Analgesic Efficacy of a New Immediate‐Release/Extended‐Release Formulation of Ibuprofen: Results From Single‐ and Multiple‐Dose Postsurgical Dental Pain Studies

Abstract

Analgesic effects of ibuprofen immediate‐release/extended‐release (IR/ER) 600‐mg tablets were evaluated in 2 randomized, double‐blind, placebo‐controlled dental pain studies. Patients 16–40 years old with moderate–severe pain following third‐molar extraction received single‐dose ibuprofen 600 mg IR/ER (formulation A or B), naproxen sodium 220 mg, or placebo (2:2:2:1; study 1) or 4 doses of ibuprofen 600 mg IR/ER (formulation A) or placebo (1:1; study 2). In study 1 (n = 196), mean (standard deviation [SD]) time‐weighted sum of pain intensity difference scores for placebo, ibuprofen IR/ER A, ibuprofen IR/ER B, and naproxen, respectively, were 0.05 (9.2), 16.87 (9.4), 17.34 (10.5), and 12.66 (10.0) over 0–12 hours and ‐0.03 (4.1), 6.57 (4.4), 7.14 (5.2), and 5.14 (5.0) over 8–12 hours (all P < .001 vs placebo). In study 2 (n = 106), mean (SD) time‐weighted sum of pain relief and pain intensity difference scores were 18.2 (20.0) versus 41.5 (21.0) at 0–12 hours and 10.3 (12.0) versus 18.4 (12.1) at 8–12 hours for placebo versus ibuprofen IR/ER, respectively (P < .001 for both); efficacy was sustained over each of the four 12‐hour dosing intervals with ibuprofen. Gastrointestinal adverse events predominated with placebo both after study medication administration and after rescue medication use, if applicable. Ibuprofen 600 mg IR/ER provided safe and effective analgesia after single and multiple doses.

Design of 3D multi-layered electrospun membranes embedding iron-based layered double hydroxide for drug storage and control of sustained release

“…[27] Besides, in this case, LDHs compositions presented only Al 3+ as trivalent cations, an exogenous metal. Valarezo et al [27] [33,35] and postoperative antibiotics, [36] anaesthetics [37] and anti-inflammatories, [34] content was substituted by Fe 3+ cations (endogenous) in the LDHs composition.…”

A Meta-Analysis of the Analgesic Efficacy of Single-Doses of Ibuprofen Compared to Traditional Non-Opioid Analgesics Following Third Molar Surgery

“…The assessment was done with 15 articles. Six clinical studies were in favor of ibuprofen, two reports presented similar analgesic effects, three assays showed no conclusions about the analgesic efficacy of ibuprofen, and four clinical trials informed a result against this drug [ 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 ] ( Figure 2 ; Table S1 ).…”

Clinical Trial of Combination of Acetaminophen, Ibuprofen and Caffeine on Pain Relief and Analgesic Use After Impacted Lower Third Molar Surgery

“…According to various observations, moderate-to-severe pain often accompanies third molar surgery during the first 12 hours after surgery, and thus, this time should be considered as a gold time for selecting appropriate medication to relieve surgical pain. Each of the pointed drugs is usually recommended for mild to moderate pain (18); however, the pain intensity associated with removal of impacted third molars is frequently moderate to severe and calls for more effective drugs or a combination of the effective drugs (19). Thus, our study has provided a stringent test for a combination of a novel approach including coadministration of acetaminophen, ibuprofen, and caffeine to examine their synergistic effect on relieving pain within 8 hours after surgery.…”