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The postoperative analgesic efficacy and safety of piroxicam (FDDF) and naproxen sodium.
Int J Clin Pharmacol Res. 1998; 18(1):21-9.IJ

Abstract

The aim of the present study was to compare the analgesic efficacy of piroxicam-FDDF (fast dissolving dosage form) with naproxen sodium, following bilateral removal of impacted third molars. A double-blind, randomized, crossover, analgesic trial was carried out on 40 patients undergoing surgical removal of one lower third molar at each visit. The analgesic efficacy of a single dose regimen of piroxicam-FDDF (40 mg, Feldene Flash, Pfizer, Turkey) was compared with naproxen sodium (550 mg, Anaprotab, Sanli, Turkey). Pain intensity was measured on a category-rating scale during the 8-h period after drug administration. Each patient evaluated the efficacy of the study medication at 15, 30, 45, 60, 90 and 120 min, and then hourly for up to 8 h of drug ingestion. Additional key efficacy measures were also determined (pain intensity difference [PID], sums of pain intensity difference [SPID], total pain relief [TOTPAR], peak pain relief, number of observations at which pain was half-relieved, overall evaluation of study medication effectiveness, and time to medication with a back-up analgesic). The data were analyzed by paired Student's t-test and one-way analysis of variance (ANOVA). Results are expressed as means +/- SEM, and p < 0.05 was taken as statistically significant. The PID and pain relief scores of the piroxicam-FDDF group were significantly greater than those for the naproxen sodium group at 15, 30, 45 and 60 min (p < 0.01). After 90 min to 8 h, no statistical significance was revealed among the two test groups (p > 0.05). The peak pain relief, maximal analgesic effect, SPID, TOTPAR values, adjusted mean number of observations with pain at least half-relieved, and the final overall evaluation records were all superior for piroxicam-FDDF (p < 0.05). The results of this study clearly show that the analgesic efficacy of piroxicam-FDDF is superior to naproxen sodium in the treatment of pain following oral surgery for the removal of impacted third molars.

Authors+Show Affiliations

Selçuk E
Ege University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Izmir, Turkey.
Gomel M
No affiliation info available
Apaydin S
No affiliation info available
Köse T
No affiliation info available
Tuglular I
No affiliation info available

MeSH

AdolescentAdultAnalgesicsAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodFemaleHumansMaleNaproxenPain MeasurementPain, PostoperativePiroxicamTooth Extraction

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

9604731

Citation

Selçuk, E, et al. "The Postoperative Analgesic Efficacy and Safety of Piroxicam (FDDF) and Naproxen Sodium." International Journal of Clinical Pharmacology Research, vol. 18, no. 1, 1998, pp. 21-9.
Selçuk E, Gomel M, Apaydin S, et al. The postoperative analgesic efficacy and safety of piroxicam (FDDF) and naproxen sodium. Int J Clin Pharmacol Res. 1998;18(1):21-9.
Selçuk, E., Gomel, M., Apaydin, S., Köse, T., & Tuglular, I. (1998). The postoperative analgesic efficacy and safety of piroxicam (FDDF) and naproxen sodium. International Journal of Clinical Pharmacology Research, 18(1), 21-9.
Selçuk E, et al. The Postoperative Analgesic Efficacy and Safety of Piroxicam (FDDF) and Naproxen Sodium. Int J Clin Pharmacol Res. 1998;18(1):21-9. PubMed PMID: 9604731.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The postoperative analgesic efficacy and safety of piroxicam (FDDF) and naproxen sodium. AU - Selçuk,E, AU - Gomel,M, AU - Apaydin,S, AU - Köse,T, AU - Tuglular,I, PY - 1998/5/30/pubmed PY - 1998/5/30/medline PY - 1998/5/30/entrez SP - 21 EP - 9 JF - International journal of clinical pharmacology research JO - Int J Clin Pharmacol Res VL - 18 IS - 1 N2 - The aim of the present study was to compare the analgesic efficacy of piroxicam-FDDF (fast dissolving dosage form) with naproxen sodium, following bilateral removal of impacted third molars. A double-blind, randomized, crossover, analgesic trial was carried out on 40 patients undergoing surgical removal of one lower third molar at each visit. The analgesic efficacy of a single dose regimen of piroxicam-FDDF (40 mg, Feldene Flash, Pfizer, Turkey) was compared with naproxen sodium (550 mg, Anaprotab, Sanli, Turkey). Pain intensity was measured on a category-rating scale during the 8-h period after drug administration. Each patient evaluated the efficacy of the study medication at 15, 30, 45, 60, 90 and 120 min, and then hourly for up to 8 h of drug ingestion. Additional key efficacy measures were also determined (pain intensity difference [PID], sums of pain intensity difference [SPID], total pain relief [TOTPAR], peak pain relief, number of observations at which pain was half-relieved, overall evaluation of study medication effectiveness, and time to medication with a back-up analgesic). The data were analyzed by paired Student's t-test and one-way analysis of variance (ANOVA). Results are expressed as means +/- SEM, and p < 0.05 was taken as statistically significant. The PID and pain relief scores of the piroxicam-FDDF group were significantly greater than those for the naproxen sodium group at 15, 30, 45 and 60 min (p < 0.01). After 90 min to 8 h, no statistical significance was revealed among the two test groups (p > 0.05). The peak pain relief, maximal analgesic effect, SPID, TOTPAR values, adjusted mean number of observations with pain at least half-relieved, and the final overall evaluation records were all superior for piroxicam-FDDF (p < 0.05). The results of this study clearly show that the analgesic efficacy of piroxicam-FDDF is superior to naproxen sodium in the treatment of pain following oral surgery for the removal of impacted third molars. SN - 0251-1649 UR - https://www.unboundmedicine.com/medline/citation/9604731/The_postoperative_analgesic_efficacy_and_safety_of_piroxicam__FDDF__and_naproxen_sodium_ DB - PRIME DP - Unbound Medicine ER -