Efficacy of 0.1% Xylometazoline-Hydrochloride Nasal Decongestant Spray in Postoperative Sign/Symptom Relief Following Septoplasty: A Randomized Control Trial.

Objective:This study evaluated the efficacy of 0.1% xylometazoline-hydrochloride nasal decongestant spray compared to 0.9% saline nasal spray in relieving post-septoplasty clinical nasal findings and symptoms. Methods: This triple-blinded randomized-clinical-trial was conducted in 2 tertiary-care hospitals in Karachi-Pakistan. A total of 120 septoplasty patients were recruited from June 20, 2022, to June 20, 2023. Randomly equally-assigned participants received either 0.9% isotonic-saline (control group) or 0.1% xylometazoline-hydrochloride (intervention group) nasal sprays. Participants were instructed to use nasal sprays for 1 week, twice daily, with a 12 hour interval between the 2 doses as a single spray per nostril. Follow-up assessments were conducted on days 3 and 7 after surgery. Postoperative symptoms, nasal-endoscopic findings, adverse-effects, and patient satisfaction were compared using Chi-square test and a P value of <.05 was considered significant. Results: Of 120 participants, 106 were analyzed with 53 participants in each group. By the end of third postoperative day, intervention group exhibited significantly lower rates of self-reported symptoms, including bleeding (7.5%:54.7%), nasal obstruction (3.8%:45.3%), headache (1.9%:30.2%), pain (3.8%:7.5%), as well as clinical nasal findings, including nasal edema (1.9%:58.5%), crusting (11.3%:58.5%), nasal discharge (9.4%:22.6%), and nonhealed scarring (18.9%:58.5%), compared to control group (P value < .001). On the seventh day, intervention group exhibited absence of self-reported symptoms and clinical nasal findings, whereas control group still experienced moderate symptoms (P value < .001). Intervention group had significantly higher patient satisfaction (P value < .001). Conclusions: Xylometazoline spray is highly effective in relieving post-septoplasty clinical nasal findings and symptoms, without adverse effects, indicating potential for wider clinical utilization.Trial Registration: UMIN Clinical-trial-registry: UMIN000052217. (https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059598).

Cocaine versus xylometazoline to prevent epistaxis after nasotracheal intubation: A randomized trial.

BACKGROUND: Nasotracheal intubation is associated with a risk of epistaxis. Several drugs, including cocaine and xylometazoline may be used as decongestants prior to nasotracheal intubation to prevent this. We hypothesized that xylometazoline would prevent epistaxis more effectively than cocaine, demonstrated by a lower proportion of patients with bleeding after nasotracheal intubation. METHODS: We conducted a single-center, outcome assessor and analyst-blinded, clinical randomized controlled trial following approval from the local research ethics committee and the national medicine agency. Written informed consent was obtained from all patients. Patients scheduled for surgery under general anesthesia with nasotracheal intubation were randomized to receive either 2 mL 4% cocaine or 2 mL 0.05% xylometazoline prior to nasotracheal intubation. Immediately following intubation, epistaxis was evaluated by the blinded intubating anesthetist on a four-point scale. We measured heart rate and blood pressure the first 5 min after drug administration. Adverse events were followed up after 24 h. RESULTS: A total of 53 patients received cocaine and 49 patients received xylometazoline. Bleeding occurred in 32 patients receiving cocaine (60.4%) and in 34 patients receiving xylometazoline (69.4%) (p = .41, Fisher's exact test) with a difference of 9.0% (95% CI: -9.4% to 27%). There was no statistically significant difference between groups regarding the heart rate or blood pressure. No adverse cardiac events were recorded in either group. CONCLUSION: We found no statistically significant difference between cocaine and xylometazoline in preventing epistaxis after nasotracheal intubation, and the choice of vasoconstrictor should be based on other considerations, such as pricing, availability and medicolegal issues.

A Novel Spectrofluorimetric Determination of Antazoline and Xylometazoline in their Ophthalmic Formulation; Green Approach and Evaluation.

