ibuprofen-arginine and Pain--Postoperative

This study evaluated the effectiveness of 400 mg ibuprofen arginate either as a pre-emptive (PRE group) or postoperative (POST group) analgesic using a common dental pain model.. A randomized double-blind crossover clinical trial involving a series of consecutive patients admitted for bilateral third molar surgery. Results were analysed according to the self-reported pain score and the pattern of rescue medication taken.. The mean pain score ranged from 0.73 to 1.60 for the PRE group and 0.47 to 1.41 for the POST group among 30 included subjects. The mean time point when first rescue medication taken was 7.3 hours and 8.3 hours postoperative, respectively. Nine patients (30 per cent) in the PRE group and 12 patients (40 per cent) in the POST group took no rescue medication. There was no statistically significant difference for all parameters between groups, while a majority (53 per cent) found the drug "good" to "excellent" in both groups.. Ibuprofen arginate may be considered effective in reducing surgically induced moderate to severe pain when administered either pre-operatively or postoperatively due to the reported relatively low pain score, less consumption of rescue medication, delayed onset of pain, good number of pain-free patients and a high rating in the global assessment score.

Topics: Adult; Analgesics, Non-Narcotic; Arginine; Cross-Over Studies; Double-Blind Method; Drug Combinations; Female; Humans; Ibuprofen; Male; Molar, Third; Pain Measurement; Pain, Postoperative; Patient Satisfaction; Postoperative Care; Premedication; Surveys and Questionnaires; Tooth Extraction; Young Adult

The analgesic efficacy of an arginine salt of ibuprofen was compared to one of the commercially available forms of conventional ibuprofen in a 500-patient clinical trial in postoperative dental pain. Patients were administered a single dose of ibuprofen arginate (200 mg or 400 mg), conventional ibuprofen (200 mg or 400 mg), orplacebo in this double-blind, randomized, parallel-group trial. Results demonstrated that ibuprofen arginate was a safe and effective analgesia that was superior to conventional ibuprofen in both the amount of pain relief achieved and the time to onset of pain relief. Onset of analgesia, assessed as the median amount of time to achieve meaningful pain relief, was reached after 32 and 31 minutes with ibuprofen arginate 200 and 400 mg, respectively, and 64 and 58 minutes with conventional ibuprofen 200 and 400 mg, respectively (p < 0.05). Patients treated with ibuprofen arginate rated its overall effectiveness higher than those patients treated with conventional ibuprofen. Adverse event profiles were similar across all treatment groups.

Topics: Adolescent; Adult; Analgesics, Non-Narcotic; Arginine; Dose-Response Relationship, Drug; Drug Combinations; Female; Humans; Ibuprofen; Male; Pain, Postoperative; Time Factors; Tooth Extraction

