Ibuprofen blood plasma levels and onset of analgesia.

Background:   Ibuprofen is widely available as an over-the-counter treatment for pain and fever. New formulations are now available, with varying pharmacokinetic profiles. However, few studies have been specifically designed to examine the relationship between ibuprofen plasma levels and onset of analgesia.

Comparison of the analgesic efficacy of concurrent ibuprofen and paracetamol with ibuprofen or paracetamol alone in the management of moderate to severe acute postoperative dental pain in adolescents and adults: a randomized, double-blind, placebo-controlled, parallel-group, single-dose, two-center, modified factorial study.

Background: Combination analgesics may offer improved analgesic efficacy, particularly for moderate to severe pain.

Objective: This study evaluated the analgesic benefits of concurrent ibuprofen and paracetamol compared with each drug used alone in the management of acute postoperative dental pain.

Methods: Healthy patients aged 16 to 40 years undergoing surgical removal of 3 to 4 impacted molars (total impaction score > or = 9) were enrolled in this randomized, double-blind, placebo-controlled, parallel-group, single-dose, 2-center, modified factorial US study.

A single-tablet fixed-dose combination of racemic ibuprofen/paracetamol in the management of moderate to severe postoperative dental pain in adult and adolescent patients: a multicenter, two-stage, randomized, double-blind, parallel-group, placebo-controlled, factorial study.

Background: The combination of ibuprofen and paracetamol may confer analgesic benefits over monotherapy with either agent. In a previous study, an ibuprofen/paracetamol combination provided significantly better analgesic efficacy than comparable doses of ibuprofen or paracetamol alone in patients experiencing moderate to severe acute postoperative pain after extraction of impacted third molars.

Objective: This study compared the efficacy and tolerability of 3 doses of a single-tablet fixed-dose combination (FDC) of ibuprofen and paracetamol (ibuprofen/paracetamol doses of 100 mg/250 mg, 200 mg/500 mg, and 400 mg/1000 mg) with comparable doses of ibuprofen (200 or 400 mg) monotherapy, paracetamol (500 or 1000 mg) monotherapy, and placebo in the 8 hours after surgical removal of 3 to 4 impacted third molars (stage 1) and with placebo over the next 72 hours (stage 2).

Intranasal ketorolac for pain secondary to third molar impaction surgery: a randomized, double-blind, placebo-controlled trial.

Purpose: This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of intranasal (IN) ketorolac in patients who had third molar extraction surgery with bony impactions.

Materials And Methods: After surgery, patients were randomly assigned to receive IN ketorolac 31.5 mg (n = 40) or IN placebo (n = 40).

The time to onset and overall analgesic efficacy of rofecoxib 50 mg: a meta-analysis of 13 randomized clinical trials.

Objective: To determine the time to onset of analgesia of rofecoxib based on a patient-level meta-analysis of randomized, placebo-controlled, postoperative oral surgery pain studies.

Methods: A search on MEDLINE and of Merck data on file was conducted to identify studies that met the inclusion criteria. Meta-analysis inclusion criteria required that patients were treated with a single oral dose of rofecoxib 50 mg when they experienced moderate or severe pain after surgical extraction of > or = 2 third molars; study design involved patient randomization, double-blinding, and matching placebo, and onset data from individual patients were available.

The analgesic efficacy of intramuscular parecoxib sodium in postoperative dental pain.

Background: The parenteral cyclo-oxygenase, or COX, -2 selective inhibitor parecoxib sodium in a 40-milligram dose for intravenous/intramuscular, or i.v./i.

Single doses of parecoxib sodium intravenously are as effective as ketorolac in reducing pain after oral surgery.

Purpose: Our goal was to compare the analgesic efficacy and safety of single doses of intravenous parecoxib sodium, a prodrug of the novel cyclooxygenase (COX)-2-selective inhibitor valdecoxib, with intravenous ketorolac and placebo in postoperative oral surgery patients.

Patients And Methods: Eligible patients experiencing moderate to severe pain within 6 hours of surgery to extract 2 or more impacted third molars were randomized to receive a single dose of parecoxib sodium 1, 2, 5, 10, 20, 50, or 100 mg; ketorolac 30 mg; or placebo. Analgesic efficacy was assessed over a 24-hour treatment period or until rescue analgesia was required.

Analgesia with ibuprofen arginate versus conventional ibuprofen for patients with dysmenorrhea: a crossover trial.

Background: Dysmenorrhea produces painful abdominal cramps that can disrupt the personal lives and productivity of women.

