Intravenous Dexamethasone on Postoperative Pain and Complications in Jaw Surgery (DXM-PAIN)

June 24, 2026 updated by: FUNDA ARUN, Selcuk University

Effect of Single Dose Intravenous Dexamethasone on Postoperative Pain and Complications in Jaw Surgery Under General Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients undergoing corticosteroid therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
At the end of the procedure, patients received a single IV dose of Dexamethasone (0.1 mg/kg) before being extubated.
Drug: Dexamethasone
Dexamethasone, single-dose, 0,1mg/ kg IV administered intraoperatively
Other Names:
  • Dekort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IV dexamethasone (DXM) changes postoperative complications
Time Frame: 6 months
Postoperative pain, swelling, and restricted mouth opening are identified as key postoperative concerns. The anti-inflammatory effects of dexamethasone (DXM) are utilized to address these complications.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Investigators

  • Study Chair: Hasan Kucukkolbasi, prof., Selcuk University
  • Study Chair: Emine Taskin, resid., Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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