Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial.

BACKGROUND: Endoscopic Retrograde Cholangiopancreatography (ERCP) is a complex endoscopic procedure that requires moderate to deep sedation. Propofol is the sedative agent of choice for sedation in ERCP due to its fast distribution and fast elimination time without a cumulative effect after infusion, resulting in shorter recovery time. Benzydamine hydrochloride is a topical non-steroidal anti-inflammatory drug that has analgesic, local anesthetic, and anti-inflammatory effects that have been known to be effective in reducing postoperative sore throat. Combination of propofol and topical analgesic may provide adequate sedation and reduce propofol consumption. This study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the ERCP procedure. METHODS: This study was a single-blind randomized controlled trial for patients undergoing ERCP procedures at Cipto Mangunkusumo Hospital from August to September 2018. A total of 72 subjects were recruited consecutively and randomly assigned into two groups. The first group received 15 mL of 0.15% benzydamine hydrochloride mouthwash prior to the procedure, whereas the second group received 15 mL of water mouthwash. Additional propofol was administered when patient moved or Ramsay Sedation Scale rose above 4. Cumulative propofol consumption per kg body weight per minute and incidence of postoperative sore throat were recorded in each group. Incidence of desaturation, postoperative nausea vomitting, and dysphagia were also recorded. Data analysis was performed with Statistical Package for the Social Sciences. RESULTS: Cumulative propofol consumption per minute per kg body weight in the benzydamine hydrochloride group was 152.7 (91.9-238.8) mcg/kg/minute, while in the control group was 200.05 (114.4-380.2) mcg/kg/ minute (p = < 0.001). The incidence of sore throat on the 0th, 2nd, and 4th hour for the benzydamine hydrochloride group was 11.4, 11.4, and 5.7%, while in the control group was 50, 52.8, and 36.1% (p = < 0.001, < 0.001, 0.003). Desaturation was found in control group whereas none in benzydamine hydrochloride group. Complaints of nausea and vomiting were comparable in both groups. CONCLUSION: Benzydamine hydrochloride gargling was effective in reducing cumulative propofol consumption in the ERCP procedure. TRIAL REGISTRATION: Study was registered retrospectively in ClinicalTrials.gov with NCT04167592 on November 8th 2019.

Effects of benzydamine hydrochloride on postoperative sore throat after extubation in children: a randomized controlled trial.

BACKGROUND: Postoperative sore throat (POST) is a common, undesirable result of endotracheal intubation during general anaesthesia. This study aimed to evaluate the effectiveness of benzydamine hydrochloride (BH) spray in reducing the incidence of POST in paediatric patients. METHODS: This randomized, double-blind, prospective study included 142 children 6-12 years of age, who were randomly assigned to receive either BH spray or control. After induction of anaesthesia, direct laryngoscope was placed and BH spray was applied to the upper trachea and vocal cord in the BH group and intubation was performed using a cuffed tube lubricated with normal saline. Intubation in the control group was performed using a cuffed tube lubricated with normal saline without any intervention. The balloon was inflated to a pressure of 20 cmH2O. Patients were extubated after fully awakened and transferred to the post-anaesthetic care unit (PACU), where they were examined for the presence of POST and any adverse events 30 min after arrival to the PACU. Postoperative pain was evaluated using a smartphone application. RESULTS: Seventy-one patients were allocated to each group. The incidence of POST in the BH group did not differ from that in the control group (control: BH = 35 (49.3%): 42 (59.2%); P = 0.238); postoperative pain was also similar between the groups. Other complications, such as breath holding, secretions, coughing, laryngospasm and desaturation events, did not differ between the groups. CONCLUSIONS: Application of prophylactic BH spray to the vocal cords and upper trachea was not proven to reduce POST in paediatric patients. TRIAL REGISTRY: NCT03074968 (ClinicalTrials.gov, Feb 26, 2017).

Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine.

Purpose: A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind, four-parallel group, tolerability, and pharmacokinetic Phase I study in healthy women. Methods: The fixed-dose combination was compared to econazole and benzydamine single-drug formulations and with placebo after daily applications for 3 consecutive days. Safety and tolerability were evaluated recording the adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs. Econazole, benzydamine, and its metabolite benzydamine N-oxide pharmacokinetics were investigated after single and multiple applications. Results: Local reactions were generally absent. Pruritus and pain at the application site were infrequently reported. According to the subjects' evaluations, the overall tolerability of the ovules was rated as excellent or good. No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed. Very low econazole, benzydamine, and benzydamine-N-oxide concentrations were measured in plasma, though quantifiable in almost all samples. Conclusion: The tested fixed-dose combination showed a good safety profile consistently with the known tolerability of both active substances. In addition, the confirmed low bioavailability of the drugs excludes the possibility of any accumulation effects and limits the risk of undesired systemic effects. This trial is registered at ClinicalTrials.gov with the identifier NCT02720783 last updated on 07 February 2017.