Objective: The aim of this study was to compare the analgesic efficacy, including onset and duration of pain relief, peak effect, and total effect, and tolerability of ibuprofen arginate with those of conventional ibuprofen in patients with moderate to severe pain associated with primary dysmenorrhea.

Methods: Patients were administered a single dose of ibuprofen arginate (200 or 400 mg), conventional ibuprofen (200 or 400 mg), or placebo during each of 5 menstrual cycles in a single-center, double-blind, randomized, double-dummy, 5-cycle, crossover study.

A controlled comparative study of ibuprofen arginate versus conventional ibuprofen in the treatment of postoperative dental pain.

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.

The efficacy of combination analgesic therapy in relieving dental pain.

Background: An experience of poorly managed pain related to dental treatment can lead patients to avoid or postpone treatment. The development of new pain management strategies equips dental clinicians with additional treatment options that can provide more effective pain relief

Literature Reviewed: The author reviewed dental and medical literature dealing with the safety, efficacy and mechanisms of action of common analgesic treatments.

Conclusions: For the treatment of mild to moderate pain, acetaminophen and non-steroidal anti-inflammatory drugs, or NSAIDs, continue to be the most appropriate options.

Ketoprofen, acetaminophen, and placebo in the treatment of tension headache.

Seven hundred three subjects completed a randomized, double-blind, parallel-group, single-center study comparing the single-dose efficacy of ketoprofen 12.5 mg, ketoprofen 25 mg, acetaminophen 1000 mg, and placebo in the treatment of tension headache. For the primary efficacy variable, 4-hour sum of pain relief intensity differences, ketoprofen 25 mg was significantly superior to placebo.

The optimal analgesic dose of rofecoxib: Overview of six randomized controlled trials.

Background: Rofecoxib, which specifically inhibits cyclooxygenase-2, is indicated for relief of the signs and symptoms of osteoarthritis and for the management of acute pain in adults. The authors present an overview of six placebo-controlled trials designed to evaluate the single-dose analgesic efficacy of a range of doses of rofecoxib in the treatment of postoperative dental pain.

Methods: The six studies included doses of rofecoxib ranging from 7.

Comparison of bromfenac and naproxen sodium in the management of primary dysmenorrhea.

Objective: To compare a new analgesic with an established standard and placebo in the treatment of primary dysmenorrhea.Methods: Bromfenac (B) 25 or 50 mg prn, up to 4 doses daily, was compared with naproxen sodium (N) (550/275 mg) and placebo (P) in a double-blind crossover randomized trial where 54 women were treated over 4 menstrual periods. Each treatment lasted up to 3 days.

Efficacy and tolerability of the specific cyclooxygenase-2 inhibitor DFP compared with naproxen sodium in patients with postoperative dental pain.

DFP [3-(2-propyloxy)-(4-methyl-sulfonylphenyl)-(5,5-dimethyl)-fu ranone] is a highly specific cyclooxygenase-2 inhibitor (>2500-fold selective in transfected Chinese hamster ovary cell assays) that has demonstrated efficacy in preclinical models of pain and inflammation. The present single-dose, randomized, double-masked, double-dummy, placebo-controlled, parallel-group study was undertaken to compare DFP 5, 25, and 50 mg with naproxen sodium 550 mg and with placebo in 196 patients (mean age, 25.8 years; 187 [95.

Characterization of rofecoxib as a cyclooxygenase-2 isoform inhibitor and demonstration of analgesia in the dental pain model.

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, and indomethacin (INN, indometacin) inhibit both the constitutive (COX-1) and inducible (COX-2) isoforms of cyclooxygenase. The induction of COX-2 after inflammatory stimuli has led to the hypothesis that COX-2 inhibition primarily accounts for the therapeutic properties of NSAIDs.

Methods: Chinese hamster ovary (CHO) cell lines that express each COX isoform were used to characterize the in vitro selectivity of rofecoxib.

Double-blind, single-dose comparison of bromfenac sodium, tramadol, and placebo after oral surgery.

This double-blind, parallel-group study was performed at a single site in patients with moderate or severe pain after oral surgery to remove one or more impacted third molars. Patients recorded their pain intensity at baseline and were then assigned to receive a single dose of bromfenac sodium (25 mg or 50 mg), tramadol (100 mg), or placebo, using a randomized double-blind code. At regular intervals for up to 8 hours after study drug administration, pain intensity and pain relief were recorded and were used to derive the efficacy variables, total pain relief (TOTPAR), pain intensity difference (PID), and summed pain intensity difference (SPID).

A crossover comparison of bromfenac sodium, naproxen sodium, and placebo for relief of pain from primary dysmenorrhea.

Single and multiple oral doses of bromfenac sodium (10 or 50 mg) were compared with naproxen sodium (550 mg loading/275 mg repeat doses) for the relief of pain from primary dysmenorrhea in 54 women using a crossover design. Pain intensity and pain relief were assessed over 6 h after the first dose, and global ratings were made at the end of day 1 and on day 2. A single dose of bromfenac 10 or 50 mg was as effective as the loading dose of naproxen sodium (550 mg) in relieving the pain from dysmenorrhea through a 6-h period.

Comparative study of ibuprofen lysine and acetaminophen in patients with postoperative dental pain.

This single-dose, double-blind, parallel-group, single-site study compared ibuprofen lysine 400 mg with acetaminophen 1000 mg and placebo in 240 patients with moderate-to-severe postoperative dental pain. The relative onset of analgesic response, overall analgesic efficacy, duration of effect, and safety were assessed over a 6-hour postdose period. Analgesic efficacy was assessed by patient self-rating of pain intensity, pain relief, time to meaningful pain relief, need for additional analgesic medication, and patient global evaluation.

Comparison of ketorolac and meperidine in patients with postoperative pain--impact on health care utilization.

A double-blind, randomized study was conducted to compare the effects of intramuscular ketorolac tromethamine and meperidine hydrochloride, and subsequent oral pain medication, on health care utilization and postoperative recovery. Following abdominal hysterectomy or cholecystectomy, 210 patients (aged 18 to 70 years; 189 women, 21 men) were randomly assigned to therapy and evaluated for efficacy, safety, nursing care requirements, functional independence, recovery milestones, and quality of life. The patients received 30 mg of ketorolac intramuscularly every 3 to 6 hours as needed, followed by 10 mg of ketorolac every 4 to 6 hours, or 100 mg of meperidine intramuscularly every 3 to 6 hours as needed, followed by acetaminophen/codeine (600 mg/60 mg) orally every 4 to 6 hours.

Histologic evaluation of the bone/graft interface after mandibular augmentation with hydroxylapatite/purified fibrillar collagen composite implants.

Samples of the bone/graft interface were evaluated histologically in five patients 1 year after mandibular ridge augmentation with a composite of hydroxylapatite particles in a matrix of purified fibrillar collagen (HA/PFC). The resulting defects were refilled with HA/PFC after the biopsy specimens were obtained. Histologic examination of the specimens yielded no evidence of purified fibrillar collagen.

A single-dose study of the efficacy and safety of FS 205-397 (250 mg or 500 mg) versus aspirin and placebo in the treatment of postsurgery dental pain.

The efficacy and safety of two dose levels of FS 205-397 (either 250 or 500 mg) were compared with the efficacy and safety of aspirin 650 mg and placebo in a 6-hour, single-dose, double-blind study in 161 patients who had undergone extraction of third molars. Each of the doses of FS 205-397, as well as aspirin, produced analgesia. However, the analgesic effects of both the 500 mg dose of FS 205-397 and aspirin were at times significantly better and more prolonged than those produced by the lower dose of FS 205-397.

Double-blind crossover comparison of ketoprofen, naproxen, and placebo in patients with primary dysmenorrhea.

Sixty-three women, aged 18 to 39 years, with primary dysmenorrhea received 25 mg, 50 mg, or 75 mg of ketoprofen, 500 mg of naproxen, or placebo as a first dose at the onset of moderate or severe pain. Each patient received three treatments and each treatment was tested in 36 patients. Mean pain relief scores (on a five-point scale) indicated a significant analgesic response for all active treatments; superiority over placebo was shown by ketoprofen 50 mg for six hours, by ketoprofen 75 mg for five hours, by ketoprofen 25 mg for four hours, and by naproxen for four hours.

Multicenter clinical trial of ibuprofen and acetaminophen in the treatment of postoperative dental pain.

Pharmacological management of pain for acute and chronic conditions has been guided by a scientific understanding of peripheral and central acting mechanisms for the control of inflammation as well as pain. Oral surgery pain is a reliable model to reference the effectiveness of commonly used analgesics such as ibuprofen and acetaminophen. A total of 706 patients who were experiencing moderate to severe pain received a single dose of ibuprofen, acetaminophen, or placebo.