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Latest Research on Treatment of Dental Pain

Evaluation of ibuprofen/paracetamol for postoperative dental pain PAIN-Volume 152, Issue 3 , Pages 632-642, March 2011.

Subjects with at least 3 impacted third molars and experiencing moderate to severe postoperative pain were randomised to receive: 1 or 2 tablets of a single-tablet combination of ibuprofen 200mg/paracetamol 500mg; 2 tablets of ibuprofen 200 mg/codeine 12.8mg; 2 tablets of paracetamol 500mg/codeine 15mg; or placebo. Results for the primary endpoint, the sum of the mean scores of pain relief combined with pain intensity differences over 12hours, demonstrated that 1 and 2 tablets of the single-tablet combination of ibuprofen/paracetamol were statistically significantly more efficacious than 2 tablets of placebo (P<0.0001) and paracetamol/codeine (P?0.0001); furthermore, 2 tablets offered significantly superior pain relief to ibuprofen/codeine (P=0.0001), and 1 tablet was found noninferior to this combination. Adverse events were uncommon during this study and treatment emergent adverse events were statistically significantly less frequent in the groups taking the ibuprofen/paracetamol combination compared with codeine combinations. In conclusion, 1 or 2 tablets of a single-tablet combination of ibuprofen 200mg/paracetamol 500mg provided highly effective analgesia that was comparable with, or superior to, other combination analgesics currently indicated for strong pain..

Does Dental Pain Improve With Oral Prednisone? Annals of Emergency Medicine, Volume 56, Issue 3, Supplement , Page S141, September 2010

Patients were then asked to rate their pain on a visual analog scale of 1-10 (VAS, with 10 being the worst) at presentation. In the ED, subjects were given either 60 mg of prednisone or a placebo and discharged with acetaminophen/hydrocodone, Pen VK or Clindamycin if penicillin-allergic, and 2 pills of either a placebo or 60 mg prednisone. Patients were called at 24 and 48 hours and again asked to rate their pain The administration of a 3-day burst of prednisone to patients with pulpitis did not result in a statistically significant reduction in pain at either 24 or 48 hours compared to placebo. The administration of prednisone also did not cause a significant reduction in the amount of narcotics taken, or the patients' overall improvement. Therefore, this study suggests that the addition of prednisone to for the treatment of pulpitis does not significantly reduce pain or decrease narcotic use.

Paracetamol for pain relief after surgical removal of lower wisdom teeth. Cochrane Database of Systematic Reviews 2007, Issue 3

Twenty-one trials (with over 2000 participants) were included. Paracetamol provided a statistically significant benefit when compared with placebo for pain relief at both 4 and 6 hours after taking the drug. It is most effective at 1000 mg dose, and can be taken at six hourly intervals without compromising safety. There was no statistically significant difference between the number of patients who reported adverse events, overall this being 19% in the paracetamol group and 16% in the placebo group. It should be noted that most of the studies were found to have some limitations mainly due to poor reporting of information. However the review concludes that paracetamol is a safe, effective drug for the treatment of postoperative pain following the surgical removal of lower wisdom teeth. FULL REVIEW

1. Moller, P.L., et al., Time to onset of analgesia and analgesic efficacy of effervescent acetaminophen 1000 mg compared to tablet acetaminophen 1000 mg in postoperative dental pain: a single-dose, double-blind, randomized, placebo-controlled study [In Process Citation]. J Clin Pharmacol, 2000. 40(4): p. 370-8.

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.

2. Dionne, R., COX-2 inhibitors: better than ibuprofen for dental pain? Compend Contin Educ Dent, 1999. 20(6): p.518-20, 522-4.

3. Doroschak, A.M., W.R. Bowles, and K.M. Hargreaves, Evaluation of the combination of flurbiprofen and tramadol for management of endodontic pain. J Endod, 1999. 25(10): p. 660-3.

Effective management of endodontic pain represents a continuing challenge. In this study, we evaluated the efficacy of flurbiprofen and a novel centrally acting analgesic, tramadol, alone and in combination, for reducing pain in endodontic emergency patients. Patients (n = 49) were administered a local anesthetic and underwent pulpectomy. They were then administered, on a double-blind basis, either: (i) placebo (one capsule to start and then every 6 h); (ii) flurbiprofen (100 mg loading dose and then 50 mg every 6 h); (iii) tramadol (100 mg loading dose and then 100 mg every 6 h); or (iv) the combination of flurbiprofen and tramadol (as above). Pulpectomy combined with placebo medication resulted in a 50% reduction in pain by 24 h (p 0.01). Patients treated with flurbiprofen and tramadol reported less pain, compared with placebo treatment at 6 and 24 h (p 0.01 for both). These results suggest that a nonsteroidal anti-inflammatory drug/opiate combination, together with endodontic therapy, may be useful in the management of endodontic pain.

