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

• ClinicalTrials.gov Identifier: NCT02665533
• Recruitment Status: Completed
• First Posted: January 27, 2016
• Last Update Posted: August 19, 2016
• Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
• Information provided by (Responsible Party): Federal University of the Valleys of Jequitinhonha and Mucuri

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.

Condition or disease	Intervention/treatment	Phase
Pain; Edema; Trismus	Drug: Dexamethasone; Drug: Diclofenac Sodium associated with Codeine	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery
• Study Start Date: January 2016
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Dexamethasone; Dexamethasone 8 mg, one capsule single preoperative dose.	Drug: Dexamethasone; Dexamethasone 8 mg; Other Name: Dexamethasone Acetate
Experimental: Diclofenac Sodium associated with Codeine; Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.	Drug: Diclofenac Sodium associated with Codeine; Diclofenac Sodium 50 mg associated with Codeine 50 mg

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Analgesic consumption [ Time Frame: Up to seven days post-surgical ]
2. Duration of surgery [ Time Frame: Up to seven days post-surgical ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, Brazil, 39100000

Sponsors and Collaborators

Federal University of the Valleys of Jequitinhonha and Mucuri

Investigators

• Principal Investigator: Thiago Lima; Federal University of the Valleys of Jequitinhonha and Mucuri

More Information

• Responsible Party: Federal University of the Valleys of Jequitinhonha and Mucuri
• ClinicalTrials.gov Identifier: NCT02665533
• Other Study ID Numbers: 1.354.720
• First Posted: January 27, 2016
• Last Update Posted: August 19, 2016
• Last Verified: January 2016

Keywords provided by Federal University of the Valleys of Jequitinhonha and Mucuri:

pain measurement; edema; trismus

Additional relevant MeSH terms:

Trismus; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Dexamethasone; Dexamethasone acetate; Diclofenac; Codeine; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors