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A randomised, single-blind, within-patient, crossover study was done in 45 patients (29 women and 16 men, mean age 49 years, range 37-71) who had bilateral "identical" gingivectomies. On one occasion a standard volume of local anaesthetic containing 2% lidocaine and 1/80,000 adrenaline was infiltrated into the mucosal tissue before operation. On the other, double the standard volume with 1% lidocaine and 1/160,000 adrenaline was infiltrated. The intensity of postoperative pain was recorded by the patients on a 100 mm visual analogue scale every hour for an 11-hour observation period. The time courses and the sum of pain intensity after injection of the double and standard volumes did not differ significantly. Doubling the volume of local anaesthetic while maintaining the total lidocaine and adrenaline concentration that was infiltrated does not influence the intensity of acute pain after gingivectomy.

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BACKGROUND: The purpose of this randomized double-blind study was to compare the efficacy and safety of propacetamol 2 g (an i.v. acetaminophen 1 g formulation) administered as a 2-min bolus injection (n=50) or a 15-min infusion (n=50) with oral acetaminophen 1 g (n=50) or placebo (n=25) for analgesia after third molar surgery in patients with moderate to severe pain after impacted third molar removal. METHODS: All patients were evaluated for efficacy during the initial 6 h period after treatment administration (T(0)) and for safety during the entire week after T(0). RESULTS: The onset of analgesia after propacetamol was shorter (3 min for bolus administration, 5 min for 15-min infusion) than after oral acetaminophen (11 min). Active treatments were significantly better for all parameters (pain relief, pain intensity, patient's global evaluation, duration of analgesia) than placebo (P<0.05). Adverse events were more frequent after propacetamol, especially pain at the injection site. Propacetamol bolus resulted in a much higher incidence of local adverse events than the infusion (propacetamol bolus 90% vs propacetamol infusion 52%) with no clinically significant benefits in terms of analgesic efficacy. CONCLUSION: I.V. propacetamol, administered as a 15-min infusion, is a fast-acting analgesic agent. It is more effective in terms of onset of analgesia than a similar dose of oral acetaminophen.

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A controlled, randomized, double-blind crossover study, in which the patients acted as their own controls, was carried out to test the efficacy of naproxen 500 mg x 2 versus acetaminophen 1000 mg x 4 for 3 days on the postoperative course following third molar surgery. Acetaminophen reduced the mean swelling on the 3rd postoperative day by 22.4% (p = 0.023) compared to that after naproxen. On the 6th postoperative day, there was 20.9% less mean swelling with naproxen (p = 0.44), although the total swelling measurements were much less than those measured on the 3rd postoperative day. Summed pain intensity (SUMPI3.5-11) on the day of surgery revealed no statistically significant difference between the acetaminophen or naproxen regimen with the exception of 0.5 hours (p = 0.002) and 1 hour (p = 0.009) after first medication when acetaminophen gave less pain than naproxen. Since the drug regimens were different, summed PI for the first acetaminophen dose interval (SUMPI3.5-6) and the first naproxen dose interval (SUMPI3.5-9) was calculated. There was a tendency toward a statistically significant difference in favor of acetaminophen for SUMPI3.5-6 (p = 0.055) but no statistically significant difference (p = 0.41) between the treatments with respect to SUMPI3.5-9. Naproxen was statistically superior (p < or = 0.002) to acetaminophen at 08:00, 12:00, and 16:00 hours on the 1st postoperative day and at 08:00 hours on the 2nd postoperative day, when the pain intensity level was lower than that on the day of surgery. A 3-day acetaminophen regimen reduces acute postoperative swelling better than naproxen on the 3rd postoperative day after third molar surgery but not on the 6th postoperative day when the total swelling is less.

