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

Primary Purpose

Pain, Edema, Trismus

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Dexamethasone

Diclofenac Sodium associated with Codeine

About this trial

This is an interventional treatment trial for Pain focused on measuring pain measurement, edema, trismus

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dexamethasone

Diclofenac Sodium associated with Codeine

Arm Description

Dexamethasone 8 mg, one capsule single preoperative dose.

Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.

Outcomes

Primary Outcome Measures

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

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

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

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

Duration of surgery

Full Information

NCT ID

NCT02665533

First Posted

January 20, 2016

Last Updated

August 18, 2016

Sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

1. Study Identification

Unique Protocol Identification Number

NCT02665533

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Edema, Trismus

Keywords

pain measurement, edema, trismus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Description

Dexamethasone 8 mg, one capsule single preoperative dose.

Arm Title

Diclofenac Sodium associated with Codeine

Arm Type

Experimental

Arm Description

Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Dexamethasone Acetate

Intervention Description

Dexamethasone 8 mg

Intervention Type

Drug

Intervention Name(s)

Diclofenac Sodium associated with Codeine

Intervention Description

Diclofenac Sodium 50 mg associated with Codeine 50 mg

Primary Outcome Measure Information:

Title

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

Description

During the post-surgical intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face.

Time Frame