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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02665533
Enrollment
18
Registered
2016-01-27
Start date
2016-01-31
Completion date
2016-07-31
Last updated
2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema, Pain, Trismus

Keywords

pain measurement, edema, trismus

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.

Interventions

DRUGDexamethasone

Dexamethasone 8 mg

DRUGDiclofenac Sodium associated with Codeine

Diclofenac Sodium 50 mg associated with Codeine 50 mg

Sponsors

Federal University of the Valleys of Jequitinhonha and Mucuri
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-surgical swelling of third molar extraction determined using linear measures in the faceUp to seven days post-surgicalDuring 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 openingUp to seven days post-surgicalDuring 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 scaleUp to seven days post-surgicalThe 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

MeasureTime frame
Analgesic consumptionUp to seven days post-surgical
Duration of surgeryUp to seven days post-surgical

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026