Oral flurbiprofen spray for postoperative sore throat and hoarseness: a prospective, randomized, double-blind, placebo-controlled study

Müderris, Togay; Tezcan, Günay; Sancak, Mecit; Gül, Fatih; Uğur, Gökçer

doi:10.23736/s0375-9393.18.12703-9

Cited by 17 publications

(15 citation statements)

References 29 publications

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“…The PubMed search identified 33 unique records, of which 15 were excluded as they did not meet the inclusion criteria based on title/abstract screening ( Figure 1). A total of 18 records underwent full text assessment: 17 were selected for inclusion in the final review (Table 1), and one study in POST was excluded as it evaluated a flurbiprofen dose lower than 8.75 mg. 39 In view of the heterogeneity of the data reported in the studies identified, it was not possible to conduct a metaanalysis. For example, studies varied with regard to the formulation by which the active ingredient was administered (lozenge, spray, and microgranules), the outcome measures investigated, the nature of data reported (some studies reported baseline and endpoint data, whereas others only reported efficacy in terms of percentage change from baseline) and the data reporting units.…”

Section: Resultsmentioning

confidence: 99%

“…25,26 It is most commonly used at a dose of 8.75 mg, based on the results of a dose-ranging study that demonstrated linear dose-response relationships for effectiveness and adverse events at doses between 5.0 mg and 12.5 mg. 27 Its use for the symptomatic relief of pharyngitis of viral, bacterial, or unknown etiology has been assessed in a number of studies. 17,22,25,26,[28][29][30][31][32][33][34][35][36][37][38] It has also been evaluated for the relief of postoperative sore throat POST, [39][40][41] a common complication of general anesthesia 42 and tonsillectomy 43 that can negatively impact patients' postoperative comfort.…”

Section: Introductionmentioning

confidence: 99%

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Locally Delivered Flurbiprofen 8.75 mg for Treatment and Prevention of Sore Throat: A Narrative Review of Clinical Studies

Looze

Shephard

Smith

2019

JPR

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Background: Antibiotics are inappropriately prescribed to many people with sore throat. As most cases of sore throat are viral and/or self-limiting, guidelines recommend symptomatic management as first-line treatment. This paper reviews the available clinical evidence for the efficacy and safety of low-dose (8.75 mg) flurbiprofen, locally delivered to the throat for the symptomatic management of pharyngitis/sore throat. Method: A literature search was performed on 27 February 2019 using PubMed. Studies that met the following criteria were included in a narrative review: (1) studies evaluating the effectiveness of flurbiprofen for pharyngitis/sore throat; (2) randomized controlled studies; (3) locally administered formulation of study drug/comparator; and (4) flurbiprofen administered at 8.75 mg dose (single-or multiple-dose administration). Results: A total of 17 papers were included in the review: 15 publications reporting data from nine unique clinical studies of flurbiprofen for acute pharyngitis, and two reporting studies of flurbiprofen for the prevention of postoperative sore throat (POST). Studies in acute pharyngitis demonstrated that single-and multiple-dose flurbiprofen 8.75 mg, locally administered in lozenge, spray or microgranule form, was well tolerated and provided early onset and long-lasting symptomatic relief from throat pain and soreness, sensation of swollen throat, difficulty swallowing, and other associated symptoms. This included patients with more severe symptoms, patients with confirmed Streptococcus A/C sore throat, and patients taking concomitant antibiotics. In addition, a single preoperative dose of flurbiprofen lozenge was shown to be effective for relieving early POST in patients undergoing general anesthesia. Conclusion: Locally administered, low-dose flurbiprofen offers a useful first-line treatment option for symptomatic relief in patients with "uncomplicated" acute pharyngitis/sore throat associated with upper respiratory tract infection, thus potentially helping to reduce unnecessary antibiotic prescribing. It also offers an effective preoperative treatment option for the reduction of early POST severity and incidence.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Locally Delivered Flurbiprofen 8.75 mg for Treatment and Prevention of Sore Throat: A Narrative Review of Clinical Studies

Looze

Shephard

Smith

2019

JPR

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“…4,[19][20][21][22][23] The efficacy of flurbiprofen spray has been evaluated in three randomized controlled studies in post-tonsillectomy pain and shown to be effective. [24][25][26] Flurbiprofen is available in spray and lozenge formulations at a low dose for relief of the sore throat pain due to inflammation. Local delivery of lowdose flurbiprofen may reduce the potential for systemic adverse effects compared with oral high-dose NSAIDs.…”

Section: Introductionmentioning

confidence: 99%

Determination of the Permeation and Penetration of Flurbiprofen into Cadaveric Human Pharynx Tissue

