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Completed

NCT Number: NCT02665533

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

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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Key information

Conditions

Pain Edema Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Trismus

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 8 mg

Other names: Dexamethasone Acetate

Diclofenac Sodium associated with Codeine

Drug

Diclofenac Sodium 50 mg associated with Codeine 50 mg

Primary outcomes

  1. Post-surgical swelling of third molar extraction determined using linear measures in the face

    Time frame: 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.

  2. Post-surgical trismus of third molar extraction determined by maximum mouth opening

    Time frame: 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.

  3. Post-surgical pain of third molar extraction using visual analogic scale

    Time frame: 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

  1. Analgesic consumption

    Time frame: Up to seven days post-surgical

  2. Duration of surgery

    Time frame: Up to seven days post-surgical

Sponsors and collaborators

Lead sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2016
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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