Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 10, 2021
Open Peer Review Period: Dec 8, 2021 - Dec 21, 2021
Date Accepted: Apr 22, 2022
Date Submitted to PubMed: Apr 23, 2022
(closed for review but you can still tweet)
Efficacy of ibuprofen gargle for postoperative pain after mandibular third molar extraction: protocol for a phase II, placebo-controlled, double-blind, randomized crossover trial
ABSTRACT
Background:
Extraction of mandibular third molars is one of the most commonly performed oral surgical procedures, and non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for pain management. Oral administration of NSAIDs can produce various adverse events such as gastrointestinal disorders, renal and hepatic dysfunction, and platelet dysfunction. Topical use of analgesics has been proposed as an alternative 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 in comparison with a placebo gargle.
Objective:
This will be the first clinical study to evaluate the efficacy of ibuprofen gargle for relieving postoperative pain after extraction of mandibular third molars.
Methods:
This study will be performed at Kobe University Hospital. Participants (n = 40) will be randomized equally to one of two groups. The IP group will receive ibuprofen gargle on postoperative day (POD) 1 and placebo gargle on POD 2. The PI group will receive placebo gargle on POD 1 and ibuprofen gargle on POD 2. Both groups will receive ibuprofen gargle on PODs 3 to 5 at least once daily. The primary objective is to estimate the within-subject difference in a visual analogue scale (VAS) before and 5 minutes after use of ibuprofen or placebo gargle on PODs 1 and 2. The secondary objectives are to estimate the within-subject difference in ΔVAS before and 15 minutes after use of ibuprofen or placebo gargle on PODs 1 and 2, the ΔVAS before and after 5 or 15 minutes of use of ibuprofen gargle on PODs 3 to 5, the overall effectiveness (self-completion, five scales) on PODs 1 to 5, the daily frequency of use (ibuprofen or placebo gargle and analgesics) on PODs 1 to 7, and the occurrence of adverse events.
Results:
The Kobe university Certified Review Board approved the study. The intervention was implemented in May 2021.
Conclusions:
This trial will provide exploratory evidence of the efficacy and safety of ibuprofen gargle for pain reduction after mandibular third molar extraction. Clinical Trial: Japan Registry of Clinical Trials (jRCT) identifier: jRCTs051210022. Registered on 10 May 2021.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.