Mesut Sener1, Zafer Ozgur Pektas2, Ismail Yilmaz3, Ayda Turkoz1, Sina Uckan1, Asli Donmez1, Gulnaz Arslan1. 1. Department of Anesthesiology and Reanimation, Faculty of Medicine, Baskent University, Ankara, Turkey. 2. Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, easkent University, Ankara, Turkey. 3. Department of Otolaryngology, Head and Neck Surgery, Faculty of Medicine, easkent University, Ankara, Turkey.
Abstract
BACKGROUND: Preemptive analgesia used for postsurgical pain management has been shown to reduce the requirements of postoperative analgesics. OBJECTIVE: The aim of this study was to compare the preemptive analgesic effects of diflunisal, naproxen sodium, meloxicam, acetaminophen, and rofecoxin (no longer available in some markets) in patients undergoing ambulatory dental surgery and the need for postoperative pain management in these patients. METHODS: This prospective, randomized, single-blind study was conducted at the Departments of Anesthesiology and Reanimation and Oral and Maxillofacial Surgery, Baskent University, Adana Teaching and Medical Research Center, Adana, Turkey. Turkish outpatients aged ≥ 16 years with American Society of Anesthesiologists physical status 1 (ie, healthy) and scheduled to undergo surgical extraction of an impacted third molar were enrolled. Patients were randomly assigned to receive diflunisal 500 mg, naproxen sodium 550 mg, meloxicam 7.5 mg, acetaminophen 500 mg, or rofecoxib 12.5 mg. All medications were administered orally 1 hour before surgery as preemptive analgesia and after surgery if needed, up to the maximum recommended dose. Surgery was performed with the patient under local anesthesia (articaine hydrochloride). Pain intensity was assessed using a 100-mm visual analog scale (VAS) (0 = none to 100 = worst possible pain) at 2, 4, 6, and 12 hours after ambulatory surgery. The use of additional analgesics was recorded for 24 hours using patient diaries. Postoperative adverse events were recorded using the diaries. RESULTS:One hundred fifty patients (108 women, 42 men; mean [SE] age, 26.8 [0.6] years; 30 patients per group) had data available for analysis. Demographic data were similar between the 5 groups. No significant differences in mean VAS scores were found between the 5 groups at any time point. All mean VAS scores indicated minor pain. The rate of additional postoperative analgesics required was significantly lower in the diflunisal group compared with groups receiving naproxen sodium, meloxicam, acetaminophen, and rofecoxib (3 [10%] patients vs 11 [37%], 15 [50%], 15 [50%], and 14 [47%] patients, respectively; all, P < 0.05). Bleeding at the surgical site was reported in 2 patients each in the diflunisal, naproxen sodium, meloxicam, and acetaminophen groups, and in 1 patient in the rofecoxib group; the between-group differences were not significant. No significant differences in the prevalences of other adverse effects (eg, nausea, vomiting, allergy, gastrointestinal symptoms) were found between the 5 treatment groups. CONCLUSIONS: In the present study in patients undergoing third molar extraction, adequate preemptive analgesia, based on VAS scores, was found with all of the nonopioid analgesic agents used. Fewer patients required rescue medication with diflunisal. All 5 study drugs were similarly well tolerated.
RCT Entities:
BACKGROUND: Preemptive analgesia used for postsurgical pain management has been shown to reduce the requirements of postoperative analgesics. OBJECTIVE: The aim of this study was to compare the preemptive analgesic effects of diflunisal, naproxen sodium, meloxicam, acetaminophen, and rofecoxin (no longer available in some markets) in patients undergoing ambulatory dental surgery and the need for postoperative pain management in these patients. METHODS: This prospective, randomized, single-blind study was conducted at the Departments of Anesthesiology and Reanimation and Oral and Maxillofacial Surgery, Baskent University, Adana Teaching and Medical Research Center, Adana, Turkey. Turkish outpatients aged ≥ 16 years with American Society of Anesthesiologists physical status 1 (ie, healthy) and scheduled to undergo surgical extraction of an impacted third molar were enrolled. Patients were randomly assigned to receive diflunisal 500 mg, naproxen sodium 550 mg, meloxicam 7.5 mg, acetaminophen 500 mg, or rofecoxib 12.5 mg. All medications were administered orally 1 hour before surgery as preemptive analgesia and after surgery if needed, up to the maximum recommended dose. Surgery was performed with the patient under local anesthesia (articaine hydrochloride). Pain intensity was assessed using a 100-mm visual analog scale (VAS) (0 = none to 100 = worst possible pain) at 2, 4, 6, and 12 hours after ambulatory surgery. The use of additional analgesics was recorded for 24 hours using patient diaries. Postoperative adverse events were recorded using the diaries. RESULTS: One hundred fifty patients (108 women, 42 men; mean [SE] age, 26.8 [0.6] years; 30 patients per group) had data available for analysis. Demographic data were similar between the 5 groups. No significant differences in mean VAS scores were found between the 5 groups at any time point. All mean VAS scores indicated minor pain. The rate of additional postoperative analgesics required was significantly lower in the diflunisal group compared with groups receiving naproxen sodium, meloxicam, acetaminophen, and rofecoxib (3 [10%] patients vs 11 [37%], 15 [50%], 15 [50%], and 14 [47%] patients, respectively; all, P < 0.05). Bleeding at the surgical site was reported in 2 patients each in the diflunisal, naproxen sodium, meloxicam, and acetaminophen groups, and in 1 patient in the rofecoxib group; the between-group differences were not significant. No significant differences in the prevalences of other adverse effects (eg, nausea, vomiting, allergy, gastrointestinal symptoms) were found between the 5 treatment groups. CONCLUSIONS: In the present study in patients undergoing third molar extraction, adequate preemptive analgesia, based on VAS scores, was found with all of the nonopioid analgesic agents used. Fewer patients required rescue medication with diflunisal. All 5 study drugs were similarly well tolerated.