第三大臼歯手術における局所トラマドール併用先制経口ケトロラクと経口ケトロラクの比較。比較臨床試験（A Comparative Clinical Trial

Preemptive Oral Ketorolac with Local Tramadol Versus Oral Ketorolac in Third Molar Surgery: A Comparative Clinical Trial.

抄録

目的:

下顎骨第三大臼歯の手術において、プラセボ含有ケトロラク内服薬とトラマドール含有ケトロラク内服薬の先制鎮痛効果を比較検討すること。

Aims: To assess preemptive analgesic efficacy of oral ketorolac with submucous placebo versus oral ketorolac with submucous tramadol during impacted mandibular third molar surgery.

方法論:

両側下顎骨第三大臼歯嵌頓の患者40名を対象とした二重盲検比較臨床試験を実施した。40名の患者をA群とB群に分け、A群にはケトロラクと粘膜下トラマドールを、B群にはケトロラクと粘膜下プラセボを経口投与した。試験項目は、疼痛強度スコア、1回目の救援鎮痛薬の服用時間、術後24時間以内の鎮痛薬摂取の必要性、患者の経験であった。

Methodology: A double-blind, split-mouth clinical study was carried on 40 patients having bilateral impacted mandibular third molars. They were divided as group A comprising of 40 patients in whom oral ketorolac with submucous tramadol was administered and group B comprising of 40 patients in whom oral ketorolac with submucous placebo was administered. The study parameters included were pain intensity scores, duration to take 1st rescue analgesia, need of analgesic intake during the first 24 h postoperatively and patient's experience.

結果:

平均疼痛強度スコア（VRS、VAS）、術後鎮痛薬の必要性、薬剤関連合併症の評価において、患者の経験はB群に比べA群で良好であった。

Results: The patient's experience was found to be better in the group A as compared to group B while evaluating mean pain intensity scores (VRS, VAS); need of postoperative analgesics and drug-related complications.

結論:

Conclusion: Preemptive oral ketorolac with tramadol in comparison to oral ketorolac results in better pain relief, longer pain free intervals with minimum rescue analgesics requirement & lesser postoperative analgesics consumption.