Intravenous Dexamethasone on Postoperative Pain and Complications in Jaw Surgery

NCT ID: NCT06787196

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-01-31

Brief Summary

This study aims to evaluate the effect of single-dose intravenous dexamethasone on postoperative pain and other complications in compacted tooth and cyst enucleation procedures performed under general anesthesia.

Detailed Description

During surgery, patients were carefully monitored with standard equipment to track oxygen levels (SpO2), heart activity (ECG), blood pressure, and carbon dioxide levels. General anesthesia was started with medications like thiopental, rocuronium, and fentanyl, and maintained with a mix of oxygen, air, sevoflurane, and remifentanil. Patients were intubated with appropriate tubes, and the surgical team applied a local anesthetic (Articaine with Epinephrine) to the area before starting the procedure. After the surgery, patients were given dexamethasone (DXM) and pantoprazole intravenously, then safely extubated and sent to recovery. All patients were discharged on the same day.

Postoperative recovery was assessed using pain scores (VAS) and physical evaluations. Pain levels were categorized as mild, moderate, or severe, and an analgesic was provided if the score exceeded 3. Facial swelling was measured by comparing pre- and post-surgery facial landmarks, with swelling classified into grades based on the percentage of change. Mouth opening was evaluated with a caliper to check for trismus (jaw stiffness), with results grouped into normal, mild, moderate, or severe grades depending on the degree of restriction. Follow-ups were conducted by an independent clinician on postoperative days 1, 2, and 7.

Conditions

Tooth Extraction Status Nos; Cysts Dental; General Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Dexamethasone

At the end of the procedure, patients received a single IV dose of Dexamethasone (0.1 mg/kg) before being extubated.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Dexamethasone, single-dose, 8 mg IV administered intraoperatively

Interventions

Dexamethasone

Dexamethasone, single-dose, 8 mg IV administered intraoperatively

Intervention Type: DRUG

Other Intervention Names

Dekort

Eligibility Criteria

Inclusion Criteria

• ASA physical status I-II
• underwent split-mouth surgery

Exclusion Criteria

• Patients undergoing corticosteroid therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

FUNDA ARUN

Assistant Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan Kucukkolbasi, prof.

Role: STUDY_CHAIR

Selcuk University

Emine Taskin, resid.

Role: STUDY_CHAIR

Selcuk University

Locations

Funda Arun

Selçuklu, Konya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

F003

Identifier Type: -

Identifier Source: org_study_id