A green developed spectrofluorimetric method has been applied for Antazoline (ANT) and Xylometazoline (XLO) determination in both pharmaceutical formulation and pure form. The developed method is synchronous spectrofluorimetry coupled with the second derivative mathematical tool for the determination of antazoline and xylometazoline in their dosage form. The developed method depends on reacting the cited drugs with dansyl chloride, a suitable derivatizing agent, to generate highly fluorescent derivatives. The products formed were measured at emission wavelengths; 703.0 and 712.0 nm after being excited at wavelengths; 350.0 and 355.0 nm for antazoline and xylometazoline, respectively. Synchronous spectrofluorimetry coupled with second derivative mathematical tool was developed and optimized using fluorescence data manager software generating second derivative peak amplitudes at 556.5 nm for antazoline and 598.0 nm for xylometazoline. Linear responses have been represented over a wide range of concentration 0.5-12.0 µg/mL for antazoline and 0.1-10.0 µg/mL for xylometazoline, correspondingly. Method validation was successfully applied. Additionally, statistical comparison of developed method with official ones has been carried out where no significant difference was found. Evaluation of the method's greenness was proven using several assessment tools. Indeed, the method developed is found to be precise, sensitive, and discriminating to assess the cited drugs for regular analysis.

A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold.

BACKGROUND: The common cold is a frequent, acute, and mild upper respiratory human disease. Nasal congestion has been considered the most bothersome symptom in the common cold, impacting quality of life (QoL). Topical decongestants containing steroids benefit QoL in allergic rhinitis, but no published research has assessed the impact of topical decongestants on QoL in the common cold. OBJECTIVE: To evaluate the effects of xylometazoline hydrochloride 0.1% (Otrivin, GSK Consumer Healthcare SARL, Switzerland) for up to 7 days on QoL in participants with nasal congestion associated with the common cold. DESIGN: This was a decentralized, longitudinal, open-label study. METHODS: The study enrolled 136 participants (⩾18 years) with early symptoms of the common cold, of which 102 were included in the modified intention-to-treat (mITT) population. Within 24 h of study product receipt, participants confirmed a 'plugged nose' and ⩾1 other common cold symptom. Primary endpoints were Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) total score, total and individual symptom scores, and total QoL score. Secondary endpoints were additional QoL scores. Exploratory and post hoc analyses included median days to resolution for each QoL factor and analyses of five QoL categories. RESULTS: Consistent improvements in symptoms and QoL were seen in the mITT population. From day 1, improvements were seen in the 'plugged nose' symptom (p = 0.0023), WURSS-21 total QoL score, and all individual QoL scores (p < 0.0001 for all). After the last dose needed, significant improvements were seen in sleep quality (73%), vitality (76%), physical activity (71%), social activity (80%), and sensation (81%). No serious or unexpected adverse events were reported. CONCLUSION: This study is the first to demonstrate in a real-life setting that treating nasal congestion in adults with xylometazoline hydrochloride 0.1% during the common cold positively impacts QoL factors relevant to daily living [Otrivin: Quality of Life (QoL) Impact in a Real-World Setting; https://clinicaltrials.gov/study/NCT05556148].

Impact of xylometazoline hydrochloride 0.1% on quality of life in people with blocked nose associated with the common coldThe common cold is a widespread, mild respiratory illness for which a hallmark symptom is a blocked or stuffy nose, which makes breathing and sleeping difficult. This study focused on how a nasal spray called Otrivin (containing xylometazoline hydrochloride 0.1%) impacts the quality of life (QoL) of people suffering from nasal congestion due to the common cold.Participants answered a questionnaire called the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21), which helped understand how people experience respiratory symptoms and how different aspects of QoL were impacted. Participants also responded to eight additional QoL questions not covered in the WURSS-21.The results showed that from the first day of using the nasal spray, participants experienced significant relief from the blocked nose symptom and reported an overall improvement in their QoL and well-being, such as in sleep quality, energy levels, senses, and physical and social activities.In conclusion, this real-world study demonstrated that using xylometazoline hydrochloride 0.1% nasal spray during the common cold can significantly improve nasal congestion and various aspects of a person's daily life. These findings provide valuable evidence for using this nasal spray to relieve symptoms and enhance the overall well-being of individuals with the common cold.

