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

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

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.

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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


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




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665533


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

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Responsible Party: Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier: NCT02665533     History of Changes
Other Study ID Numbers: 1.354.720
First Posted: January 27, 2016    Key Record Dates
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:
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Trismus
Signs and Symptoms
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