGROUND

• Precious DS, Hoffman CD, Miller R. Steroid acne after orthognathic surgery. Oral Surg Oral Med Oral Pathol. 1992 Sep;74(3):279-81. doi: 10.1016/0030-4220(92)90058-x.

  PMID: 1407985 BACKGROUND

• Galen DM, Beck M, Buchbinder D. Steroid psychosis after orthognathic surgery: a case report. J Oral Maxillofac Surg. 1997 Mar;55(3):294-7. doi: 10.1016/s0278-2391(97)90546-2. No abstract available.

  PMID: 9054921 BACKGROUND

• Weber CR, Griffin JM. Evaluation of dexamethasone for reducing postoperative edema and inflammatory response after orthognathic surgery. J Oral Maxillofac Surg. 1994 Jan;52(1):35-9. doi: 10.1016/0278-2391(94)90010-8.

  PMID: 8263640 BACKGROUND

• Widar F, Kashani H, Alsen B, Dahlin C, Rasmusson L. The effects of steroids in preventing facial oedema, pain, and neurosensory disturbances after bilateral sagittal split osteotomy: a randomized controlled trial. Int J Oral Maxillofac Surg. 2015 Feb;44(2):252-8. doi: 10.1016/j.ijom.2014.08.002. Epub 2014 Oct 7.

  PMID: 25304755 BACKGROUND

• van der Meer WJ, Dijkstra PU, Visser A, Vissink A, Ren Y. Reliability and validity of measurements of facial swelling with a stereophotogrammetry optical three-dimensional scanner. Br J Oral Maxillofac Surg. 2014 Dec;52(10):922-7. doi: 10.1016/j.bjoms.2014.08.019. Epub 2014 Sep 15.

  PMID: 25219776 BACKGROUND

• Lubbers HT, Medinger L, Kruse A, Gratz KW, Matthews F. Precision and accuracy of the 3dMD photogrammetric system in craniomaxillofacial application. J Craniofac Surg. 2010 May;21(3):763-7. doi: 10.1097/SCS.0b013e3181d841f7.

  PMID: 20485043 BACKGROUND

• Esen E, Tasar F, Akhan O. Determination of the anti-inflammatory effects of methylprednisolone on the sequelae of third molar surgery. J Oral Maxillofac Surg. 1999 Oct;57(10):1201-6; discussion 1206-8. doi: 10.1016/s0278-2391(99)90486-x.

  PMID: 10513866 BACKGROUND

• Ichinose M, Sugiura H, Nagase H, Yamaguchi M, Inoue H, Sagara H, Tamaoki J, Tohda Y, Munakata M, Yamauchi K, Ohta K; Japanese Society of Allergology. Japanese guidelines for adult asthma 2017. Allergol Int. 2017 Apr;66(2):163-189. doi: 10.1016/j.alit.2016.12.005. Epub 2017 Feb 11.

  PMID: 28196638 BACKGROUND

MeSH Terms

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 19, 2017
• Study Start: January 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: December 31, 2019
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)