The effect of benzydamine hydrochloride on preventing postoperative sore throat after total thyroidectomy: a randomized-controlled trial.

PURPOSE: We compared the effects of benzydamine hydrochloride (BH), 10% lidocaine, and normal saline spray on preventing postoperative sore throat (POST) in patients who underwent total thyroidectomy (TT). METHODS: In this prospective, randomized, parallel-group, double-blind study, the incidence of POST at six hours after tracheal extubation was compared among three groups as a primary outcome. American Society of Anesthesiologists physical status I-II patients undergoing elective TT under general anesthesia were enrolled. Patients were randomly stratified into group C (n = 33, normal saline), group L (n = 33, 10% lidocaine), or group B (n = 33, 0.3% BH). The participants, caregiver, and investigator were blinded to group assignment. Each study drug was sprayed three times on the endotracheal tube (ETT) cuff ten seconds before intubation. Incidence and severity of POST were recorded within 24 hr postoperatively (during postanesthesia care unit stay, and at six, 12, and 24 hr after extubation). P values were adjusted for multiple comparisons. RESULTS: Ninety-nine patients were enrolled. Eighty-seven patients completed the study. The incidence of POST at six hours after tracheal extubation was similar among the three groups (group C: 31 [93.9%], group L: 29 [87.9%], and group B: 27 [81.8%]; P = 0.38). Nevertheless, the incidence of POST was significantly different among the three groups at 12 and 24 hr after TT (12 hr: P = 0.002, 24 hr: P = 0.01). The severity of POST after tracheal extubation was statistically different among the study groups (6 hr: P = 0.04, 12 hr: P = 0.01). No adverse effects were observed. CONCLUSION: Application of BH spray on the ETT cuff reduced the incidence and severity of POST at 12 hr after TT. We suggest this method to be a non-invasive and effective management option for POST without serious side effects. TRIAL REGISTRATION: Clinical Research Information Service (KCT0002627); registered 24 November, 2017.

RéSUMé: OBJECTIF: Nous avons comparé les effets de la vaporisation de chlorhydrate de benzydamine (CB), de lidocaïne 10 %, ou de solution saline sur la prévention des maux de gorge postopératoires chez les patients subissant une thyroïdectomie totale (TT). MéTHODE: Dans cette étude prospective, randomisée, en parallèle et à double insu, l'incidence des maux de gorge postopératoires six heures après l'extubation trachéale a été comparée dans trois groupes pour répondre à notre critère d'évaluation principal. Des patients de statut physique I-II selon l'American Society of Anesthesiologists et subissant une TT non urgente sous anesthésie générale ont été recrutés. Les patients ont été aléatoirement alloués au groupe C (n = 33, solution saline), au groupe L (n = 33, lidocaïne 10 %), ou au groupe B (n = 33, CB 0,3 %). Les participants, anesthésistes et chercheurs ne connaissaient pas l'allocation de groupe. Chaque médicament étudié était vaporisé trois fois sur le ballonnet du tube endotrachéal (TET) dix secondes avant l'intubation. L'incidence et la gravité des maux de gorge postopératoires ont été enregistrées dans les 24 heures postopératoires (pendant le séjour en salle de réveil, et à six, 12 et 24 h après l'extubation). Les valeurs P ont été ajustées pour tenir compte des comparaisons multiples. RéSULTATS: Quatre-vingt-dix-neuf patients ont été recrutés. Quatre-vingt-sept patients ont terminé l'étude. L'incidence des maux de gorge postopératoires à six heures après l'extubation trachéale était semblable dans les trois groupes (groupe C : 31 [93,9 %], groupe L : 29 [87,9 %], et groupe B : 27 [81,8 %]; P = 0,38). Toutefois, l'incidence de maux de gorge postopératoires était significativement différente entre les trois groupes à 12 et 24 h après la TT (12 h : P = 0,002, 24 h : P = 0,01). La gravité des maux de gorge postopératoires après l'extubation trachéale était différente d'un point de vue statistique entre les groupes à l'étude (6 h : P = 0,04, 12 h : P = 0,01). Aucun effet secondaire indésirable n'a été observé. CONCLUSION: Le recours à une vaporisation de chlorhydrate de benzydamine sur le ballonnet du tube endotrachéal a réduit l'incidence et la gravité des maux de gorge postopératoires à 12 h après une thyroïdectomie totale. Selon nos résultats, cette méthode constitue une option de prise en charge non invasive et efficace des maux de gorge postopératoires sans effets secondaires importants. ENREGISTREMENT DE L'éTUDE: Clinical Research Information Service (KCT0002627); enregistrée le 24 novembre 2017.

Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis.

PURPOSE: The purpose of the study is to compare the efficacy of benzydamine HCl with sodium bicarbonate in the prevention of concurrent chemoradiation-induced oral mucositis in head and neck cancer patients. METHODS: Sixty locally advanced head and neck cancer patients treated with high-dose radiotherapy concurrently with platinum-based chemotherapy were randomly assigned to receive either benzydamine HCl or sodium bicarbonate from the first day of treatment to 2 weeks after the completion of treatment. The total score for mucositis, based on the Oral Mucositis Assessment Scale (OMAS), was used for the assessment, conducted weekly during the treatment period and at the fourth week of the follow-up. Pain score, all prescribed medications, and tube feeding needs were also recorded and compared. RESULTS: The median of total OMAS score was statistically significant lower in patients who received benzydamine HCl during concurrent chemo-radiotherapy (CCRT) than in those who received sodium bicarbonate, (p value < 0.001). There was no difference in median pain score, (p value = 0.52). Nineteen percent of patients in sodium bicarbonate arm needed oral antifungal agents whereas none in the benzydamine HCl arm required such medications, (p value = 0.06). Tube feeding needs and the compliance of CCRT were not different between the two study arms. CONCLUSIONS: For patients undergoing high-dose radiotherapy concurrently with platinum-based chemotherapy, using benzydamine HCl mouthwash as a preventive approach was superior to basic oral care using sodium bicarbonate mouthwash in terms of reducing the severity of oral mucositis and encouraging trend for the less need of oral antifungal drugs.

Intravenous self-administration of benzydamine, a non-steroidal anti-inflammatory drug with a central cannabinoidergic mechanism of action.

Benzydamine (BZY) is a non-steroidal anti-inflammatory drug used for the topical treatment of inflammations of the oral and vaginal mucosae. Virtually nothing is known about the central pharmacological actions of BZY. Yet there are reports of voluntary systemic overdosage of BZY in drug addicts, resulting in a euphoric, hallucinatory state. In the present study, we investigated the reinforcing properties of BZY in a rat self-administration paradigm. We found that BZY has a powerful reinforcing effect and that this effect is greatly facilitated in animals that already had substance experience, having previously self-administered heroin and cocaine, indicating cross sensitization between BZY and other common drugs of abuse. We then assessed the effect of BZY on prelimbic cortex-to-nucleus accumbens glutamatergic transmission, using field recordings in rat parasagittal brain slices. BZY dose-dependently reduced both field excitatory post synaptic potential amplitude and paired pulse ratio, suggesting a presynaptic mechanism of action. Similarly to the in vivo paradigm, also the electrophysiological effects of BZY were potentiated in slices from animals that had undergone cocaine and heroin self-administration. Furthermore, BZY-induced Long Term Depression (LTD)-like responses in the prelimbic cortex-to-nucleus accumbens circuitry were significantly reduced in the presence of the CB1 receptor antagonist AM251. These findings provide firm evidence of the abuse liability of BZY and suggest a possible cannabinoidergic mechanism of action. Further research is needed in order to give insights into the molecular mechanism underlying BZY psychoactive and reinforcing effects, to better understand its abuse potential.

Topical benzydamine hydrochloride for prevention of postoperative sore throat in adults undergoing tracheal intubation for elective surgery: a systematic review and meta-analysis.

Postoperative sore throat has a negative impact on patient satisfaction and recovery. Benzydamine hydrochloride is a non-steroidal anti-inflammatory drug available for topical use. We performed a systematic review and meta-analysis to assess the efficacy and safety of topical application of benzydamine to prevent postoperative sore throat in adults undergoing elective surgery under general anaesthesia. We searched PubMed, EMBASE, Web of Science and the Cochrane Central Register of Controlled Trials to identify relevant randomised controlled trials and pooled the data using a random effects model. The primary outcomes were the incidence and severity of sore throat 24 h after surgery/extubation, and adverse events. The quality of evidence was assessed using the grading of recommendations, assessment, development and evaluation (GRADE) criteria. Thirteen randomised controlled trials involving 1842 patients were included. Compared with control patients who did not receive analgesia, benzydamine was associated with a decreased incidence of postoperative sore throat, with a risk ratio (95%CI) of 0.31 (0.20-0.47), but not with significantly reduced severity, the standardised mean difference (95%CI) being -0.27 (-0.63 to 0.08). There were no significant adverse events related to benzydamine. Benzydamine was also associated with a reduced incidence of postoperative sore throat when compared with lidocaine, with a risk ratio (95%CI) of 0.18 (0.07-0.43). We judged the evidence for the outcome 'incidence of postoperative sore throat' as high quality.