Hemorrhagic stroke caused by xylometazoline poisoning.

An increase in the use of over-the-counter medications has been observed in recent years. This also concerns xylometazoline, approved for the treatment of allergic rhinitis or upper respiratory tract infections. We present the fatal case of a 40 year-old-woman with a massive hemorrhagic stroke. Initial toxicology tests of biological material collected during autopsy revealed the presence of xylometazoline. No other significant toxicology findings were noted. LC-MS/MS method has been developed to determine xylometazoline concentration, which was 18.6 ng/mL in blood and 498.9 ng/mL in urine. The macroscopically detected hemorrhagic focus was confirmed by histopathological which confirmed hemorrhagic infarcts in the brain tissue, especially in the subarachnoid area. No other pathological changes were found. Based on findings from autopsy and toxicological analyses, the direct cause of death was concluded to be hemorrhagic stroke resulting from xylometazoline intoxication. Although xylometazoline products are regarded as relatively safe and are available over the counter, the risk of adverse effects, in particular stroke leading to death, should be considered. If adverse effects are observed, it is reasonable to measure the concentration of the drug in blood and urine. With such data, it will be possible to assess the actual exposure to this xenobiotic and draw firmer conclusions.

Novel nasal formulation of xylometazoline with hyaluronic acid: In vitro ciliary beat frequency study.

Acute viral rhinosinusitis (viral ARS), or commonly referred to as the "common cold", is caused by respiratory viruses that cause disruption of the airway epithelial barrier and mucociliary dysfunction. Treatment of ARS is mainly symptomatic, with xylometazoline, a direct-acting α-adrenoceptor agonist, commonly used as a nasal decongestant. Unfortunately, this treatment does not resolve the epithelial dysfunction observed in ARS, and its use might negatively impact the nasal mucosa causing issues such as dryness, stinging, burning, rebound congestion, as well as atrophy. In light of this, a novel nasal spray formulation containing both xylometazoline and hyaluronic acid (HA) was developed to provide a more effective and safer treatment for viral ARS. HA is a natural polysaccharide known to hydrate and moisturise the upper respiratory tract, maintain the integrity of the nasal mucosa, and promote mucociliary clearance and wound healing. To investigate the potential of this combination, this study was conducted using the nasal MucilAirTMin vitro model and high-speed phase-contrast microscopy to examine the effect of xylometazoline and HA on ciliary function by measuring ciliary beat frequency and their cytotoxicity by morphological, histological and ultrastructural analysis. This research is the first to assess the effects of a specific dose and molecular weight of HA as an active pharmaceutical ingredient in nasal spray formulations. The combination of a fast-acting decongestant and an additional active agent targeting nasal epithelial dysfunction has the potential to provide an improved, reliable and safe treatment for viral ARS, and may serve as the basis for future clinical studies.

Exquisite integration of quality-by-design and green analytical approaches for simultaneous determination of xylometazoline and antazoline in eye drops and rabbit aqueous humor, application to stability study.

This work implements a stability indicating HPLC method developed to simultaneously determine xylometazoline (XYLO) and antazoline (ANT) in their binary mixture, rabbit aqueous humor and cited drug's degradates by applying analytical quality-by-design (AQbD) combined with green analytical chemistry (GAC) experiment for the first time. This integration was designed to maximize efficiency and minimize environmental impacts, as well as energy and solvent consumption. Analytical quality-by-design was applied to achieve our aim starting with evaluation of quality risk and scouting analysis, tracked via five parameters chromatographic screening using Placket-Burman design namely: pH, temperature, organic solvent percentage, flow rate, and wavelength detection. Recognizing the critical method parameters was done followed by optimization employing central composite design and Derringer's desirability toward assess optimum conditions that attained best resolution with satisfactory peak symmetry with short run time. Optimal chromatographic separation was attained by means of an XBridge® C18 (4.6 × 250 mm, 5 µm) column through isocratic elution using a mobile phase consists of phosphate buffer (pH 3.0): ethanol (60:40, by volume) at a 1.6 mL/min flow rate and 230.0 nm UV detection. Linearity acquired over a concentration range of 1.0-100.0 µg/mL and 0.5-100.0 µg/mL for XYLO and ANT, respectively. Furthermore, imperiling cited drugs' stock solutions to stress various conditions and satisfactory peaks of degradation products were obtained indicating that cited drugs are vulnerable to oxidative degradation and basic hydrolysis. Degradates' structures were elucidated using mass spectrometry. Applying various assessment tools; namely: analytical greenness (AGREE), green analytical procedure index (GAPI), analytical eco-scale, and national environmental method index (NEMI), Greenness method's evaluation was applied and proved to be green. In fact, the developed method is established to be perceptive, accurate, and selective to assess cited drugs for routine analysis.

