Application of sequential multimodal analgesia before and after impacted mandibular third molar extraction: Protocol for a randomized controlled trial
Background: Several analgesics have been applied under various protocols to control the moderate-to-severe postoperative pain caused by the surgical extraction of an impacted mandibular third molar. However, a consensus on optimal pain management while minimizing side effects is yet to be reached. M...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-04-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865423000248 |
| _version_ | 1811170981914345472 |
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| author | Soo-Ho Kim Somi Kim Yoon-Seon Kim Mi-Kyoung Song Ji-Yeon Kang |
| author_facet | Soo-Ho Kim Somi Kim Yoon-Seon Kim Mi-Kyoung Song Ji-Yeon Kang |
| author_sort | Soo-Ho Kim |
| collection | DOAJ |
| description | Background: Several analgesics have been applied under various protocols to control the moderate-to-severe postoperative pain caused by the surgical extraction of an impacted mandibular third molar. However, a consensus on optimal pain management while minimizing side effects is yet to be reached. Methods: This multi-center, prospective, double-blind, randomized controlled trial aims to evaluate the efficacy and safety of sequential multimodal analgesia combined with postoperative zaltoprofen along with multiple preemptive analgesics. A total of 80 participants with bilateral impacted mandibular third molar from two hospitals were randomized into two groups. Two surgical extractions were performed at one-month intervals, and in a crossover design, celecoxib or tramadol/acetaminophen was administered before one extraction and placebo before the other extraction. Following extraction, all subjects took zaltoprofen for 5 days. The outcome measures included pain at specific times, time and intensity of the first pain onset after extraction, need of rescue drugs, and occurrence and frequency of side effects. Conclusions: This ongoing clinical trial was designed to provide evidence regarding a new protocol for effective postoperative pain management of a commonly performed surgical extraction. The results of this study will provide guidance to clinicians regarding the timing and combination of oral analgesics in various oral surgeries performed under local anesthesia. Trial registration: KCT0005450, registered on October 7, 2020. |
| first_indexed | 2024-04-10T17:05:51Z |
| format | Article |
| id | doaj.art-1489a3cb58cf48a690cca5989732f7c3 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-10T17:05:51Z |
| publishDate | 2023-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-1489a3cb58cf48a690cca5989732f7c32023-02-06T04:06:14ZengElsevierContemporary Clinical Trials Communications2451-86542023-04-0132101078Application of sequential multimodal analgesia before and after impacted mandibular third molar extraction: Protocol for a randomized controlled trialSoo-Ho Kim0Somi Kim1Yoon-Seon Kim2Mi-Kyoung Song3Ji-Yeon Kang4Department of Dentistry, Chungnam National University Hospital, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, South KoreaDepartment of Dentistry, Chungnam National University Sejong Hospital, 407, Dodam-dong, Sejong-si, 30099, South KoreaDepartment of Dentistry, Chungnam National University Sejong Hospital, 407, Dodam-dong, Sejong-si, 30099, South KoreaDepartment of Dentistry, Chungnam National University Hospital, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, South KoreaDepartment of Dentistry, Chungnam National University Hospital, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, South Korea; Department of Oral & Maxillofacial Surgery, College of Medicine, Chungnam National University, 266, Munhwa-ro, Jung-gu, Daejeon, 35015, South Korea; Corresponding author. Department of Dentistry, Chungnam National University Hospital, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, South Korea.Background: Several analgesics have been applied under various protocols to control the moderate-to-severe postoperative pain caused by the surgical extraction of an impacted mandibular third molar. However, a consensus on optimal pain management while minimizing side effects is yet to be reached. Methods: This multi-center, prospective, double-blind, randomized controlled trial aims to evaluate the efficacy and safety of sequential multimodal analgesia combined with postoperative zaltoprofen along with multiple preemptive analgesics. A total of 80 participants with bilateral impacted mandibular third molar from two hospitals were randomized into two groups. Two surgical extractions were performed at one-month intervals, and in a crossover design, celecoxib or tramadol/acetaminophen was administered before one extraction and placebo before the other extraction. Following extraction, all subjects took zaltoprofen for 5 days. The outcome measures included pain at specific times, time and intensity of the first pain onset after extraction, need of rescue drugs, and occurrence and frequency of side effects. Conclusions: This ongoing clinical trial was designed to provide evidence regarding a new protocol for effective postoperative pain management of a commonly performed surgical extraction. The results of this study will provide guidance to clinicians regarding the timing and combination of oral analgesics in various oral surgeries performed under local anesthesia. Trial registration: KCT0005450, registered on October 7, 2020.http://www.sciencedirect.com/science/article/pii/S2451865423000248Sequential multimodal analgesiaPreemptive analgesiaImpacted third molar extraction |
| spellingShingle | Soo-Ho Kim Somi Kim Yoon-Seon Kim Mi-Kyoung Song Ji-Yeon Kang Application of sequential multimodal analgesia before and after impacted mandibular third molar extraction: Protocol for a randomized controlled trial Contemporary Clinical Trials Communications Sequential multimodal analgesia Preemptive analgesia Impacted third molar extraction |
| title | Application of sequential multimodal analgesia before and after impacted mandibular third molar extraction: Protocol for a randomized controlled trial |
| title_full | Application of sequential multimodal analgesia before and after impacted mandibular third molar extraction: Protocol for a randomized controlled trial |
| title_fullStr | Application of sequential multimodal analgesia before and after impacted mandibular third molar extraction: Protocol for a randomized controlled trial |
| title_full_unstemmed | Application of sequential multimodal analgesia before and after impacted mandibular third molar extraction: Protocol for a randomized controlled trial |
| title_short | Application of sequential multimodal analgesia before and after impacted mandibular third molar extraction: Protocol for a randomized controlled trial |
| title_sort | application of sequential multimodal analgesia before and after impacted mandibular third molar extraction protocol for a randomized controlled trial |
| topic | Sequential multimodal analgesia Preemptive analgesia Impacted third molar extraction |
| url | http://www.sciencedirect.com/science/article/pii/S2451865423000248 |
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