Turner¹,

Wevrett²,

Edmunds³

et al. 2020

CPAA

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Objective: Flurbiprofen 8.75 mg spray and lozenge have a rapid onset of action for sore throat relief, suggesting local action, although tissue penetration and the mechanism of local relief have not been determined. This investigation aimed to quantify the permeation and penetration of flurbiprofen, applied as local pharmaceutical forms, into full-thickness cadaveric human mucosal pharynx tissue, representing the clinical scenario as far as possible. Methods: A validated high-performance liquid chromatography method quantified the permeation and penetration of flurbiprofen (spray and lozenge formulations) into human cadaveric pharynx tissue using a micro Franz cell model mimicking physiological and anatomical conditions. Full-thickness mucosal pharynx tissue, consisting of oral epithelium, basement membrane, and lamina propria, was utilized to imitate the in vivo setting. Flurbiprofen was analyzed on the surface of the pharynx tissue, within the pharynx tissue and in receiver fluid, over 60 mins. Results: Flurbiprofen was detected in receiver fluid from 10 mins following spray application and was quantifiable from 20 mins. Flurbiprofen from lozenge was detected from 10 mins and was above the limit of quantitation in receiver fluid from 40 mins. Flurbiprofen recovered from the surface of the pharynx tissue was 24.45% and 8.48% of applied dose for spray and lozenge, respectively. Flurbiprofen recovered within pharynx tissue was 46.50% and 54.65% of applied dose for spray and lozenge, respectively. For flurbiprofen lozenge, recovery within pharynx tissue was 6-fold higher relative to recovery from the pharynx tissue surface. Conclusion: Flurbiprofen from spray and lozenge formulations penetrated human cadaveric pharynx tissue, indicating that flurbiprofen can reach all layers of the pharynx mucosal tissue, including the underlying lamina propria, which contains blood vessels and nerve fibers that contribute to pain during sore throat. This suggests that flurbiprofen may have a local mechanism of action for sore throat, although this has yet to be determined.

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“…Finally, we included 13 RCTs for this systematic review and meta-analysis (Fig. 1, Table 1) [7][8][9][21][22][23][24][25][26][27][28][29][30]. The inter-rater agreement between the four systematic reviewers, using the kappa statistic, was κ = 0.62.…”

Section: Search Resultsmentioning

confidence: 99%

Pharmacological Interventions for Post-operative Sore Throat (POST): A Network Meta-analysis

2020

Signa Vitae

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Background: To study the efficacy of current post-extubation pharmacologic treatments for postoperative sore throat (POST) prevention. Method: We searched nine databases for randomized controlled trials (RCTs) assessing the efficacy of post-extubation treatments in POST prevention. A network meta-analysis was used to pool the results. Results: Of the 124 records screened, we included 13 studies with 1820 patients. Ketorolac tromethamine was found to be the most effective with the lowest POST rates (P-score = 0.99), followed by ketamine (P-score = 0.68), amyl-m-cresol (P-score = 0.67), flurbiprofen (P-score = 0.66), benzydamine hydrochloride (P-score = 0.62), magnesium (P-score = 0.33), dexamethasone (P-score = 0.30), and lidocaine (P-score = 0.07). Moreover, the following treatments were found to be significantly effective in reducing POST in comparison to control/placebo treatment: ketorolac tromethamine (OR = 0.11; [95% CI=0.05 – 0.21]) followed by ketamine (OR = 0.32; [95% CI = 0.17 – 0.62]), amyl-m-cresol (OR = 0.32; [95% CI = 0.14 – 0.73]), flurbiprofen (OR = 0.33;[95% CI = 0.13 – 0.81]), and benzydamine hydrochloride (OR = 0.36; [95% CI = 0.24 –0.54]). Conclusion: Ketorolac tromethamine, ketamine, amyl-m-cresol, flurbiprofen, and benzydamine hydrochloride were found to be significantly effective in reducing POST. Moreover, ketorolac tromethamine was the most effective and significantly better than all other treatments in reducing POST rates.

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Oral flurbiprofen spray for postoperative sore throat and hoarseness: a prospective, randomized, double-blind, placebo-controlled study

Cited by 17 publications

References 29 publications

<p>Locally Delivered Flurbiprofen 8.75 mg for Treatment and Prevention of Sore Throat: A Narrative Review of Clinical Studies</p>

<p>Locally Delivered Flurbiprofen 8.75 mg for Treatment and Prevention of Sore Throat: A Narrative Review of Clinical Studies</p>

<p>Determination of the Permeation and Penetration of Flurbiprofen into Cadaveric Human Pharynx Tissue</p>

Pharmacological Interventions for Post-operative Sore Throat (POST): A Network Meta-analysis

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