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

Not Applicable

Completed

• Conditions: Pain; Edema; Trismus
• Interventions: Drug: Diclofenac Sodium associated with Codeine; Drug: Dexamethasone

• Registration Number: NCT02665533
• Lead Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri

Brief Summary

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

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 Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Primary Completion: 2016-01
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-27
• Study Completion: 2016-07
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diclofenac Sodium associated with Codeine	Diclofenac Sodium associated with Codeine	Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.
Dexamethasone	Dexamethasone	Dexamethasone 8 mg, one capsule single preoperative dose.

Primary Outcome Measures

Name	Time	Method
Post-surgical swelling of third molar extraction determined using linear measures in the face	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.
Post-surgical trismus of third molar extraction determined by maximum mouth opening	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.
Post-surgical pain of third molar extraction using visual analogic scale	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.

Secondary Outcome Measures

Name	Time	Method
Analgesic consumption	Up to seven days post-surgical
Duration of surgery	Up to seven days post-surgical

Trial Locations

Locations (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri; 🇧🇷 Diamantina, Minas Gerais, Brazil