Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction.

Effectiveness of Non-steroidal Anti-inflammatory Diclofenac and Its Association to the Opioid Codeine for Pain, Swelling and Trismus in the Bilateral Mandibular Third Molar Extraction With a High Degree of Difficulty Model.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02547896

Enrollment

Registered

2015-09-11

Start date

2014-09-30

Completion date

2015-09-30

Last updated

2015-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Third Molar Tooth

Keywords

codeine, diclofenac, impacted third molar tooth

Brief summary

It will be evaluated the clinical efficacy of Diclofenac 50mg (NSAID) compared to its association with Codeine 50mg (opioid) administered in 50 patients requiring extraction of two third molars. After assessing the research parameters, a comparative data analysis, along with the proper application of statistical tests, will provide the basis for an evaluation of both efficiency medications used.

Detailed description

This research will evaluate the clinical efficacy of Diclofenac 50mg (NSAID) compared to its association with Codeine 50mg (opioid) administered in 50 patients aged less than 18 and requiring extraction of two third molars (with very similar positions, whose degree of difficulty is high). It will be assessed the following parameters: 1) onset and duration of surgery after administration of local anesthetic, 2) open mouth prior to surgery, on the 2nd day after the operation and on the 7th day after surgery (removal points), 3) subjective assessment of pain using a visual analog scale, 4) measurement of facial edema in the second day after the operation and on the 7th day after surgery (as compared with the measurements obtained before surgery) and 5) the incidence, type and severity of adverse reactions. The analysis comparative data, along with the proper application of statistical tests, provide the basis for an evaluation of both efficiency medications used.

Interventions

DRUGCodeine + Diclofenac

The patients will receive codeine and diclofenac as pain relief medicine after the surgery

DRUGDiclofenac

The patients will receive only diclofenac

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Impacted lower third molar * not in use of NSAID or opioids in the last one month

Exclusion criteria

* Local anesthetics allergy, * History of gastrointestinal bleeding or ulcers, * Kidney disease, * Asthma, * Allergy or sensitivity to aspirin or any other NSAID or opioids, * Pregnant or nursing woman, * Patients using antidepressant, diuretic or aspirin, * Patients under treatment to quit drugs

Design outcomes

Primary

Measure	Time frame	Description
Higher pain control after lower third molar surgeries with codeine + diclofenac	Seven days after surgery	Reducing pain is measured by visual analogue scale. It is expected that the visual analogue scale (100 mm) presents lower values in patients that underwent surgeries and received the association of codeine + diclofenac compared to whose received only diclofenac. Evaluated periods were 0, 15, 30, 45 min, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 and 96 hours.

Secondary

Measure	Time frame	Description
Adverse effects	Seven days after surgery	Increased reporting of adverse effects during the postoperative period in patients that received codeine + diclofenac assessed by the information contained in the medical records of the patient.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026