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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, o...
Contexts in source publication
Context 1
... with naproxen sodium (Table 2). PID and pain relief scores were significantly higher, indicating improvement, in the pooled ibuprofen group compared with naproxen at 45 minutes (pain relief only) and at 2, 3, 4, 5, 6, 7, 8, 9, 10, and 12 hours (for PID and pain relief); there were no significant differences at points > 12 hours. ...
Context 2
... = .026; Table 2). Time to meaningful pain re- lief occurred significantly sooner with each active treatment compared with placebo (P < .001); ...
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Drug distribution in an organism depends largely on the binding degree of drugs with blood serum proteins like albumin. Only free fraction of the drug can induce a therapeutic effect. A different affinity of particular drugs to proteins is also one of the reasons of the occurrence of drug interactions. It was decided to investigate if the immobilis...
Citations
... Long-acting formulation of ibuprofen offered sustained pain relief in surgical pain model. It is assumed that the efficacy of the longer-acting formulation of ibuprofen demonstrated in surgical pain model would extend to other types of persistent pain [6]. ...
... Immediate-release/extended-release formulation of ibuprofen was used for postoperative pain management after the third molar extraction. It offered sustained pain relief in the surgical pain model thus it was assumed that the efficacy of the longer-acting formulations of ibuprofen demonstrated in the surgical pain model would extend to other types of persistent pain [6]. To date, there are no clinical studies on the effect of ibuprofen SR for endodontic pain management. ...
The aim of this study was to assess the effect of ibuprofen sustained release (SR) oral premedication on the efficacy of buccal infiltration (BI) with intraoperative and postoperative pain after single-visit root canal treatment. Sixty patients diagnosed with symptomatic irreversible pulpitis and apical periodontitis in mandibular molar were divided into two groups. Group SR received ibuprofen SR 800 mg and group PL received placebo capsule 1 h before 3.6 mL articaine BI injection. Pain was recorded using a modified visual analogue scale and postoperatively at intervals 6, 24 and 48 h. Group SR showed a significantly higher anaesthetic success rate (73.3%) compared to group PL (46.7%) (p < 0.05). Intraoperative and postoperative pain was significantly higher in group PL compared to group SR (p < 0.05). Premedication of ibuprofen SR improved the efficacy of primary BI in mandibular molars with symptomatic irreversible pulpitis and decreased postoperative pain at 6 and 48 h.
... Pain intensity difference was calculated as the difference between the pain VAS score reported after each exercise session and the pre-exercise/baseline score. [30][31][32] ...
Purpose
A randomized, double-blind, placebo-controlled cross-over study was conducted to investigate the efficacy and safety of E-PR-01, a proprietary formula containing Vitex negundo and Zingiber officinale, on knee joint discomfort due to pain.
Patients and Methods
Forty adults aged 20–60 years with self-reported pain score of ≤30 mm at rest and ≥60 mm post-exertion on a 100-mm visual analog scale (VAS) were randomized in a 1:1 ratio to receive either the E-PR-01 (200 mg twice daily) or placebo for 5 days. The primary outcome was time to achieve meaningful pain relief (MPR) (≥40% reduction in post-exertion pain VAS score from baseline) post-single dose of intervention on day 1 compared to placebo. The secondary outcomes were post-exertion pain intensity difference (PID) at 2-, 3- and 4-hours and time-weighted sum of pain intensity difference (SPID) over 4 hours post single dose on day 1; post-exertion VAS score at 4 hours’ post-intervention on day 5; percentage of responders on day 1; and physical efficiency as assessed by the total duration of exercise sessions completed after single dose of IP compared to placebo.
Results
The average time to achieve MPR was 3.38 hours, 32.50% of participants achieved it in the E-PR-01 group post single-dose administration on day 1 as opposed to the placebo where no participant achieved MPR. There were significant intergroup differences in PID (−23.58 vs 2.45 mm) and SPID (−67.48 vs −0.08 mm) at 4 hours of E-PR-01 and placebo administration on day 1. 95% of participants in the IP group experienced some degree of pain relief within 2 hours compared to 37.5% in the placebo group.
Conclusion
A single dose of E-PR-01 provided a statistically significant as well as clinically meaningful reduction in exercise-induced knee joint discomfort within 4 hours of administration.
... Pain intensity after removal of these teeth is often moderate to severe, and requires effective medication or a multimodal strategy with combinations of different medications (Christensen et al. 2016). Asadi et al. (2017) showed that a combined NSAID (600 mg acetaminophen, 400 mg ibuprofen, and 15 mg caffeine) treatment reduced pain intensity in the first 8 postoperative hours. ...