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AIMS: To evaluate the effect of a 3-day regimen of ibuprofen 600 mg x 4 on acute postoperative swelling and pain and other inflammatory events after third molar surgery compared with a traditional regimen of paracetamol 1000 mg x 4. METHODS: A controlled, randomized, double-blind, cross-over study where 36 patients (26 females, 10 males) with mean age 23 (range 19-27) years acted as their own controls. All patients were subjected to surgical removal of bilateral third molars. After one operation the patients received tablets of ibuprofen 600 mg x 4 for 3 days. After the other operation they received an identical regimen of paracetamol 1000 mg tablets. Swelling was objectively measured (mm) with a standardized face bow and the patients scored their pain intensity (PI) on a 100-mm visual analogue scale. RESULTS: There was no statistically significant difference between paracetamol and ibuprofen treatment with respect to effect on acute postoperative swelling. Swelling after paracetamol on the third postoperative day was 1.8% less than that after ibuprofen. Mean (95% CI) difference between treatments was -0.3 (-4.7, 4.1) mm. On the sixth postoperative day swelling after ibuprofen was 2.3% less than that after paracetamol. Mean (95% CI) between treatments was 0.2 (-2.4, 2.8) mm. There was no statistically significant difference in pain intensity between the paracetamol and the ibuprofen regimen on the day of surgery. The mean (95% CI) difference between the treatments for summed pain intensity on the day of surgery (SUMPI 3.5-11) was 3.31 (-47.7, 54.3) mm. Two patients developed fibrinolysis of the blood clot (dry socket) after receiving ibuprofen while none did this after paracetamol treatment. There was no noticeable difference between treatments with respect to appearance of haematomas/ecchymoses or adverse effects which all were classified as mild to moderate. CONCLUSIONS: A 3-day regimen of ibuprofen 600 mg x 4 daily does not offer any clinical advantages compared with a traditional paracetamol regimen 1000 mg x 4 daily with respect to alleviation of acute postoperative swelling and pain after third molar surgery.

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A randomized, double-blind, within-patient, crossover study was carried out after bilateral "identical" surgical procedures using local anesthesia only. A 3-day tablet regime of racemic ketoprofen 75 mg or acetaminophen 1000 mg qid (x 4) was given starting 3 hours after surgery. Ketoprofen reduced objectively measured swelling 27.8% (p < 0.04) better than acetaminophen 3 days after surgery and 70.8% (p < 0.02) better than acetaminophen 6 days after surgery. The pain intensity (PI) was lower after ketoprofen than after acetaminophen from 2 to 6 hours after the first drug intake (all p-values < or = 0.03). Sum PI during the first (SUMPI3.5-6, p = 0.003) and second dose intervals (SUMPI6.5-9, p = 0.007) was lower for ketoprofen than for acetaminophen but not different for the third dose interval (SUMPI9.5-11, p = 0.53). Ketoprofen was a more effective analgesic than acetaminophen on the day of surgery (SUMPI3.5-11, p = 0.005). There was no difference (p > 0.05) between the treatments with respect to mouth opening, drug preference, global evaluation, or adverse reports. Adverse reports included stomach pain and diarrhea in both treatment groups. Ketoprofen 75 mg x 4 for 3 days reduces subjectively assessed pain and objectively measured swelling (i.e., anti-inflammatory effect) following third-molar surgery.

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A model using volumetry to evaluate the effect of drugs on acute postoperative swelling after operations for primary Dupuytren's contracture (DC) and carpal tunnel syndrome (CTS) was established and validated. The temperature of the saline and time of measurement during the day influenced the volumetric readings. The error of measurement after volumetry of unoperated and operated hands after operations for DC was 0.7% and 0.6%, respectively. Naproxen (500 mg twice a day), paracetamol (1000 mg four times a day), or placebo were given postoperatively for three days to 35 patients after DC and 42 patients after CTS in a randomised, placebo-controlled study. Hand volume was measured preoperatively and 72 hours after surgery. There was a difference in swelling (p = 0.009) indicating different degree of development of swelling 72 hours postoperatively between the DC and CTS placebo groups, which invalidated pooling of the data. After operations for DC naproxen was slightly but not significantly superior to paracetamol and placebo, with paracetamol numerically superior to placebo. The power of the study, caused by the limited number of patients included, does not permit this difference to reach significance. Operations for CTS caused so little swelling that comparisons were invalidated. Naproxen treatment, irrespective of type of operation, did not require rescue analgesics, while two patients after CTS treated with paracetamol did. Two and six placebo-treated patients required rescue drugs after operations for DC and CTS, respectively. We conclude that naproxen might have a clinical relevant effect on swelling when used on minor surgery in the hand, unlike paracetamol. Naproxen might be a useful analgesic during the immediate postoperative phase.