Because of its enhanced pharmacokinetic characteristics, ibuprofen arginate might be expected to provide faster pain relief than standard ibuprofen formulations in patients experiencing acute pain.. This study assessed the analgesic efficacy, speed of onset, and tolerability of ibuprofen arginate compared with a commercially available form of ibuprofen in patients with postoperative dental pain.. Patients were randomized to receive ibuprofen arginate 200 or 400 mg, ibuprofen 200 or 400 mg, or placebo in this multicenter, double-blind, double-dummy, parallel-group trial. Patients were observed for 6 hours after administration of a single dose of study medication. A repeated-dose, open-label phase followed. Pain intensity and pain relief were measured using traditional verbal descriptor scales; onset of analgesia was assessed using 2 stopwatches to measure the time to achievement of specific pain relief criteria.. A total of 498 patients (219 men, 279 women; mean age, 21.5 years) participated in this study. Baseline pain was moderate in 388 patients (78%) and severe in 110 patients (22%). Meaningful pain relief was reached after a median of 29 and 28 minutes with ibuprofen arginate 200 and 400 mg, respectively, and after 52 and 44 minutes with ibuprofen 200 and 400 mg, respectively (all, P < 0.05). The percentages of patients who achieved meaningful pain relief within the first hour after treatment were 77.6% and 83.7% for ibuprofen arginate 200 and 400 mg, respectively, 61.0% and 63.0% for ibuprofen 200 and 400 mg, respectively, and 39.8% for placebo. The differences between ibuprofen arginate and ibuprofen were statistically significant (both doses, P < 0.05). Significantly greater numbers of patients achieved meaningful pain relief with ibuprofen arginate 400 mg compared with placebo from 20 minutes through 6 hours and with ibuprofen arginate 200 mg from 30 minutes through 6 hours (P < 0.05). Compared with placebo, a greater number of patients achieved meaningful pain relief with ibuprofen 400 mg from 45 minutes through 6 hours; with ibuprofen 200 mg. the corresponding interval was from I through 6 hours. After the first hour, pain reduction was similar for the similar doses of the 2 ibuprofen preparations. Median remedication times with both doses of ibuprofen arginate were similar to those with both doses of ibuprofen, ranging from 4.0 to 5.2 hours. Adverse-event profiles were similar between the 2 active medications.. Ibuprofen arginate was effective in this population of patients experiencing moderate to severe pain after surgical extraction of > or = 1 impacted third molar, with 16 to 24 minutes' faster time to meaningful pain relief than with ibuprofen. The 2 formulations had similar tolerability profiles.

Topics: Adult; Analgesics, Non-Narcotic; Arginine; Dose-Response Relationship, Drug; Double-Blind Method; Drug Combinations; Female; Humans; Ibuprofen; Male; Pain Measurement; Pain, Postoperative; Tooth Extraction

Ibuprofen is a safe and effective analgesic, but some formulations have a slow onset of action. Ibuprofen arginate is a rapidly absorbed salt designed to promote more rapid onset of analgesia. A clinical trial was conducted in 226 patients with postoperative dental pain to assess the analgesic efficacy and speed of onset of the arginine salt of ibuprofen compared with one of the commercially available forms of ibuprofen. Patients were administered a single dose of either ibuprofen arginate (200 mg or 400 mg), ibuprofen (200 mg or 400 mg), or placebo in this double-blind, randomized trial. To determine the onset of action of the study medication patients were required to note time to "any" pain relief and then time to "meaningful" pain relief, using the two-stopwatch method. Pain intensity and relief were assessed using traditional categorical scales over a 6-h period. Meaningful pain relief was achieved in 42 min and 24 min for ibuprofen arginate 200 mg and 400 mg, respectively, compared with 50 min and 48 min for ibuprofen 200 mg and 400 mg, respectively ( P<0.05). The results for the measurements of analgesic effectiveness [sum of pain intensity difference, total pain relief (TOTPAR), peak pain relief and overall evaluation of treatment] all showed that both doses of ibuprofen arginate and both doses of ibuprofen were significantly better than placebo and both 200-mg and 400-mg ibuprofen arginate doses were significantly better than ibuprofen 200 mg for peak pain relief. Mean plasma ibuprofen concentrations at 30 min and 60 min, respectively, were: ibuprofen arginine 200 mg, 13.9 micro g/ml and 15.7 micro g/ml; ibuprofen arginine 400 mg, 29.5 micro g/ml and 29.3 micro g/ml; ibuprofen 200 mg 2.5 micro g/ml and 5 micro g/ml; ibuprofen 400 mg, 2.3 micro g/ml and 7.4 micro g/ml. ( P<0.05). Adverse event profiles were similar across treatment groups. These results overall suggest that ibuprofen arginate when taken at doses equivalent to commercially available ibuprofen formulations produces analgesia that is faster in onset.

Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Arginine; Double-Blind Method; Drug Combinations; Female; Humans; Ibuprofen; Male; Oral Surgical Procedures; Pain, Postoperative; Time Factors; Tooth Extraction; Treatment Outcome