Em vista dos problemas gastrointestinais gerados pelo uso do cetoprofeno, a associação do cetoprofeno com o omeprazol está disponível no mercado. No entanto, esta eficácia de associação no controle da dor aguda não foi estabelecida. A extração bilateral de terceiros molares inferiores em posições semelhantes é atualmente o modelo mais utilizado para a avaliação e investigação da eficácia e efeitos farmacológicos de novos compostos para o tratamento da dor aguda pós-operatória. O estudo randomizado e cruzado consistiu na avaliação da eficácia clínica da terapia com cetoprofeno 100 mg (duas vezes ao dia-b.i.d.) versus cetoprofeno 200 mg + omeprazol 20 mg (uma vez ao dia-q.d.) para o controle da dor, do edema e do trismo no modelo bilateral de terceiros molares inferiores em posições semelhantes em duas consultas diferentes, em 50 voluntários. Os voluntários relataram significativamente menos dor pós-operatória em vários períodos pós-operatórios e consumiram menos medicação analgésica de socorro (acetaminofeno 750 mg) durante todo o estudo quando tomaram a combinação de 200 mg de cetoprofeno + 20 mg de omeprazol (q.d.). Após a administração de ambas as drogas do estudo, nenhuma reação adversa gastrointestinal foi relatada pelos voluntários. Além disso, as avaliações das drogas no controle da dor pelos voluntários foram significativamente favoráveis ao cetoprofeno 200 mg + omeprazol 20 mg (q.d.). Para o controle do edema e do trismo, os tratamentos apresentaram resultados semelhantes. Em conclusão, quando os voluntários tomaram 200 mg de cetoprofeno + 20 mg de omeprazol (q.d.), eles relataram significativamente menos dor pós-operatória em vários períodos pós-cirúrgicos e consumiram menos medicação analgésica de socorro durante o estudo comparado com 100 mg de cetoprofeno (b.i.d).
Article • Braz. Dent. J. 29
(2)
• Mar-Apr 2018 • https://doi.org/10.1590/0103-6440201802254 linkcopiar
Efficacy of Ketoprofen With or Without Omeprazole for Pain And Inflammation Control After Third Molar Removal
Autoria
person Luis Fernando Simoneti
person Giovana Maria Weckwerth
person Thiago José Dionísio
person Elza Araujo Torres
person Paulo Zupelari-Gonçalves
person Adriana Maria Calvo
person José Roberto Lauris
schoolDepartment of Pediatric Dentistry, Orthodontics and Community Health, Bauru School of Dentistry, USP - Universidade de São Paulo, Bauru, SP, BrazilUniversidade de São PauloBrazilBauru, SP, BrazilDepartment of Pediatric Dentistry, Orthodontics and Community Health, Bauru School of Dentistry, USP - Universidade de São Paulo, Bauru, SP, Brazil
person Flávio Cardoso Faria
person Carlos Ferreira Santos
Correspondence: Carlos F. Santos, Alameda Octávio Pinheiro Brisolla, 975, 17012-901. Bauru, SP, Brazil. Phone/Fax: +55 14 32358295. e-mail: cfsantos@fob.usp.br
SCIMAGO INSTITUTIONS RANKINGS
Department of Biological Sciences, Bauru School of Dentistry, USP - Universidade de São Paulo, Bauru, SP, BrazilUniversidade de São PauloBrazilBauru, SP, BrazilDepartment of Biological Sciences, Bauru School of Dentistry, USP - Universidade de São Paulo, Bauru, SP, Brazil
Department of Pediatric Dentistry, Orthodontics and Community Health, Bauru School of Dentistry, USP - Universidade de São Paulo, Bauru, SP, BrazilUniversidade de São PauloBrazilBauru, SP, BrazilDepartment of Pediatric Dentistry, Orthodontics and Community Health, Bauru School of Dentistry, USP - Universidade de São Paulo, Bauru, SP, Brazil
Figuras | Tabelas
imageFigure 1: Study flowchart. open_in_new

imageFigure 2 Visual analog scale (VAS) of self-reported postoperative pain scores after lower third molar surgeries assessed at 15, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72 and 96 h. Scores could range from 0 to 100 mm with larger scores indicating increased pain. Data are presented as median and interquartile range (n = 50). * Indicates a p-value ≤ 0.05, Wilcoxon test, for each assessed time period comparing ketoprofen 100 mg b.i.d. and ketoprofen 200 mg + omeprazole 20 mg q.d. open_in_new

imageFigure 3 Self-reported global efficacy of oral ketoprofen 100 mg b.i.d. and ketoprofen 200 mg + omeprazole 20 mg q.d. during the seventh postoperative day as assessed using a 5-level Likert scale (n = 50). The format of the Likert ratings was “excellent,” “very good,” “good,” “fair,” or “poor”. * Indicates a p-value ≤ 0.05, Wilcoxon test for the “excellent” sub-group between research medications. open_in_new

table_chartTable 1:
Parameters evaluated in the study
| Parameter | Unit |
|---|---|
| Quality of anesthesia | 3-point scale: 1) no discomfort during surgery; 2) any discomfort without the need for additional anesthesia; 3) any discomfort with the need for additional anesthesia |
| Overall experience of surgery reported by patient | 5-point scale: 1) “poor”; 2) “fair”; 3) “good”; 4) “very good”; 5) “excellent” |
| Body temperature | Preoperative period, 2nd, 7th postoperative day (oC) |
| Total volume of local anesthetic | mL |
| Onset of anesthetic agent action | Min |
| Total amount of rescue medication (750 mg acetaminophen) | Number of tablets |
| Systolic, diastolic, and mean arterial pressure; heart rate and oxygen saturation* | mmHg; bpm and % SpO2 |
| Intraoperative bleeding | 3-point scale: 1) minimal bleeding; 2) normal bleeding; 3) excessive bleeding |
| Surgery difficulty | 3-point scale: 1) no need for osteotomies without tooth sectioning; 2) need for osteotomies without tooth sectioning; 3) need for osteotomies and tooth sectioning complicated |
| Subjective evaluation of postoperative pain | Visual analog scale (VAS, 0 to 100 mm) |
| Mouth opening | Preoperative period, 2nd, 7th postoperative day (mm) |
| Surgery duration | min |
| Adverse reactions | Observed by the surgeon or reported by the volunteer, during the surgery in the first postoperative hour and during the 2nd and 7th days after surgery. |
| Facial swelling | Preoperative period, 2nd, 7th postoperative day (mm) |
| Quality of wound healing | 7th day; 3-point scale: 1) normal healing without inflammation; 2) delayed healing; 3) healing complicated by inflammation or local infection with or without purulent material |
-
* Dixtal® (model DX2021, DixtalBiomédicaInd and Com Ltda, Marília, SP, ANVISA/MS 10293490035, model number 101503732).
table_chartTable 2
Third molars position according to Pell & Gregory and Winter, number of surgeries without osteotomy and tooth sectioning, number of surgeries with only osteotomy and number of surgeries with osteotomy and tooth sectioning.
