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

Study Overview
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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.

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

Conditions
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Pain, Edema, Trismus

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Diclofenac Sodium associated with Codeine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Dexamethasone 8 mg, one capsule single preoperative dose. | Drug: Dexamethasone<br>* Dexamethasone 8 mg<br>* Other names: Dexamethasone Acetate;|
| Experimental: Diclofenac Sodium associated with Codeine<br>Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose. | Drug: Diclofenac Sodium associated with Codeine<br>* Diclofenac Sodium 50 mg associated with Codeine 50 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-surgical swelling of third molar extraction determined using linear measures in the face | 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 | 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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption |  | Up to seven days post-surgical | 
| Duration of surgery |  | Up to seven days post-surgical | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain measurement, edema, trismus