4. Ehrich, E.W., et al., Characterization of rofecoxib as a cyclooxygenase-2 isoform inhibitor and demonstration of analgesia in the dental pain model. Clin Pharmacol Ther, 1999. 65(3): p. 336-47.

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. Single oral doses of rofecoxib and indomethacin were then assessed in subjects with use of ex vivo COX- isoform specific assays (serum thromboxane B2 [TXB2] and lipopolysaccharide [LPS]-stimulated whole blood prostaglandin E2 and assays of COX-1 and COX-2 activity, respectively). A double-blind, parallel-group study compared the analgesic efficacy of rofecoxib to placebo and ibuprofen in 102 patients with dental pain.
RESULTS: Rofecoxib showed a >800-fold COX-2 selectivity with use of CHO cells that express human COX-1 and COX-2. In subjects, dose- and concentration-dependent inhibition of LPS-stimulated prostaglandin E2 was observed with both rofecoxib (IC50 [the concentration estimated to produce 50% inhibition], 0.77 micromol/L) and indomethacin (IC50, 0.33 micromol/L). Whereas indomethacin inhibited TXB2, (IC50, 0.14 micromol/L), no inhibition was observed with rofecoxib even at doses of up to 1000 mg. In the dental pain study, total pain relief (TOTPAR) over the 6 hours after dosing was similar between 50 mg and 500 mg rofecoxib and 400 mg ibuprofen (P > .20). All active treatments showed greater improvement than placebo (P .001)
CONCLUSIONS: Rofecoxib inhibited COX-2 without evidence of COX-1 inhibition, even at oral doses of up to 1000 mg. Nonetheless, rofecoxib showed analgesic activity indistinguishable from that observed with ibuprofen, a nonisoform-selective COX inhibitor. These results support the hypothesis that the analgesic effects of NSAIDs primarily derive from inhibition of COX-2.

5. Malmstrom, K., et al., Comparison of rofecoxib and celecoxib, two cyclooxygenase-2 inhibitors, in postoperative dental pain: a randomized, placebo- and active- comparator-controlled clinical trial. Clin Ther, 1999. 21(10): p. 1653-63.

Pain is a common complaint, often occurring in conjunction with inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly used analgesic agents in ambulatory patients. In recent studies, the cyclooxygenase-2 (COX-2) inhibitor rofecoxib demonstrated analgesic effects similar to those of NSAIDs in the treatment of acute pain and primary dysmenorrhea. The present randomized, single-dose, double-blind, double-dummy, placebo- and active-comparator-controlled, parallel-group study was undertaken to compare the analgesic efficacy of the COX-2 inhibitors rofecoxib 50 mg and celecoxib 200 mg with that of ibuprofen 400 mg and placebo in patients with postoperative dental pain. Two hundred and seventy-two patients experiencing pain after the removal of > or =2 third molars were randomized according to pain severity (moderate vs severe) to receive a single dose of placebo (n = 45), rofecoxib 50 mg (n = 90), celecoxib 200 mg (n = 91), or ibuprofen 400 mg (n = 46). Using a patient diary, patients recorded pain intensity, pain relief, and global evaluations throughout the 24-hour period after dosing. The overall analgesic effect, onset of action, peak effect, and duration of effect were evaluated, with the primary end point being total pain relief over 8 hours (TOPAR8). The safety profile was assessed on the basis of physical findings, laboratory results, and spontaneous reports of adverse experiences. The results showed that compared with celecoxib, rofecoxib had superior analgesic effects on all measures of analgesic efficacy, including overall analgesic effect (TOPAR8, 18.3 vs. 12.5; P24 vs. 5.1 hours; P0.001). In addition, rofecoxib's analgesic efficacy was similar to that of ibuprofen (TOPAR8, 18.3 vs. 17.0; P = 0.460), but the duration was longer (P0.05); with ibuprofen, the time to on set was 24 minutes, peak pain relief score was 2.9, and duration of analgesic effect was 8.9 hours. The safety profile was similar across all treatment groups. Thus rofecoxib provided analgesic efficacy superior to that of celecoxib and comparable to that of ibuprofen in the treatment of patients with acute postoperative dental pain.

