Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery

August 18, 2016 updated by: Federal University of the Valleys of Jequitinhonha and Mucuri
The main aim of the study is to investigate the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The surgery of third molar is usually associated with important post-surgical sequelae. The damage caused to tissue and bone may result in considerable pain, edema and trismus. The symptoms start gradually, peaking in 2 days after the extraction. The use of medications such as dexamethasone and diclofenac associated to codeine may support the prevention of post-surgical pain. This clinical trial aim compare the the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

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

  • Brazil
    • Minas Gerais
      • Diamantina, Minas Gerais, Brazil, 39100000
        • Universidade Federal dos Vales do Jequitinhonha e Mucuri

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with indication of asymptomatic bilateral extractions of lower third molars;
  • Aged 18 years or older;
  • Have a good health and no disease;

Exclusion Criteria:

  • Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
Dexamethasone 8 mg, one capsule single preoperative dose.
Drug: Dexamethasone
Dexamethasone 8 mg
Other Names:
  • Dexamethasone Acetate
Experimental: Diclofenac Sodium associated with Codeine
Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.
Drug: Diclofenac Sodium associated with Codeine
Diclofenac Sodium 50 mg associated with Codeine 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-surgical swelling of third molar extraction determined using linear measures in the face
Time Frame: Up to seven days post-surgical
During the post-surgical intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face.
Up to seven days post-surgical
Post-surgical trismus of third molar extraction determined by maximum mouth opening
Time Frame: Up to seven days post-surgical
During the post-surgical intervals of 24, 48 and 72 hours and seven days, the trismus was determined by maximum mouth opening.
Up to seven days post-surgical
Post-surgical pain of third molar extraction using visual analogic scale
Time Frame: Up to seven days post-surgical
The post-surgical pain was self-recorded by the patient using visual analogic scale in intervals of 24, 48 and 72 hours and seven days.
Up to seven days post-surgical

Secondary Outcome Measures

Outcome Measure
Time Frame
Analgesic consumption
Time Frame: Up to seven days post-surgical
Up to seven days post-surgical
Duration of surgery
Time Frame: Up to seven days post-surgical
Up to seven days post-surgical

Collaborators and Investigators

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

Sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Investigators

  • Principal Investigator: Thiago Lima, Federal University of the Valleys of Jequitinhonha and Mucuri

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

January 1, 2016

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.354.720

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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