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AIMS: The combination of lignocaine and adrenaline may cause more postoperative pain than other types of local anaesthetic agents with comparable clinical efficacy. This study investigates the dose-response effect of adrenaline added to lignocaine on postoperative pain, when used as local anaesthetic for oral soft tissue surgery. METHODS: A controlled, randomized, double-blind, parallel group study included 195 patients (108 females/87 males) with mean age 49 years (range 26-75 years). The patients were allocated to one of three treatment groups receiving lignocaine 2% (n = 66), lignocaine 2% with adrenaline 1 : 160 000 (n = 63) or lignocaine 2% with adrenaline 1 : 80 000 (n = 66). RESULTS: Lignocaine 2% with adrenaline 1 : 80 000 gave significantly more pain intensity than lignocaine 2% or lignocaine 2% with adrenaline 1 : 160 000. The postoperative pain intensity courses after lignocaine 2% and lignocaine 2% with adrenaline 1 : 160 000 showed a similar pattern except for the time period just after completion of surgery when lignocaine 2% with adrenaline 1 : 80 000 caused less pain. CONCLUSIONS: High adrenaline concentrations (1 : 80 000) combined with lignocaine local anaesthetic solution offers no advantage with respect to pain alleviation during the immediate postoperative pain period. High exogenous adrenaline concentrations may play a significant role in enhancing acute postoperative intensity.

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A randomized, single-blind, within-patient, crossover study was done in 44 patients (27 women and 17 men mean age 47 years, range 29-63) who had bilateral 'identical' gingivectomies. On one occasion a standard volume of local anaesthetic containing lignocaine 2% and adrenaline (1/80 000) was infiltrated into the mucosal tissue before operation. On the other occasion double the standard volume was infiltrated. The intensity of pain postoperatively was recorded by the patients on 100 mm visual analogue scale every hour for an 11-hour observation period. The intensity of pain when double volume had been given was significantly higher than that after the standard volume from 2 to 8 hours postoperatively (P < 0.04), the median (range) being 52.0 mm (0.0-434.0) compared with 30.5 mm (0.0-359.0) after the standard volume (P < 0.005). Doubling the volume of local anaesthetic containing adrenaline that was infiltrated increased the intensity of acute pain after gingivectomy.

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This randomized, double-blind, placebo-controlled study compared the time to onset of analgesia and the analgesic efficacy of two formulations of acetaminophen 1000 mg--an effervescent solution and tablet--in 242 patients with moderate or severe pain following dental surgery. Onset of analgesia was determined using a two-stopwatch procedure. Analgesia was assessed over a 4-hour period. Treatments were compared using standard indexes of pain intensity and pain relief and summary measures. Both acetaminophen formulations were significantly more effective than their corresponding placebo for all efficacy assessments. The median time to onset of analgesia was significantly shorter with effervescent acetaminophen (20 minutes) compared to tablet acetaminophen (45 minutes). During the first 45 minutes after administration, effervescent acetaminophen was significantly more effective at each scheduled assessment time than tablet acetaminophen. The median time to meaningful pain relief was significantly shorter with effervescent acetaminophen (45 minutes) compared to tablet acetaminophen (60 minutes). At 4 hours after administration, the pain relief was significantly better with tablet acetaminophen than with effervescent acetaminophen. No other significant differences were observed between the active treatments. In conclusion, effervescent acetaminophen produces a significantly faster onset of analgesia than tablet acetaminophen.

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It is known that some local anesthetics may cause pain when the initial local anesthetic effect disappears. The aim of this trial was to compare the postoperative pain intensities after infiltration of plain lidocaine 1% and 2% used in gingivectomies. The trial was done as a controlled, randomized, double-blind, parallel group study involving 117 patients with mean age 48 years (range 29-71 years) allocated to two treatment groups. There was no statistically significant difference between the mean postoperative pain courses of lidocaine 1% and 2% after gingivectomies during an 11-h observation period. A numerical difference was seen from 7 to 11 h in favor of lidocaine 1%. There were more patients experiencing no pain, but more patients reporting higher pain scores in the lidocaine 2% group than in the lidocaine 1% group. These differences were not statistically significant. It can be concluded that there is apparently no difference between lidocaine 1% and 2% with respect to postoperative pain experience when using gingivectomy as a pain model.

