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

NCT02665533 — Not applicable, Completed, 18 participants, Federal University of the Valleys of Jequitinhonha and Mucuri

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Registry	NCT02665533
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: double, treatment
Enrollment	18 (Actual)
Sponsor	Federal University of the Valleys of Jequitinhonha and Mucuri (Other)
Conditions	Pain, Edema, Trismus
Interventions	Dexamethasone, Diclofenac Sodium associated with Codeine (Drug)
Dates	start 2016-01-01, primary completion 2016-01-01, completion 2016-07-01, first posted 2016-01-27, last updated 2016-08-19
Locations	1 site in Brazil

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Dexamethasone	Active comparator	Drug: Dexamethasone	Dexamethasone 8 mg, one capsule single preoperative dose.
Diclofenac Sodium associated with Codeine	Experimental	Drug: Diclofenac Sodium associated with Codeine	Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.

Dexamethasone (Drug), also known as Dexamethasone Acetate: Dexamethasone 8 mg
Diclofenac Sodium associated with Codeine (Drug): Diclofenac Sodium 50 mg associated with Codeine 50 mg

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 35 Years

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.

+Locations (1)

Facility	City	Country	Status
Universidade Federal dos Vales do Jequitinhonha e Mucuri	Diamantina, Minas Gerais	Brazil

+Investigators

Thiago Lima, Principal investigator, Federal University of the Valleys of Jequitinhonha and Mucuri