Naphazoline and oxymetazoline are superior to epinephrine in enhancing the cutaneous analgesia of lidocaine in rats.

This study observed the cutaneous analgesic effect of adrenergic agonists when combined with lidocaine. We aimed at the usefulness of four adrenergic agonists and epinephrine as analgesics or as tools to prolong the effect of local anesthetics using a model of cutaneous trunci muscle reflex (pinprick pain) in rats. We showed that subcutaneous four adrenergic agonists and epinephrine, as well as the local anesthetic bupivacaine and lidocaine, developed a concentration-dependent cutaneous analgesia. The rank order of the efficacy of different compounds (ED50 ; median effective dose) was epinephrine [0.013 (0.012-0.014) µmol] > oxymetazoline [0.25 (0.22-0.28) µmol] > naphazoline [0.42 (0.34-0.53) µmol] = bupivacaine [0.43 (0.37-0.50) µmol] > xylometazoline [1.34 (1.25-1.45) µmol] > lidocaine [5.86 (5.11-6.72) µmol] > tetrahydrozoline [6.76 (6.21-7.36) µmol]. The duration of full recovery caused by tetrahydrozoline, oxymetazoline, or xylometazoline was greater (P < 0.01) than that induced via epinephrine, bupivacaine, lidocaine, or naphazoline at equianesthetic doses (ED25 , ED50 , and ED75 ). Co-administration of lidocaine (ED50 ) with four adrenergic agonists or epinephrine enhanced the cutaneous analgesic effect. We observed that four adrenergic agonists and epinephrine induce analgesia by themselves, and such an effect has a longer duration than local anesthetics. Co-administration of lidocaine with the adrenergic agonist enhances the analgesic effect, and the cutaneous analgesic effect of lidocaine plus naphazoline (or oxymetazoline) is greater than that of lidocaine plus epinephrine.

What is the most appropriate hemostatic material during pediatric adenoidectomy? A prospective comparative randomized double-blinded controlled study.

OBJECTIVES: To evaluate the effect of different hemostatic materials used in adenoidectomy operations to improve the quality of life with the most negligible hazardous impact on pediatric health. STUDY DESIGN: a prospective, case-series, randomized, controlled, double-blinded study. SETTING: All adenoidectomy surgeries were performed between September 2016 to December 2019 at tertiary referral institutions. PATIENTS AND METHODS: 519 patients were included in five groups. Adenoidectomy was performed under general anesthesia, with the following hemostatic procedures: adrenaline, tranexamic acid, hydrogen peroxide, xylometazoline, and saline (as a control group). The five groups were compared regarding the intraoperative blood loss, surgery duration, need for more hemostatic steps, postoperative reactionary and secondary bleedings, postoperative pain and halitosis, and one-year outcome. RESULTS: The four procedures were effective in reducing the blood loss by 19.86%, 11.7%, 30.95%, and 18.91%, respectively, in comparison to the control group. The surgical duration was reduced by 27.65%, 17.86%, 48.11%, and 23.88%, respectively. The need for other hemostatic steps was the least in the hydrogen peroxide group. There was no significant difference between the five groups regarding reactionary bleeding, secondary bleeding, one-week pain, one-month pain, one-month halitosis, and one-year complications. On the other side, hydrogen peroxide had the least one-week halitosis and first-day pain among the five groups. Also, it had the least intraoperative blood loss and surgery duration. CONCLUSIONS: Hydrogen peroxide showed to be the best choice to control hemostasis during an adenoidectomy. It can decrease blood loss and surgery duration with less need for other hemostatic steps. It can improve the patient's quality of life without significant postoperative complications. Xylometazoline was studied for the first time as a hemostatic material during adenoidectomy with good satisfying results.

