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Comparison of Submucosal Dexamethasone and Methylprednisolone in Postoperative Sequelae of Parasymphsis Fractures

ConditionsMandible FractureEdema FacePain ManagementCorticosteroid Injection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorNishtar Medical University

About this trial

The rationale of the current research is to address the limitation of existing knowledge as it is not clear which of the two drugs (Dexamethasone or Methylprednisolone) is more effective in reduction of postoperative sequelae in patient with mandibular parasymphysis fracture. This study fills the gap by providing sound evidence on the preferred steroid option to help clinicians have more data to make decisions and improve patients' health. The result of this research will then be added to the evidence-based protocols for the treatment of parasymphysis fractures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 to 40.

Both Gender.

Fracture less than a week old.

Isolated mandibular parasymphysis fractures.

Disqualifiers

1. Immunocompromised patients (due to increased risk of infection and complications).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    single dose of dexamethasone 8 mg (2 mL) administered submucosally at the surgical site 30 minutes before incision.

  • Methylprednisolone (Corticosteroid)

    Drug

    a single dose of methylprednisolone 40 mg (2 mL) will be administered submucosally at the surgical site 30 minutes before incision.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Dexamethasone groupActive comparator 1 intervention
Group B: Methylprednisolone groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

facial Edema

Edema will be assessed in millimeters via measuring tape and assessed via the 9-line method at baseline, 24 hours and 72 hours after surgery. It measures edema at 9 standardized facial landmarks bilaterally (gonion to lateral canthus, tragus to ala of the nose, tragus to commissure of the lip, tragus to midline of the chin and gonion to gonion)

Time frame
at baseline, 24 hours and 72 hours after surgery
2

pain intensity

: Visual Analog Scale (VAS) will be used to evaluate the pain at the baseline, 24 hours and 72 hours after the surgery. The axis is a 10-centimeter line with the endpoints showing 0 which is no pain, and 10 which is the most severe pain. Patients will put a line where they think their pain level is, and this will be recorded

Time frame
at baseline, 24 hour and 72 hour postoperatively

Secondary outcomes

1

serum C-reactive protein (inflammation)

It will be measured in mg/dL at baseline, 24- and 72-hours post-op using the hospital laboratory's standard immunoassay method.

Time frame
baseline, 24- and 72-hours post-op
2

rescue analgesia

. Rescue analgesia will be given if VAS ≥ 4, using a fixed dose of tramadol 50 mg IV/IM (single dose). If pain persists after 6-8 hours, the same 50 mg dose may be repeated, not exceeding 400 mg in 24 hours. Total rescue analgesic consumption within 72 hours will be recorded as a secondary outcome.

Time frame
24 hour to 72 hour after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nishtar Medical University

Lead sponsor

University of Health Sciences Lahore

Sponsor institution

Source ClinicalTrials.gov
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