Comparison of Clinical Efficacies of Preoperatively Initiated Naproxen Sodium-Codeine Phosphate in Combination, Diclofenac Potassium, and Benzydamine Hydrochloride for Pain, Edema, and Trismus After Extraction of Impacted Lower Third Molar: A Randomized Double-Blind Study.

PURPOSE: The aim of this study was to compare the clinical efficacies of naproxen sodium-codeine phosphate in combination, benzydamine hydrochloride, and diclofenac potassium for pain, edema, and trismus after lower third molar extraction. MATERIALS AND METHODS: Ninety healthy volunteers in whom impacted third molar extraction was indicated were randomly distributed into 3 groups. One hour before the tooth-extraction process, patients were administered one of the following drugs: naproxen sodium, 550 mg, and codeine phosphate, 30 mg, in a tablet; diclofenac potassium, 50 mg, in a coated pill; or benzydamine hydrochloride, 50 mg, in a coated pill. Pain assessment was conducted via a visual analog scale; edema assessment, by measuring the distances between predetermined facial landmarks; and trismus assessment, by measuring interincisal distance. Regarding rescue analgesics (paracetamol, 500 mg), the number and time of use by patients were recorded. RESULTS: Naproxen sodium-codeine phosphate was more effective for pain, edema, and trismus than diclofenac potassium and benzydamine hydrochloride (P < .05). Benzydamine hydrochloride yielded similar clinical responses to diclofenac potassium (P > .05). No drug-related side effects were observed. CONCLUSIONS: Naproxen sodium-codeine phosphate constitutes the drug of choice after the extraction of a patient's impacted lower third molar. Benzydamine hydrochloride has similar efficacy to diclofenac potassium, and it can be used as a nonsteroidal anti-inflammatory analgesic drug.

Vaginal Delivery of Benzydamine Hydrochloride through Liposomes Dispersed in Mucoadhesive Gels.

Liposomal vaginal drug delivery systems are important strategy in the treatment of both topical and systemic diseases. The aim of this study was to develop a vaginal delivery system for benzydamine hydrochloride (BNZ) loaded liposomes dispersed into mucoadhesive gels. The delivery system was also designed for a once a day dosage and to obtain controlled release of the BNZ. For this purpose BNZ containing gel formulations using hydroxypropyl methylcellulose (HPMC) K100M and Carbopol® 974P, which are composed of polymers that show promising potential as mucoadhesive vaginal delivery systems, were developed. In addition, a BNZ containing liposome formulation was developed for vaginal administration. To improve the vaginal retention time, liposome was incorporated in HPMC K100M and Carbopol® 974P gel formulations. This system is called lipogel. The developed BNZ liposomes have a slightly negative zeta potential (-1.50±0.16 mV), a 2.25±0.009 µm particle size and a 34% entrapment efficiency. These gels and lipogels have appropriate pH, viscosity, textural properties and mucoadhesive value for vaginal administration. Lipogels were found to be the best formulations for in vitro diffusion and ex vivo mucoadhesion. The work of mucoadhesion obtained from liposomes was in the range of 0.027±0.045 and 0.030±0.017 mJ/cm2, while the value obtained from lipogels was between 0.176±0.037 and 0.243±0.53 mJ/cm2. N1 and N2 lipogel formulations diffused 57 and 67% of BNZ respectively at the end of 24 h. Moreover, a higher mucoadhesion, which increases drug residence time in comparison to liposomes, could improve BNZ efficacy. In conclusion, BNZ mucoadhesive vaginal lipogel formulations can be promising alternatives to traditional dosage forms for vaginal topical therapy.

Effect of prophylactic benzydamine hydrochloride on postoperative sore throat and hoarseness after tracheal intubation using a double-lumen endobronchial tube: a randomized controlled trial.

PURPOSE: We evaluated the prophylactic effect of benzydamine hydrochloride (BH) spray on postoperative sore throat and hoarseness secondary to intubation with a double-lumen endobronchial tube (DLT). METHODS: Ninety-two adult patients undergoing thoracic surgery using DLT intubation were studied. The DLT cuff and oropharyngeal cavity were sprayed with normal saline (Group S; n = 46) or BH (Group BH; n = 46) prior to intubation. Postoperative sore throat and hoarseness were evaluated at one, six, and 24 hr after surgery. Sore throat was evaluated using a 0-100 mm visual analogue scale (VAS). Hoarseness was defined as a change in voice quality. RESULTS: Compared with Group S, postoperative sore throat occurred less frequently in Group BH at one hour (mean difference, 28.3%; 95% confidence interval [CI], 8.7 to 45.1; P = 0.01), at six hours (mean difference, 32.6%; 95% CI, 12.6 to 49.2; P < 0.01), and at 24 hr (mean difference, 28.3%; 95% CI, 9.3 to 44.7; P = 0.01) after surgery. Group BH had lower VAS scores for postoperative sore throat at one hour (mean difference, 12.8; 95% CI, 4.9 to 20.7), at six hours (mean difference, 11.9; 95% CI, 4.8 to 19.1; P < 0.01), and at 24 hr (mean difference, 5.3; 95% CI, 0.9 to 9.7; P = 0.01) after surgery. Hoarseness also occurred less frequently in Group BH at one hour (mean difference, 23.9%; 95% CI, 6.8 to 39.6; P = 0.01), at six hours (mean difference, 23.9%; 95% CI, 7.4 to 39.3; P = 0.01), and at 24 hr (mean difference, 21.7%; 95% CI, 5.5 to 37.0; P = 0.02) after surgery (P < 0.01). CONCLUSIONS: Prophylactic application of BH to the DLT cuff and oropharyngeal cavity reduces the incidence and severity of postoperative sore throat and the incidence of hoarseness associated with DLT intubation. The trial was registered at the Clinical Research Information Service (KCT0001068).

Treatment of oral mucositis pain following radiation therapy for head-and-neck cancer using a bioadhesive barrier-forming lipid solution.

PURPOSE: CAM2028, a vehicle that forms a bioadhesive lipid barrier when applied to the oral mucosa, was developed as a carrier system for local delivery of benzydamine, an NSAID used for pain relief in oral mucositis. This trial compared the analgesic effect of CAM2028 plus benzydamine (CAM2028-benzydamine) with unmedicated CAM2028 (CAM2028-control) for the treatment of oral mucositis in patients with head-and-neck cancer. METHODS: Thirty-eight study participants were enrolled during their 3rd to 4th week of radiation therapy. Participants were required to have symptomatic oral mucositis (WHO Grade 2 or above) at screening and pain scores of at least 6 on an 11-point Likert scale at screening and on each day before treatment with study medication. After undergoing radiation, patients were administered a single dose of CAM2028-control or CAM2028-benzydamine 2 days apart, in a randomized crossover fashion. Pain was assessed over the following 8 h. RESULTS: With both treatments, patients experienced a mean 40 % decrease in pain intensity at 6 h (the primary study endpoint). Both treatments resulted in significant pain relief within 5 min of application that was evident during the entire 8-h assessment period. There was no difference in pain relief between the two interventions at any time point. Both treatments were safe and well tolerated. CONCLUSIONS: CAM2028-benzydamine and CAM2028-control were both efficacious in reducing pain in patients with oral mucositis related to radiation therapy for head-and-neck cancer. Analgesic effects of both medications were immediate, clinically significant, and persistent for up to 8 h.

Benzydamine hydrochloride on postoperative sore throat: a meta-analysis of randomized controlled trials.

PURPOSE: Sore throat is a common postoperative complaint. The etiology of postoperative sore throat (POST) is considered the result of damage to airway mucosa after insertion of a laryngeal mask airway device or endotracheal tube. This paper proposes benzydamine hydrochloride (BH), a topical nonsteroidal anti-inflammatory drug (NSAID) with additional analgesic and local anesthetic properties, for POST prevention. SOURCE: We systematically searched PubMed, EMBASE™, Cochrane, and other relevant databases for randomized controlled trials (RCTs) that investigated the outcome of topical application of BH vs non-application in patients undergoing general anesthesia. Using a random effects model, meta-analyses were conducted to assess the relative risks of the incidence of POST within 24 hr following the surgical procedure. The secondary outcomes included postoperative nausea and vomiting, dry mouth, coughing, and local irritation. PRINCIPAL FINDINGS: We reviewed five trials that included 824 patients in total. Our results indicated that the incidence of POST was significantly reduced in the BH group, with risk ratios (RRs) of 0.37 (95% confidence interval [CI]: 0.20 to 0.68) at zero to one hour, 0.39 (95% CI: 0.27 to 0.57) at one to two hours, 0.42 (95% CI: 0.22 to 0.81) at four to six hours, 0.29 (95% CI: 0.10 to 0.88) at six to 12 hr, and 0.32 (95% CI: 0.18 to 0.56) at 12 to 24 hr, compared with the control groups. Patients reported local irritation, but no major BH-related complications were observed. CONCLUSION: Our results indicate that the incidence of POST can be significantly reduced by prophylactic BH topical application to the oral cavity or airway devices. Further RCTs are required to overcome the limitations of heterogeneity and to determine the optimal dosage and application of BH for managing POST.

