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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665533
• Other study ID #: 1.354.720
• Status: Completed
• Phase: N/A
• First received: January 20, 2016
• Last updated: August 18, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: January 2016
• Source: Federal University of the Valleys of Jequitinhonha and Mucuri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Pain
• Trismus

Intervention

Drug:
• Dexamethasone
Dexamethasone 8 mg
• Diclofenac Sodium associated with Codeine
Diclofenac Sodium 50 mg associated with Codeine 50 mg

Locations

Country	Name	City	State
Brazil	Universidade Federal dos Vales do Jequitinhonha e Mucuri	Diamantina	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of the Valleys of Jequitinhonha and Mucuri

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to seven days post-surgical	No
Primary	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.	Up to seven days post-surgical	No
Primary	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.	Up to seven days post-surgical	No
Secondary	Analgesic consumption		Up to seven days post-surgical	No
Secondary	Duration of surgery		Up to seven days post-surgical	No