6. Scott, L.J. and H.M. Lamb, Rofecoxib. Drugs, 1999. 58(3): p. 499-505; discussion 506-7.

Rofecoxib selectively inhibits cyclo-oxygenase-2 in a dose-dependent manner in humans. No significant inhibition of cyclo-oxygenase-1 is observed with rofecoxib up to doses of 1000 mg. In 4 large double-blind randomised trials performed in patients with osteoarthritis, rofecoxib 12.5 and 25 mg/day significantly improved physical functioning, assessed using the Western Ontario and McMasters Universities Osteoarthritis Index and patient or investigator global assessment, compared with placebo. In addition, rofecoxib showed similar clinical efficacy to that observed with diclofenac 50 mg 3 times daily, ibuprofen 800 mg 3 times daily and nabumetone 1500 mg once daily. Rofecoxib is also an effective analgesic in patients with primary dysmenorrhoea or postoperative dental pain and demonstrates similar analgesic efficacy to that of naproxen sodium and ibuprofen. Rofecoxib is generally well tolerated. The most common adverse events associated with rofecoxib are diarrhoea, headache, nausea and upper respiratory tract infection. There was a significantly lower incidence of upper- gastrointestinal adverse events (perforations, ulcers and bleeds) in patients with osteoarthritis receiving rofecoxib 12.5, 25 or 50 mg/day than in those receiving ibuprofen, diclofenac or nabumetone.

7. Scolari, G., et al., A comparison of nimesulide beta cyclodextrin and nimesulide in postoperative dental pain. Int J Clin Pract, 1999. 53(5): p. 345-8.

The aim of this study was to assess the efficacy and tolerability of single doses of nimesulide beta cyclodextrin compared with nimesulide in patients with dental pain following surgical procedures. This was a randomised, double-blind, between-patient, multicentre study involving 148 outpatients suffering from moderate to severe pain, who received single doses of either 400 mg nimesulide beta cyclodextrin or 100 mg nimesulide. The principal criterion for efficacy was pain intensity assessed on a visual analogue scale (VAS) 15 minutes after drug intake. Pain intensity was further evaluated 30, 45, 90, 120, 180, 240 and 360 minutes after dosing. Pain relief was evaluated at the same time points by means of a categorical scale. The time point of first pain relief, the use of rescue medication and the global evaluation of efficacy were also recorded. The reduction in pain intensity was significantly more pronounced in the nimesulide beta cyclodextrin group at 15, 30, 45 and 60 minutes (p 0.01). Pain relief was significantly greater (p 0.05) and more rapid with nimesulide beta cyclodextrin. In the patient overall assessment of efficacy, nimesulide beta cyclodextrin and nimesulide were rated excellent or good by 95% and 92% respectively; only one patient in the nimesulide beta cyclodextrin group needed rescue medication. Both study drugs were effective and well tolerated in the treatment of acute dental pain, with nimesulide beta cyclodextrin showing a faster onset of analgesic action.

8. Moore, P.A., Pain management in dental practice: tramadol vs. codeine combinations. J Am Dent Assoc, 1999. 130(7): p. 1075-9.

BACKGROUND: Tramadol hydrochloride is a novel, centrally acting analgesic with two complementary mechanisms of action: opioid and aminergic. First marketed in 1994, tramadol is frequently prescribed by physicians for the management of moderate-to-moderately severe chronic pain. The author evaluates its unique analgesic pharmacology and limited clinical utility for managing acute pain in dentistry. TYPES OF STUDIES REVIEWED: Clinical drug trials in medicine and dentistry were reviewed to assess analgesic efficacy. Postmarketing surveillance studies and reports of adverse drug events were evaluated to determine short- and long-term safety.
RESULTS: Tramadol's maximum analgesic efficacy for relieving acute pain after oral surgery appears to be similar to that of 60 milligrams of codeine alone but less than that of a full therapeutic dose of a nonsteroidal anti-inflammatory drug or a codeine combination, such as aspirin/codeine or acetaminophen/codeine. Adverse events reported by patients receiving tramadol therapy since it was approved by the Food and Drug Administration suggest a risk of seizures, drug abuse and anaphylactoid reactions. CLINICAL IMPLICATIONS: Tramadol has limited indication for management of acute pain in dentistry, possibly as an alternative analgesic when gastrointestinal side effects contraindicate the use of nonsteroidal anti-inflammatory drugs and when codeine/acetaminophen combination analgesics are not well-tolerated or are contraindicated.