Efficacy of benzydamine hydrochloride dripping at endotracheal tube cuff for prevention of postoperative sore throat.

BACKGROUND: Postoperative sore throat (POST) is a frequent consequence following ETT intubation, which may negatively affect the postoperative course and patient satisfaction. Benzydamine hydrochloride is a topically-applied non-steroidal anti-inflammatory drug (NSAID). The authors evaluated the analgesic effect of benzydamine hydrochloride dripping on the ETT cuff on POST. MATERIAL AND METHOD: Eighty-six patients participated in this randomized controlled trial. They were assigned into either the benzydamine hydrochloride or the control group. The whole ETT cuff was dripped either with 3 ml (4.5 mg) of benzydamine hydrochloride or nothing five minutes prior to anesthesia induction. The incidence and severity of POST at 0, 2, 4, 6, 12 and 24 hours postoperatively were assessed. The potential adverse effects of benzydamine hydrochloride (throat numbness throat burning sensation, dry mouth, and thirst) were also evaluated. RESULTS: Twenty-five patients (58.14%) in each group had POST (p-value = 1). The severity of POST (calculated from affected patients) in both groups at different time points was not significantly different. Patients in the benzydamine hydrochloride group did not have a higher incidence of adverse effects. CONCLUSION: We found that dripping benzydamine hydrochloride on the ETT cuff neither reduced the incidence of POST nor increased the incidence of adverse effects in comparison with no intervention.

Effect of Honey-Lemon Spray Versus Benzydamine Hydrochloride Spray on Radiation-Induced Acute Oral Mucositis in Head and Neck Cancer Patients: A Pilot, Randomized, Double-Blind, Active-Controlled Clinical Trial.

Introduction: Oral mucositis (OM) is the most prevalent side effect in patients with head and neck cancer (HNC). It causes an obvious decrease in quality of life (QoL) in these patients, so different medications have been recommended for OM, however, without optimal response. This randomized trial aimed to assess the effects of a honey-lemon spray compared with benzydamine hydrochloride in prevention of radiation-induced OM in patients with HNC. Materials and Methods: Forty-six patients with HNC received external beam radiotherapy for 5 days per week. Patients were randomized to treatment with either benzydamine hydrochloride spray or honey-lemon spray for 5 weeks and continued for 1 week after the end of treatment. The oral cavity was examined weekly, with a score given to each site based on the degree of mucositis using a 4-point scale, and a mean mucositis score was calculated as the primary outcome. Occurrence of OM, pain, QoL, and adverse effects were defined as secondary outcomes. Patients, therapists, and outcome assessors were blinded to group allocation. Results: No significant group differences occurred in the mucositis score, pain, or QoL. Mucositis occurrence rates were higher in the benzydamine hydrochloride group compared with the honey-lemon group (hazard ratio = 2.1, 95% confidence interval: 1.1 to 4.2). Two patients in the honey-lemon group had mild nausea and burning throat; no adverse effects occurred in the benzydamine hydrochloride group. Conclusions: There were no significant group differences in mucositis severity between patients treated with honey-lemon spray and benzydamine hydrochloride. The potential preventive effects of honey-lemon spray need to be confirmed in further trials. The trial registration number is IRCT20161024030467N1.

The effectiveness of benzydamine hydrochloride spraying on the endotracheal tube cuff or oral mucosa for postoperative sore throat.

