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

NCT ID: NCT02665533

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Edema Trismus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexamethasone

Dexamethasone 8 mg, one capsule single preoperative dose.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 8 mg

Diclofenac Sodium associated with Codeine

Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.

Group Type EXPERIMENTAL

Diclofenac Sodium associated with Codeine

Intervention Type DRUG

Diclofenac Sodium 50 mg associated with Codeine 50 mg

Interventions

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Dexamethasone

Dexamethasone 8 mg

Intervention Type DRUG

Diclofenac Sodium associated with Codeine

Diclofenac Sodium 50 mg associated with Codeine 50 mg

Intervention Type DRUG

Other Intervention Names

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Dexamethasone Acetate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of the Valleys of Jequitinhonha and Mucuri

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thiago Lima

Role: PRINCIPAL_INVESTIGATOR

Federal University of the Valleys of Jequitinhonha and Mucuri

Locations

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Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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1.354.720

Identifier Type: -

Identifier Source: org_study_id

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