9. Bagan, J.V., et al., Clinical comparison of dexketoprofen trometamol and dipyrone in postoperative dental pain. J Clin Pharmacol, 1998. 38(12 Suppl): p. 55S-64S.

A total of 125 outpatients with moderate to severe pain after surgical removal of one impacted third molar were randomly assigned to receive dexketoprofen trometamol 12.5 or 25 mg or dipyrone 575 mg. For first- dose assessments, patients rated their pain intensity and its relief at regular intervals. From 60 min post dose to the end of the 6-h observation period, both doses of dexketoprofen trometamol had higher pain relief scores than dipyrone: Between 3 and 6 h the differences were statistically significant. In addition, peak measures (PIDmax and PARmax) were statistically superior after both doses of dexketoprofen trometamol compared to dipyrone. The overall efficacy assessed at the end of the first-dose phase was rated as good or excellent by 90%, 83.3%, and 70% of patients receiving dexketoprofen trometamol 25 mg, dexketoprofen trometamol 12.5 mg, and dipyrone, respectively. The number of patients who required remedication during the 6-h period was significantly lower in both dexketoprofen groups. Repeated-dose data were also obtained. No significant differences were found in the efficacy after repeated doses, the number of doses taken, or the mean time elapsed between doses. The overall efficacy at the end of the repeated-dose phase was rated as good or excellent by 84.2%, 66.7%, and 70% of patients receiving dexketoprofen trometamol 25 mg, dexketoprofen trometamol 12.5 mg, and dipyrone, respectively. The frequency of adverse events was similar for all treatments and no serious adverse events were reported during the study.

10.    Anderson, K., Painless dentistry. Fact or fiction? CDS Rev, 1998. 91(5): p. 14-21.


11.    Mamiya, H., et al., Pain following intravenous administration of sedative agents: a comparison of propofol with three benzodiazepines. Anesth Prog, 1998. 45(1): p. 18-21.

The purpose of the present study is to compare the injection pain of propofol with that of benzodiazepines when used for intravenous sedation. In addition, we evaluated the efficacy of coadministering a small dose of 1% lidocaine (20 mg) to reduce the pain accompanying propofol injection. Intravenous propofol, diazepam, midazolam, or flunitrazepam were administered on separate occasions to volunteers and outpatients. The degree of injection pain was evaluated by the Visual Analog Scale (VAS) ruler. The efficacy of premixed lidocaine with propofol was also compared among the patients. The venous pain of propofol was significantly more intense than that of the three other drugs (P 0.05). The injection pain of diazepam was more intense than that of midazolam (P 0.05). Many patients reported no pain when propofol was coadministered with lidocaine. The addition of a small dose (20 mg) of lidocaine reduced the VAS pain score to comparable levels observed for benzodiazepines. Because injection pain might affect the patients' comfort during sedation, the addition of lidocaine to the propofol injection is deemed useful for intravenous sedation.

12.       Singer, E. and R. Dionne, A controlled evaluation of ibuprofen and diazepam for chronic orofacial muscle pain. J Orofac Pain, 1997. 11(2): p. 139-46.

The clinical efficacy, side effect liability, and hormonal effects of two prototypic pharmacologic agents were evaluated for the management of chronic myogenous facial pain in a double-blind, randomized, controlled clinical trial. Thirty-nine subjects (35 women,. 4 men) with daily or near-daily orofacial pain of at least 3 months' duration and tenderness to palpation of masticatory muscles participated. Patients were randomly allocated to one of four treatments: placebo, diazepam, ibuprofen, or the combination of diazepam and ibuprofen. Pain, mood, muscle tenderness, maximal interincisal opening, and plasma levels of beta-endorphin were measured following 2-week baseline and 4-week treatment periods. Pain, as measured by a visual analog scale, was significantly decreased in the diazepam and diazepam plus ibuprofen groups but not for the ibuprofen or placebo groups. Analysis of variance showed a significant drug effect for diazepam but not for ibuprofen, indicating that pain relief was attributable to diazepam. No significant changes were noted in muscle tenderness, interincisal opening, or plasma beta-endorphin level. This study supports the efficacy of diazepam in the short-term management of chronic orofacial muscle pain. The lack of effect following administration of an anti- inflammatory analgesic suggests that inflammation is not the basis for chronic muscle pain in the orofacial region, and that the analgesic effect of such medications is not sufficient for pain relief in this condition.

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