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
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Condition or disease | Intervention/treatment | Phase |
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Pain Edema Trismus | Drug: Dexamethasone Drug: Diclofenac Sodium associated with Codeine | Not Applicable |
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.
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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.
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Drug: Diclofenac Sodium associated with Codeine
Diclofenac Sodium 50 mg associated with Codeine 50 mg |
- 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.
- 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.
- 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.
- Analgesic consumption [ Time Frame: Up to seven days post-surgical ]
- 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 |
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.

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
Brazil | |
Universidade Federal dos Vales do Jequitinhonha e Mucuri | |
Diamantina, Minas Gerais, Brazil, 39100000 |
Principal Investigator: | Thiago Lima | Federal University of the Valleys of Jequitinhonha and Mucuri |
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 Key Record Dates |
Last Update Posted: | August 19, 2016 |
Last Verified: | January 2016 |
pain measurement edema trismus |
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 |