This study aimed to evaluate the scientific evidence on the effect of preemptive drug coadministration (PDC) for relieving inflammatory events (pain, swelling, and trismus) in mandibular third molar surgery. A PROSPERO-registered systematic review (CRD42022314546) was conducted according to the PRISMA guide. The searches were carried out in six primary databases and the gray literature. Studies not written in languages with the Latin alphabet (Roman) were excluded. Potential randomized controlled trials (RCTs) were screened for eligibility. Cochrane’s Risk of Bias-2.0 (RoB) tool was assessed. A synthesis without meta-analysis (SWiM) based on a vote counting and an effect direction plot. Nine studies (low RoB) fulfilled the eligibility criteria and were included for data analysis, with a total of 484 patients. PDC mostly involved corticosteroids (Cort) and non-steroidal anti-inflammatory drugs (NSAIDs). PDC of Cort and other drugs mainly reduced pain scores (6 and 12 h postoperatively) and swelling (48 h postoperatively). PDC of NSAIDs and other drugs mainly reduced pain scores at 6, 8, and 24 h follow-up; swelling and trismus intensity ameliorated at 48 h postoperatively. The most frequently prescribed rescue medication was paracetamol, dipyrone, and paracetamol plus codeine. Results from individual studies have shown reduced consumption of ingested rescue analgesics. In summary, the available evidence from clinical trials included in this SWiM suggests that PDC may provide benefits in reducing the severity of inflammatory outcomes related to mandibular third molar surgery, especially the pain scores in the first hours after surgery, and the rescue analgesic consumption during the postoperative period.
... This long-acting ibuprofen formulation could deliver sustained concentrations of drug over a prolonged period of time, thereby reducing dosing frequency and ensuring more consistent control of long-lasting pains. 68,69 For more detailed studies of TUS-84 on drug delivery, we also performed the loading and release of captopril. TGA trace of captopril-loaded TUS-84 revealed 16 wt % loading of captopril in TUS-84 ( Figure S28). ...
Three-dimensional (3D) covalent organic frameworks (COFs) exemplify a new generation of crystalline extended solids with intriguing structures and unprecedented porosity. Notwithstanding substantial scope, the reticular synthesis of 3D COFs from pre-designed building units leading to new network topologies yet remains a demanding task owing to the shortage of 3D building units and inadequate reversibility of the linkages between the building units. In this work, by linking a tetragonal prism (8-connected) node with a square planar (4-connected) node, we report the first 3D COF with scu-c topology. The new COF, namely, TUS-84, features a two-fold interpenetrated structure with well-defined porosity and a Brunauer-Emmett-Teller surface area of 679 m2 g-1. In drug delivery applications, TUS-84 shows efficient drug loading and sustained release profile.
... A total of 1281 articles were identified in PubMed, of which 17 were fully evaluated with the Cochrane Collaboration's risk of bias tool and, finally, only 15 met the requirements of our study [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] (Figure 1). groups (200 and 400 mg) and two meclofenamate groups (50 and 100 mg)) [21]. ...
... A total of 1281 articles were identified in PubMed, of which 17 were fully evaluated with the Cochrane Collaboration's risk of bias tool and, finally, only 15 met the requirements of our study [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] (Figure 1). ...
... 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). ...
The purpose of this systematic review was to determine the analgesic efficacy and adverse effects of ibuprofen in comparison with other traditional non-opioid analgesics after third molar surgery. A total of 17 full texts were identified in PubMed and assessed using the Cochrane Collaboration’s risk of bias tool by two independent researchers. The sum of pain intensity differences, total pain relief, the overall evaluation, the number of patients requiring rescue analgesics, and adverse effects were collected. Data were analyzed using the Review Manager Software 5.3. for Windows. A total of 15 articles met the criteria. The qualitative and quantitative analysis showed that ibuprofen is more effective to relieve post-operative dental pain than acetaminophen, meclofenamate, aceclofenac, bromfenac, and aspirin. Moreover, ibuprofen and traditional non-steroidal anti-inflammatory drugs have a similar safety profile. In conclusion, ibuprofen 400 mg appears to have good analgesic efficacy and a safety profile similar to other traditional non-steroidal anti-inflammatory drugs after third molar surgery.
... The dosage of 1200 mg daily was used because it was expected a low postoperative pain of the studied groups, due to the characteristics of the inclusion criteria of this clinical trial. The 12-h interval is reported for lower severity cases with good analgesic effect [33][34][35]. ...