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A controlled, randomized, double-blind, within-patient, crossover study was made with 50 patients (28 women and 22 men) of mean age 47 years (range, 32-69 years) who were subjected to identical bilateral gingivectomies. On one occasion, lidocaine 2% was infiltrated as the local anesthetic. On the other occasion, lidocaine 2% with epinephrine 1:80,000 was given. Postoperative pain intensity was recorded by the patients on a 100-mm visual analogue scale every hour during an 11-hour observation period. The mean pain intensity was numerically higher after lidocaine 2% at 0 hours and 1 hour postoperatively. Then the mean pain intensity after lidocaine 2% was lower than that after lidocaine 2% with epinephrine 1:80,000 throughout the remaining observation period. The difference in pain intensity was statistically significant (P < .05) at 2, 4, 5, 6, and 7 hours after surgery. Mean sum (SEM) pain intensity over the 11-hour observation period was lower (P = .03) after lidocaine 2%, 66.5 (13.4) mm than after lidocaine 2% with epinephrine 1:80,000, 92.6 (15.4) mm. The study shows that high epinephrine concentration (1:80,000) increases the postoperative pain after dental soft tissue surgery with mild pain.

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The purpose of this single-dose, randomized, placebo-controlled, and double-blind study was to evaluate the analgesic dose-response relationship of 50-mg, 100-mg, 200-mg, and 400-mg doses of ibuprofen after third molar surgery. Patients were instructed to take a single dose of either placebo or 50 mg, 100 mg, 200 mg, or 400 mg of ibuprofen when the postoperative pain was moderate to severe. Acetaminophen 500 mg was used as a rescue medication. Pain intensity, pain relief, and any possible adverse events were recorded on self-administered questionnaires hourly for 6 hours after intake of study medication. If rescue medication was taken, the time of intake was registered. A total of 304 patients entered the study, and 258 complied with the protocol. A positive analgesic dose-response relationship of 50-mg, 100-mg, 200-mg, and 400-mg doses of ibuprofen was observed when evaluated by pain intensity difference, sum of pain intensity difference, pain relief, total pain relief, and survival distribution of patients not taking rescue medication. Although significant pain relief was seen after a dose of 50 mg ibuprofen, ibuprofen 400 mg provided maximum pain relief and the longest duration of analgesic effect. Mild transient adverse events were reported by 6.8% of the patients. However, there was no significant difference in frequency between the placebo and 50 mg, 100 mg, 200 mg, and 400 mg ibuprofen dose groups.

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Contrary results have been reported from studies comparing horizontal and vertical orientations of the visual analogue scale (VAS) in non-dental pain states. The vertical orientation of the VAS has been used in our department for several years while the horizontal orientation is the most commonly used in other acute pain models. The present study investigated whether a horizontally oriented VAS is as sensitive as a vertically oriented VAS in the assessment of present pain after oral surgery. Seventy-four patients recorded their pain intensity hourly and half-hourly 15 times during 11 hours after surgery on a horizontal and on a vertical 100 mm VAS. Slightly lower mean and median values were observed at 2/3 of the observation time points for the vertical VAS compared to the horizontal VAS. The results from the two scales were compared with analysis of variance for repeated measures. No significant differences between the horizontal and the vertical VAS-values were found (p = 0.099). Distributions (Kolmogorov-Smirnov test) and dispersions of data were also similar with the two orientations of the VAS. This study shows that a vertically oriented VAS is equally sensitive as a horizontally oriented VAS in assessing present pain intensity after oral surgery.

