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大学・研究所にある論文を検索できる 「Efficacy of Ibuprofen Gargle for Postoperative Pain After Mandibular Third Molar Extraction: Protocol for a Phase II, Placebo-Controlled, Double-Blind, Randomized Crossover Trial」の論文概要。リケラボ論文検索は、全国の大学リポジトリにある学位論文・教授論文を一括検索できる論文検索サービスです。
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Efficacy of Ibuprofen Gargle for Postoperative Pain After Mandibular Third Molar Extraction: Protocol for a Phase II, Placebo-Controlled, Double-Blind, Randomized Crossover Trial

Kakei, Yasumasa Ioroi, Takeshi Ito, Takahiro Okazaki, Yutaro Hasegawa, Takumi Yano, Ikuko Akashi, Masaya 神戸大学

2022.05

概要

Background: Extraction of mandibular third molars is one of the most commonly performed oral surgical procedures, and nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain management. Oral NSAIDs are associated with adverse events such as gastrointestinal disorders, renal and hepatic dysfunction, and platelet dysfunction. Topical analgesics have been proposed as alternatives to oral and injectable medications to safely improve postoperative pain relief. We will conduct a single-center, placebo-controlled, double-blind, randomized crossover trial to assess the pain-relieving effect of an ibuprofen-containing gargle in patients undergoing extraction of mandibular third molars when compared with a placebo gargle. Objective: This will be the first clinical study to compare the efficacy of an ibuprofen gargle with that of a placebo for relieving postoperative pain in addition to loxoprofen after mandibular third molar extraction. Methods: This study will be performed at Kobe University Hospital. Participants (N=40) will be randomized equally to 1 of 2 groups. The ibuprofen-placebo group will receive an ibuprofen gargle on postoperative day (POD) 1 and a placebo gargle on POD 2. The placebo-ibuprofen group will receive a placebo gargle on POD 1 and an ibuprofen gargle on POD 2. Both groups will receive ibuprofen gargles on PODs 3-5 at least once daily. The primary objective is to estimate the within-subject difference on a visual analog scale (VAS) before and 5 minutes after using the ibuprofen or placebo gargle on PODs 1 and 2. The secondary objectives are to estimate the within-subject differences in ΔVAS before and 15 minutes after using the ibuprofen or placebo gargle on PODs 1 and 2, ΔVAS before and 5 or 15 minutes after using the ibuprofen gargle on PODs 3-5, overall efficacy (self-completion, 5 scales) on PODs 1-5, daily frequency of use (ibuprofen or placebo gargle and analgesics) on PODs 1-7, and the occurrence of adverse events. Results: The Certified Review Board of Kobe University approved the study. The intervention was implemented in May 2021. For the primary analysis, we will calculate the mean and SD of ΔVAS5 on PODs 1 and 2 and the within-study difference in ΔVAS5. The treatment effect will be estimated by dividing the mean ΔVAS5 in the within-subject difference by 2 and calculating the P value using an unpaired t test. For the secondary analysis, we will calculate the mean and SD of ΔVAS15 on PODs 1 and 2 and the within-study difference in ΔVAS15. The treatment effect will be estimated as in the primary analysis. Conclusions: This trial will provide exploratory evidence of the efficacy and safety of an ibuprofen gargle for pain reduction after mandibular third molar extraction. Trial Registration: Japan Registry of Clinical Trials jRCTs051210022; https://tinyurl.com/39ej23zu International Registered Report Identifier (IRRID): DERR1-10.2196/35533

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Abbreviations

CRF: case report form

IP: ibuprofen-placebo

jRCT: Japan Registry of Clinical Trials

NSAID: nonsteroidal anti-inflammatory drug

PI: placebo-ibuprofen

POD: postoperative day

VAS: visual analog scale

Edited by T Leung; submitted 10.12.21; peer-reviewed by R Boyapati, R Leonardi; comments to author 03.01.22; revised version

received 12.02.22; accepted 22.04.22; published 16.05.22

Please cite as:

Kakei Y, Ioroi T, Ito T, Okazaki Y, Hasegawa T, Yano I, Akashi M

Efficacy of Ibuprofen Gargle for Postoperative Pain After Mandibular Third Molar Extraction: Protocol for a Phase II,

Placebo-Controlled, Double-Blind, Randomized Crossover Trial

JMIR Res Protoc 2022;11(5):e35533

URL: https://www.researchprotocols.org/2022/5/e35533

doi: 10.2196/35533

PMID: 35459640

https://www.researchprotocols.org/2022/5/e35533

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Kakei et al

©Yasumasa Kakei, Takeshi Ioroi, Takahiro Ito, Yutaro Okazaki, Takumi Hasegawa, Ikuko Yano, Masaya Akashi. Originally

published in JMIR Research Protocols (https://www.researchprotocols.org), 16.05.2022. This is an open-access article distributed

under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits

unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research

Protocols, is properly cited. The complete bibliographic information, a link to the original publication on

https://www.researchprotocols.org, as well as this copyright and license information must be included.

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