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

Sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri (Other)

Overall Status

Completed

CT.gov ID

NCT02665533

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Edema Trismus	Drug: Dexamethasone Drug: Diclofenac Sodium associated with Codeine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Analgesic consumption [Up to seven days post-surgical]
Duration of surgery [Up to seven days post-surgical]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.