| Ketoprofen 100 mg b.i.d. | Ketoprofen 200 mg + Omeprazole 20 mg q.d. | |
|---|---|---|
| IA | 24 | |
| IB | 3 | |
| IC | 0 | |
| IIA | 12 | |
| IIB | 9 | |
| IIC | 2 | |
| IIIA | 0 | |
| IIIB | 0 | |
| IIIC | 0 | |
| Vertical | 27 | |
| Horizontal | 17 | |
| Distoangular | 6 | |
| Mesioangular | 0 | |
| Inverted | 0 | |
| Buccal/Lingual Obliquity | 0 | |
| Surgeries without osteotomy and tooth sectioning | 9 | 9 |
| Surgeries with only osteotomy | 9 | 11 |
| Surgeries with osteotomy and tooth sectioning | 32 | 30 |
-
Pell and Gregory classification based on the amount of tooth covered by the anterior border of the ramus: Class I 3rd molar impaction: Situated anterior to the anterior border of the ramus, Class II 3rd molar impaction: Crown ½ covered by the anterior border of the ramus. Class III 3rd molar impaction: Crown fully covered by the anterior border of the ramus. The depth of the impaction relative to the adjacent tooth (A,B,or C). Class A: the occlusal plane of the impacted tooth is at the same level as the adjacent tooth. Class B: the occlusal plane of the impacted tooth is between the occlusal plane and the cervical line of the adjacent tooth. Class C: the occlusal plane of the impacted tooth is apical to the cervical line of the adjacent tooth. Winter classification: Mesio-Angular: The impacted tooth is tilted toward the 2nd molar in a mesial direction. Disto-Angular: The long axis of the 3rd molar is angled distally / posteriorly away from the 2nd molar. Horizontal: The long axis of the 3rd molar is horizontal. Vertical: The long axis of the 3rd molar is parallel to the long axis of the 2nd molar. Buccal / Lingual Obliquity: In combination with the above, the tooth can be buccally (tilted towards the cheek) or lingually (tilted towards the tongue) impacted. Inverted: In this position, the tooth is displaced in an upside down position, with the crown facing the alveolar nerve.
table_chartTable 3
Self-reported consumption of pain relief medication and pain scores when pain relief medication was consumed
| Drugs | Amount of relief medication (tablets) | Pain score (0 to 100) | Time duration, surgery to 1st relief medication (h) |
|---|---|---|---|
| Ketoprofen 100 mg b.i.d. | 3 [4.5] | 29.7 ± 20.6 | 7.0 [5.7] |
| Ketoprofen 200 mg + Omeprazole 20 mg q.d. | 0.5 [3] * | 27.7 ± 20.2 | 5.1 [5.4] |
-
Numbers reported with ± indicate a mean ± 1 SD, numbers reported with [ ] indicate a median and IRQ* Indicates a p-value ≤ 0.05, Wilcoxon test versus ketoprofen 100 mg b.i.d.
table_chartTable 4
Demographic distribution and intraoperative parameters of 50 volunteers undergoing invasive lower third molar surgeries
| Parameters | Ketoprofen 100 mg b.i.d | Ketoprofren 200 mg + Omeprazole 20 mg q.d. |
|---|---|---|
| Age (years) | 24 ± 5.0 | |
| Male | 17 (34%) | |
| Female | 33 (66%) | |
| Anesthetic (cartridges) | 1.5 [0] | 1.5 [0] |
| Surgery duration (min) | 19.3 ± 5.8 | 21.0 ± 7.7 |
| Onset of local anesthetic (sec) | 116 ± 48 | 113 ± 47 |
| Anesthesia quality (1 to 3) | 1 [0] | 1 [0] |
| Surgery difficulty (1 to 3) | 3 [1] | 3 [1] |
| Intraoperative bleeding (1 to 3) | 1 [0] | 1 [0] |
| Wound-healing evaluation (1 to 3) | 1 [0] | 1 [0] |
| Preoperative period Mouth opening (mm) | 47.3 ± 7.7 | 46.2 ± 6.7 |
| Mouth opening (mm) Second day | 29.9 ± 8.3# | 28.1 ± 7.1# |
| Mouth opening (mm) Seventh day | 38.4 ± 8.8# | 37.1 ± 9.4# |
| Facial measurement (mm) Preoperative period | 378.5± 24.0 | 377.7± 21.4 |
| Facial swelling (mm) Second day | 398.1 ± 23.2# | 394.6 ± 21.9# |
| Facial swelling (mm) Seventh day | 386.1 ± 23.8# | 383.8 ± 22.4# |
| Body temperature (oC) Preoperative period | 36.02 ± 0.77 | 36.06 ± 0.17 |
| Body temperature (oC) Second day | 36.09 ± 0.55 | 36.36 ± 1.10 |
| Body temperature (oC) Seventh day | 35.57 ± 0.50 | 36.00 ± 0 |
-
Numbers reported with ± indicate a mean ± 1 SD, numbers reported with [ ] indicate a median and IRQ. * versus ketoprofen 100 mg b.i.d. and # versus preoperative period.
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