The aim of the study was to compare the effect of Ibuprofen and the application of photobiomodulation therapy protocol on the reduction of postoperative pain in endodontically treated teeth using a randomized clinical trial design. Seventy patients, diagnosed with symptomatic irreversible pulpitis, were selected. Treatment was performed by a single operator; a reciprocal system was used to prepare the canals; they were obturated using the Tagger’s hybrid technique and coronally sealed with glass-ionomer cement. After treatment, patients were randomly divided into 2 groups. In the active control group, two Ibuprofen 600 mg tablets were administered within a 12-h interval. In the photobiomodulation therapy group, the irradiation was applied after treatment. The evaluation of postoperative pain was performed by another researcher blinded to the groups at 6, 12, 24, and 72 h intervals after treatment. To measure the outcome, two pain scales were used: numerical rate scale (NRS) and verbal rate scale (VRS). Data were analyzed using the chi-square, Mann-Whitney, and Wilcoxon paired tests. Outcome was superior with photobiomodulation therapy at 6 h (p < 0.001), 12 h (p = 0.005), and 24 h (p < 0.001) intervals compared with Ibuprofen. The results for the 72 h (p = 0.317) interval were similar, both in the VRS and NRS scales. It may be concluded that the use of photobiomodulation therapy was effective in reducing pain within the first 24 h when compared with the administration of Ibuprofen 600 mg.
... Although a slow release is desired most of the time in medicine's formulation, it is interesting to find mechanisms to modulate the drug release rate from the carrier, in order to adjust the formulation according with the treatment of different diseases, with different bioactive species and administration routes. Examples of a desired faster drug release include the administration of extra dose insulin during meals [32,33] and anti-inflammatories to immediate relief of low or moderate pain [34]. On the other hand, a sustained drug release is intended when long-term drug circulation and treatments are necessary, such as in the administration of basal doses insulin unrelated to meals [33,35] and postoperative antibiotics [36], anaesthetics [37] and anti-inflammatories [34], to avoid infections and severe chronic pains. ...
... Examples of a desired faster drug release include the administration of extra dose insulin during meals [32,33] and anti-inflammatories to immediate relief of low or moderate pain [34]. On the other hand, a sustained drug release is intended when long-term drug circulation and treatments are necessary, such as in the administration of basal doses insulin unrelated to meals [33,35] and postoperative antibiotics [36], anaesthetics [37] and anti-inflammatories [34], to avoid infections and severe chronic pains. In this way, the same work presented a strategy in order to increase and modulate the hydrophilicity of the PLA fibers based on the addition of poly(oxyethylene-b-oxypropylene-b-oxyethylene) (Pluronic) into the processed formulation, leading to a faster drug release. ...
Nowadays polymer dressings are expected to possess multiply functions. Besides acting as physical barriers, dressings may provide for the injured tissue species able to turn wound healing process faster and painless. In this way, dressings can be designed aiming to enable the release of drugs. The possibility to modulate drug release kinetics is a desired characteristic to be achieved in order to turn drug delivery systems adequate to specific treatments. However, hydrophilic drugs and hydrophobic polymers incompatibility hinders such modulation and a long-term release cannot be achieved efficiently. Here we present the design of poly(lactic acid) (PLA) membranes containing iron-based Layered Double Hydroxide (LDH) particles able to storage a hydrophilic anionic drug (derived from the non-steroidal anti-inflammatory naproxen). LDH particles are excellent candidates to compose multifunctional composites. They may present diverse biocompatible compositions, possess an elevated encapsulation capacity and tends to promote drugs sustained release by its own, besides assisting tissues regeneration process. Nanofibrous membranes were prepared by the combination of electrospun PLA and electrosprayed LDH as alternated layers (approach A) and also by both technics performed at the same time (approach B). In approach A, by varying the thickness of the PLA fibrous layers, it was possible to easily modulate the drug release rate. Half of drug content was released after 1, 4 and 17 days for the membranes containing the thinnest, the intermediate and the thicker PLA layers, respectively, and after 56 hours for the membrane prepared by the approach B. Naproxen release was kept for 18 days for the thinnest membrane, 59 days for the membrane prepared by the approach B and 66 days for the thicker membranes. We believe that this work can inspire the development of new functional membranes with tunable drug release profile thanks to the versatile electrospinning and electrospraying techniques.
... Two similar studies of single-dose pain relief (n = 196) or four doses (n = 106) for postsurgical dental pain comparing ibuprofen IR 600 mg, ibuprofen ER 600 mg, naproxen 220 mg, and placebo found ibuprofen 600 mg in single-dose or multiple-dose regimens offered superior pain relief compared to placebo with analgesic effect over 12 h per dose. The onset of effect was about 15 min for IR and 30 min for ER ibuprofen and naproxen [20]. ...
Introduction: Dental pain is primarily treated by dentists and emergency medicine clinicians and may occur because of insult to the tooth or oral surgery. The dental impaction pain model (DIPM) has been widely used in clinical studies of analgesic agents and is generalizable to many other forms of pain.
Areas Covered: The authors discuss the DIPM, which has allowed for important head-to-head studies of analgesic agents, such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and combinations. Postsurgical dental pain follows a predictable trajectory over the course of one to 3 days. Dental pain may have odontic origin or may be referred pain from other areas of the body.