BACKGROUND: The etiology of postoperative sore throat (POST) is considered to be the result of laryngoscopy, intubation damage, or inflated cuff compression of the tracheal mucosa. In this study, we compared the effectiveness in alleviating POST using different approaches to benzydamine hydrochloride (BH) administration by spraying the endotracheal tube (ET) cuff or the oropharyngeal cavity, or both. METHODS: Three hundred eighty patients were included in this prospective and double-blind study, which was randomized into 4 groups: group A, oropharyngeal cavity spray of BH, and distilled water on the ET cuff; group B, both the oropharyngeal cavity and the ET cuff received BH spray; group C, the ET cuff received BH spray, and the oropharyngeal cavity received distilled water; and group D, distilled water sprayed on both the ET tube and into the oropharyngeal cavity. The patients were examined for sore throat (none, mild, moderate, severe) at 0, 2, 4, and 24 hours postextubation. RESULTS: The incidence of POST was 23.2%, 13.8%, 14.7%, and 40.4% in groups A, B, C, and D, respectively. POST occurred significantly less frequently in groups B and C compared with group D (odds ratio: 0.36; 95% confidence interval: 0.21-0.60; P < 0.05). However, there was no significant difference between groups A and D (odds ratio: 0.62; 95% confidence interval: 0.38-1.01). Moreover, there was no significant interaction between spraying BH over the oropharyngeal cavity and the ET cuff on the incidence of POST (P = 0.088). The severity of POST was significantly more intense in group D compared with groups B and C (P < 0.001). Group B had a significantly higher incidence of local numbness, burning, and/or stinging sensation compared with patients in group D (P < 0.05). CONCLUSIONS: This study indicates that spraying BH on the ET cuff decreases the incidence and severity of POST without increased BH-related adverse effects.

Effect on postoperative sore throat of spraying the endotracheal tube cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine.

BACKGROUND: Postoperative sore throat (POST) is a common complication after endotracheal intubation. We compared the effectiveness on POST of spraying the endotracheal tube (ETT) cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine. METHODS: Three hundred seventy-two patients were randomly allocated into 4 groups. The ETT cuffs in each group were sprayed with benzydamine hydrochloride, 10% lidocaine hydrochloride, 2% lidocaine hydrochloride, or normal saline before endotracheal intubation. After insertion, the cuffs were inflated to an airway leak pressure of 20 cm H(2)O. Anesthesia was maintained with propofol. The patients were examined for sore throat (none, mild, moderate, or severe) at 1, 6, 12, and 24 hours after extubation. RESULTS: The highest incidence of POST occurred at 6 hours after extubation in all groups. There was a significantly lower incidence of POST in the benzydamine group than 10% lidocaine, 2% lidocaine, and normal saline groups (P < 0.05) at each observation time point. At 6 hours after extubation, the incidence of POST was significantly lower in the benzydamine group (17.0%) compared with 10% lidocaine (53.7%), 2% lidocaine (37.0%), and normal saline (40.8%) groups (P < 0.05). The benzydamine group had significantly decreased severity of POST compared with the 10% lidocaine, 2% lidocaine, and normal saline groups (P < 0.05) at each observation time point. Compared with the 2% lidocaine and normal saline groups, the 10% lidocaine group had significantly increased severity of POST at 1, 6, and 12 hours after extubation. There were no significant differences among groups in local or systemic side effects. CONCLUSIONS: Spraying benzydamine hydrochloride on the ETT cuff is a simple and effective method to reduce the incidence and severity of POST.

Management of aphthous ulceration with topical quercetin: a randomized clinical trial.

AIM: Recurrent aphthous ulceration is the most commonly known oral mucosal disease. Quercetin is a useful therapeutic agent for the treatment of colitis and gastric ulcer. The objective of this study was to determine the effect of topical application of quercetin in the treatment of minor aphthous ulcers. METHODS AND MATERIALS: Forty male patients with no known pathology of the oral mucosa other than minor aphthous ulcers were enrolled in this study. Patients were randomly divided into two groups, each consisting of 20 patients. Group 1 (control group) patients used a benzydamine hydrochloride mouthwash three times daily. Group 2 patients placed two to three dabs of quercetin three times daily directly on their ulcers. Clinical evaluation of patients included assessment of ulcer size, pain measure, and interviews regarding the topical application of quercetin in terms of consistency, taste, local tolerability, and ease of application. RESULTS: The topical application of quercetin cream to minor mouth ulcers relieved pain and produced complete healing in seven of the Group 2 patients (35 percent) in 2-4 days, 18 patients (90 percent) in 4-7 days, and 20 patients (100 percent) in 7-10 days. When comparing the mean ulcer size after 10 days, lesions in the Group 2 patients were smaller than those in Group 1, and the size difference between the two groups was significantly different (p<0.004). Also, 90 percent of patients responded that they appreciated the ease of application when using the topical quercetin, and they did not object to its consistency or taste. CONCLUSION: Quercetin is a safe, well-tolerated, and highly effective promising new, adjunctive treatment for healing common aphthous ulcers. CLINICAL SIGNIFICANCE: Although aphthous ulcers typically resolve on their own in one to two weeks, the daily topical application of quercetin may be useful in accelerating the healing process of minor aphthous ulcers.