A screen printed methodology optimized by molecular dynamics simulation and Lean Six Sigma for the determination of xylometazoline in the presence of benzalkonium chloride in nasal drops.

A new chemically disposable screen-printed modified electrode with yttrium doped manganese oxide (Mn2O3/Y2O3) nanocomposite at screen printed electrode was mainly constructed to quantify xylometazoline hydrochloride (XMZ). The crystallographic parameters were estimated from the XRD spectrum, suggesting that Mn2O3 of cubic phase with average grain size ∼ 77 nm. The SEM images revealed that Y3+ dopants had improved the surface topology. The findings indicate that morphological features play a vital role in improving the electronic properties of the fabricated electrode. Augmentation of Six Sigma (SS) with molecular dynamics simulation (MD) as a theoretical study was widely adopted to improve the current process as a quality management methodology by measuring the process capability to determine if the process meets the desired specification limits. Process capability is determined through measuring the variability in the process output and comparing these variations with the desired specifications. Also, it assures a robust method specification at a high level of targeted performance and statistical confidence. A greenness assessment procedure utilizing the eco-scale algorism was conducted to prove the greenness of the proposed methodology. Additionally, the proposed sensor presented a high sensitivity over the concentration range (1x10-6-1x10-2 mol L-1) of a detection limit 3.93 × 10-7 mol L-1 with the Nernstian cationic slope of 58.18 ± 0.76 mV decade-1 at 25 ± 1 °C.

Safety of topical administration of nasal decongestants and vasoconstrictors in paediatric nasal surgery - A systematic review.

OBJECTIVES: Topical intranasal decongestants are essential in nasal surgery to improve operative field. There are concerns regarding safety in paediatric population. Data on safety and safe dosage are limited. This systematic review evaluated the literature on safety and dosage of intranasal decongestant in paediatric population. METHODS: We performed a systematic search of PubMed, EMBASE, Cochrane library for relevant articles. Quality assessment was done on included articles. RESULTS: A total of 10 articles were included: five case reports; three observational studies; and two randomised control trials. Decongestants evaluated were phenylephrine, oxymetazoline, epinephrine, xylometazoline, and cocaine. In total, 209 patients were included. Side effects reported included bradycardia, tachycardia and hypertension. These were mostly self-limiting and of no clinical compromise to the patients. A total of 4/209 (1.9%) of patients required treatment for these reported effects. No mortality was reported in the included studies. CONCLUSION: In the paediatric population, the literature suggests that when delivered in a pre-specified, controlled dosage, the haemodynamic effects of phenylephrine, oxymetazoline, xylometazoline are minimal and of no clinical significance. There is scope for further studies to establish safe dosage in the paediatric population given the paucity of current literature.

Observational study investigating Ectoin® Rhinitis Nasal Spray as natural treatment option of acute rhinosinusitis compared to treatment with Xylometazoline.