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The acute postoperative courses after bilateral ¿identical¿ surgical removals of symmetrically impacted third molars on two separate occasions were investigated in a study containing two separate trials. Both trials were conducted as open interpatient crossover trials. Codeine phosphate (50 mg), with assumed analgesic effect but with no known clinical antiinflammatory effect, was given 4 times daily for 3 days starting 2 h after surgery in one trial using 20 patients (mean age 22.7 years, 12 females/8 males) and starting 3 h after surgery in the other trial using 20 patients (mean age 23.0 years, 11 females/9 males). Identical surgical procedures were carried out by the same surgeon in the same patient. The study shows the mean postoperative time courses of pain intensity, sum pain intensity, and swelling to be similar after bilateral operations. Pain intensity difference scores as measures of analgesia suggested the influence of carryover effects with respect to the second operation, irrespective of drug starting time. Mouth opening ability was not similar on each occasion after bilateral surgery. It can be concluded that the carryover design in bilateral surgery is valid and useful with respect to testing drug effects on swelling. The bilateral third molar model also offers the ability to test clinically relevant multiple dose regimens in phase 3 trials. It should, however, be recognized that the bilateral third molar model is highly dependent on the skill of the surgeon and may thus be more difficult to complete than parallel group trials.

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1. Single doses of paracetamol 400 (PAR 400) and 800 mg/kg (PAR 800), SUR 2647 combination (free paracetamol + paracetamol-N-acetyl-DL-methionate, paracetamol/methionine ratio 2:1) equivalent to PAR 400 (SURc 400) and PAR 800 (SURc 800) were given p.o. to male Bom:NMRI mice. 2. The objective was to compare the plasma concentrations of free paracetamol and the major metabolites paracetamol-sulphate and paracetamol-glucuronide for a 6 hr period after each test drug. 3. There was no significant difference between PAR 400 and SURc 400 with respect to plasma paracetamol, paracetamol-glucuronide and paracetamol-sulphate concentration with the exception of lower plasma paracetamol concentration (P less than 0.03) at 3 hr following PAR 400. 4. There was no significant difference between PAR 800 and SURc 800 with respect to plasma paracetamol, paracetamol-glucuronide and paracetamol-sulphate concentrations with the exception of lower plasma paracetamol-glucuronide concentration (P less than 0.03) at 4 hr after dosing following SURc 800. 5. Combining free paracetamol and its methionine ester does not seem to alter the pattern of plasma paracetamol, paracetamol-glucuronide and paracetamol-sulphate compared to equal doses of free paracetamol alone after p.o. administration of toxic doses to male Bom:NMRI mice.

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Bacterial endocarditis is a serious condition with high lethality. The authors review the etiology of the disease and conditions and procedures associated with increased risk, and give recommendations on choice and dosage of effective antibiotics. Most cases of endocarditis are caused by gram-positive cocci of the genera Streptococcus, Enterococcus or Staphylococcus. The number of cases caused by staphylococci has increased in recent decades. Risk of acquiring endocarditis is higher, for example, in patients with prosthetic cardiac valves and in patients with a previous history of endocarditis. Interventions associated with increased risk include various procedures in the mouth, throat and upper airways, since this is where the bacteria most often causing endocarditis are to be found. A single oral dose of amoxycillin is recommended for standard prophylaxis, and ampicillin in combination with an aminoglycoside for parenteral use. In cases of penicillin allergy, a single oral dose of clindamycin is recommended in patients at risk of bacteriemia from the respiratory tract, with trimetoprim as an alternative for genito-urinary and gastrointestinal procedures. Vancomycin or vancomycin plus aminoglycoside is recommended as a parenteral regimen in cases of penicillin allergy.

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A new method of producing ischemic tourniquet pain is presented. The present test model showed a sex difference in the pain recordings. Sum pain intensity (SPI) for a 5 min trial period of ischemic pain was lower for males than for females (p less than 0.0001). The observed variability between male test subjects was greater than between female subjects, while the variation in pain scores within subjects was lower for males compared to females. The differences between sexes as a group with respect to variability of pain recordings were not statistically significant. Due to the observed sex differences in pain recording it is recommended to use test subjects of the same sex when restricting the test procedure to a limited number of subjects. The present version of the tourniquet pain test, used according to the recommended criteria, allows discriminating between i.v. administered placebo, opioid analgesics (pethidine) and ketamine.

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