The effects of topical chlorhexidine-benzydamine spray on laryngeal mask airway application.

BACKGROUND: Laryngeal mask airway (LMA) use is very common during anesthesia practice. Sore throat, earache, hoarseness and swallowing difficulties may occur on LMA insertion. The primary aim of this study was to describe the effects of topical application of a spray formula of chlorhexidine gluconate and benzydamine hydrochloride (Kloroben® oral spray, 30 mL) on postoperative sore throat due to LMA use. The secondary aims were to evaluate earache, swallowing difficulty, nausea and vomiting and the hemodynamic responses due to LMA insertion and the incidence of coughing, tooth clenching, desaturation and laryngeal spasms during LMA removal. METHODS: After obtaining Institutional Ethics Committee approval and written informed consent (Ref no 29/15), a total of 100 adult patients were included. In Group C, four puffs of a spray formula of chlorhexidine gluconate and benzydamine hydrochloride were applied to the nasopharyngeal area 15 min before surgery. In Group S, 0.9% saline was applied, using the same protocol. RESULTS: When both groups were compared, more patients in Group S had cough, sore throat and swallowing difficulties one hour after surgery (P<0.05), but there was no statistically significant difference at 6, 12, and 24 h between the two groups (P>0.05). The incidence of nausea, vomiting, and earaches was similar in both groups at all measurement times (P>0.05). CONCLUSIONS: Preemptive topical benzydamine hydrochloride and chlorhexidine gluconate in a spray formula may decrease the incidence of sore throat, cough and swallowing difficulties associated with LMA use.

Formulation studies of benzydamine mucoadhesive formulations for vaginal administration.

BACKGROUND: Vaginal cavity represents a good site for drug administration and delivery. AIM: The aim of this work was the design of new mucoadhesive semisolid dosage forms for vaginal delivery of benzydamine. METHOD: Simple gels, obtained by using sodium carboxymethylcellulose (NaCMC) and hydroxyethylcellulose (HEC), were employed as water phase of an oil-in-water emulsion (O/W cream) to obtain emulgels, more stable and manageable than gels. Successively, in order to modify the emulgel consistency, the ingredient cetostearylic alcohol was replaced by the same amount of gel or vaseline. All the preparations were submitted to mucoadhesion and rheological, extrusion, and release studies and compared to market vaginal cream Tantum Rosa. RESULTS: HEC formulations showed good drug release profiles and good rheological behavior but low mucoadhesion strength, whereas NaCMC (4% gel) formulations had better drug release and very high mucoadhesive strength. However, the presence of NaCMC 4% conferred too much viscosity to the preparation. Taking into consideration all performances, the most suitable formulations for vaginal applications resulted in those containing NaCMC (3% gel) and with gel replacing cetostearylic alcohol as they showed good ex vivo performances in terms of manageability and high bioadhesion to vaginal mucosa.

Benzydamine hydrochloride buccal bioadhesive gels designed for oral ulcers: preparation, rheological, textural, mucoadhesive and release properties.

This study developed and examined the characterization of Benzidamine hydrochloride (BNZ) bioadhesive gels as platforms for oral ulcer treatments. Bioadhesive gels were prepared with four different hydroxypropylmethylcellulose (HPMC) types (E5, E15, E50 and K100M) with different ratios. Each formulation was characterized in terms of drug release, rheological, mechanical properties and adhesion to a buccal bovine mucosa. Drug release was significantly decreased as the concentration and individual viscosity of each polymeric component increased due to improved viscosity of the gel formulations. The amount of drug released for the formulations ranged from 0.76 +/- 0.07 and 1.14 +/- 0.01 (mg/cm2 +/- SD). Formulations exhibited pseudoplastic flow and all formulations, increasing the concentration of HPMC content significantly raised storage modulus (G'), loss modulus (G''), dynamic viscosity (eta') at 37 degrees C. Increasing concentration of each polymeric component also significantly improved the hardness, compressibility, adhesiveness, cohesiveness and mucoadhesion but decreased the elasticity of the gel formulations. All formulations showed non-Fickian diffusion due to the relaxation and swelling of the polymers with water. In conclusion, the formulations studied showed a wide range of mechanical and drug diffusion characteristics. On the basis of the obtained data, the bioadhesive gel formulation which was prepared with 2.5% HPMC K 100M was determined as the most appropriate formulation for buccal application in means of possessing suitable mechanical properties, exhibiting high cohesion and bioadhesion.