Expert opinion: Pain following oral surgery has sometimes been treated with longer-than-necessary courses of opioid therapy. Postsurgical dental pain may be moderate to severe but typically resolves in a day or two after the extraction. Opioid monotherapy, rarely used in dentistry but combination therapy (opioid plus acetaminophen or an NSAID), was sometimes used as well as nonopioid analgesic monotherapy. The dental impaction pain model has been valuable in the study of analgesics but does not address all painful conditions, for example, pain with a neuropathic component.
... Ibuprofen has an established efficacy for pain relief. Superior analgesic effects have been reported with ibuprofen 400 mg when compared to acetaminophen 1000 mg in several clinical pain conditions [14]. In the Paracetamol, Aspirin, and Ibuprofen New Tolerability study (PAIN study), ibuprofen (up to 1.2 g/day) for 7 days was as well-tolerated as paracetamol and had better tolerability than aspirin [15,16]. ...
Introduction
Low back pain is a common problem worldwide causing deterioration of health and quality of life. Low back pain is often associated with muscle spasm. We investigated the combined effect of muscle relaxants and pain killers for low back pain.
Methods
In this open-label, prospective, multicenter study, patients with acute low back pain received a single tablet of either the fixed dose combination of chlorzoxazone 500 mg and ibuprofen 400 mg (manufacturer: Dr. Reddy’s Laboratories, India) (C + I group) or ibuprofen 400 mg (I group) thrice daily for up to 7 days. Primary outcomes were improvement in pain by Visual Analogue Scale (VAS) and Summed Pain Intensity Difference (SPID) at 3 and 7 days post-treatment.
Results
A total of 406 patients were included in this study. When compared to baseline, the absolute mean change in VAS scores on Day 7 was 62.39 ± 18.78 and 57.34 ± 16.29 in the C + I and I groups, respectively (P = 0.0001). In the C + I and I groups, the mean SPID at Days 3 and 7 were 51.27 ± 24.44 and 47.80 ± 22.91, and 300.82 ± 92.40 and 277.16 ± 81.83, respectively. No deaths or serious adverse events were reported. Common adverse events included gastritis, stomach pain, fever, cold, and headache. At the end of the study, excellent to good response was reported in 94.08% and 77.33% of patients in the C + I and I groups, respectively. Excellent to good tolerability was observed in 96.05% and 89.65% patients in the two groups, respectively.
Conclusion
Fixed dose combination of chlorzoxazone and ibuprofen demonstrated superior efficacy than ibuprofen monotherapy in acute low back pain. Both drugs were well-tolerated and should be considered as judicious therapeutic options in patients with acute low back pain.
... Ibuprofen has an established efficacy for pain relief. Superior analgesic effects have been reported with ibuprofen 400 mg when compared to acetaminophen 1000 mg in several clinical pain conditions [14]. In the Paracetamol, Aspirin, and Ibuprofen New Tolerability study (PAIN study), ibuprofen (up to 1.2 g/day) for 7 days was as well-tolerated as paracetamol and had better tolerability than aspirin [15,16]. ...
Introduction
Low back pain is a common problem worldwide causing deterioration of health and quality of life. Low back pain is often associated with muscle spasm. We investigated the combined effect of muscle relaxants and pain killers for low back pain.
Methods
In this open-label, prospective, multicenter study, patients with acute low back pain received a single tablet of either the fixed dose combination of chlorzoxazone 500 mg and ibuprofen 400 mg (manufacturer: Dr. Reddy’s Laboratories, India) (C + I group) or ibuprofen 400 mg (I group) thrice daily for up to 7 days. Primary outcomes were improvement in pain by Visual Analogue Scale (VAS) and Summed Pain Intensity Difference (SPID) at 3 and 7 days post-treatment.
Results
A total of 406 patients were included in this study. When compared to baseline, the absolute mean change in VAS scores on Day 7 was 62.39 ± 18.78 and 57.34 ± 16.29 in the C + I and I groups, respectively (P = 0.0001). In the C + I and I groups, the mean SPID at Days 3 and 7 were 51.27 ± 24.44 and 47.80 ± 22.91, and 300.82 ± 92.40 and 277.16 ± 81.83, respectively. No deaths or serious adverse events were reported. Common adverse events included gastritis, stomach pain, fever, cold, and headache. At the end of the study, excellent to good response was reported in 94.08% and 77.33% of patients in the C + I and I groups, respectively. Excellent to good tolerability was observed in 96.05% and 89.65% patients in the two groups, respectively.
Conclusion
Fixed dose combination of chlorzoxazone and ibuprofen demonstrated superior efficacy than ibuprofen monotherapy in acute low back pain. Both drugs were well-tolerated and should be considered as judicious therapeutic options in patients with acute low back pain.
Trial Registration
This trial is registered with Clinical Trial Registry of India—CTRI/2016/10/007348.
Funding
Dr. Reddy’s Laboratories Ltd.