INTRODUCTION: Symptomatic relief of acute rhinosinusitis is commonly achieved with nasal decongestants. The current observational study investigated the efficacy and safety of treatment of acute rhinosinusitis with Ectoin® Rhinitis Spray compared to or in combination with Xylometazoline-containing decongesting nasal spray. METHODS: Patients with acute rhinosinusitis applied either Ectoin® Rhinitis Spray, Xylometazoline nasal spray or a combination of both products. Rhinosinusitis symptoms were assessed, and nasal oedema and endonasal redness were determined by rhinoscopy. Patient diaries based on the validated SNOT (Sino Nasal Outcome Test) questionnaire evaluated rhinosinusitis parameters over time and influences of the disease on quality of life. Following treatment, investigators and patients judged the efficacy and tolerability. RESULTS: Ectoin® Rhinitis Spray diminished common rhinosinusitis symptoms such as nasal obstruction, nasal secretion, facial pain/headache, and smell/taste impairment. Upon treatment over 7 days, rhinosinusitis sum scores decreased statistically significantly (p < 0.001) by - 64.25%, which was comparable to that achieved with Xylometazoline-containing decongesting nasal spray (- 67.60%). No side effects were observed during treatment with Ectoin® Rhinitis Spray, whereas treatment with Xylometazoline-containing nasal spray resulted in nasal mucosa dryness. Concomitant treatment with both products diminished the development of nasal dryness and required fewer applications of Xylometazoline-containing nasal spray. CONCLUSION: Ectoin® Rhinitis Spray is an effective, natural treatment option for acute rhinosinusitis, which may be used as monotherapy or as add-on treatment with a Xylometazoline-containing nasal spray. The concomitant use of Ectoin® Rhinitis Spray might reduce the needed dose of decongestant nasal spray and counteract bothersome side effects such as dry nasal mucosa. TRIAL REGISTRATION: The current study was registered in the ClinicalTrials.gov database under the identifier: NCT03693976 (date of registration: Oct 3, 2018).

Transnasal Flexible Laryngoscopy Using Different Topical Preparations and Methods of Application-A Randomized Study.

BACKGROUND: The field of laryngology has grown exponentially since the advent of the transnasal flexible laryngoscopy. Flexible laryngoscopy when performed skillfully using the proper technique, facilitates a good view of the hidden areas of the larynx. OBJECTIVE: To compare the effectiveness of the topical agents in providing a more comfortable experience for the patient, allowing the practitioner to advance the endoscope with less friction, pain and discomfort for the patient using 10% lidocaine spray, 2% lidocaine gel, 4% lidocaine with xylometazoline (1:1) soaked pledgets, or aqueous gel. MATERIALS AND METHODS: A prospective randomized single-blinded clinical trial was conducted in a tertiary care teaching hospital in South India where 376 patients were recruited and allocated into four groups based on the topical preparation used. Following endoscopy, each subject filled a questionnaire grading their experience on a visual analogue scale. The clinician also then answered a questionnaire on aspects of the endoscopy performed. RESULTS: The pain score and the ease of performing the procedure among the different groups were comparable. Those in the 10% lidocaine arm experienced significant burning sensation (P = 0.0001). The other variables such as throat pain (P = 0.783), gag reflex (P = 0.318), unpleasant taste (P = 0.092), globus (P = 0.190), swallowing difficulty after the procedure (P = 0.273), difficulty in breathing (P = 0.744) and willingness to have a repeat procedure (P = 0.883) were also comparable. CONCLUSION: Aqueous gel can be used topically during a flexible nasopharyngolaryngoscopy instead of an anesthetic agent alone or one combined with a nasal decongestant.

[The nasal mucosa in the elderly: features, modern approaches to the treatment of inflammatory diseases of the nasal cavity and paranasal sinuses]. / Slizistaya obolochka polosti nosa v pozhilom vozraste: osobennosti, sovremennye podkhody k terapii vospalitel'nykh zabolevanii polosti nosa i okolonosovykh pazukh.

The article analyzes the problems of population aging that are relevant for the world civilization, the peculiarities of changes in the body in old age and senility, in particular, the nasal cavity and paranasal sinuses. The analysis of algorithms of actions of an otorhinolaryngologist when prescribing drugs for the treatment of inflammatory diseases of the nasal cavity and paranasal sinuses in elderly patients is given. The advantages of using a combined nasal spray containing a nasal decongestant of 0.1% xylometazoline and 5% dexpanthenol as a means that improves regeneration and reduces the cytotoxic effect of xylometazoline are reflected. The research of domestic and foreign authors testifying to the rationality of using this combined drug in the practice of an otorhinolaryngologist in the treatment of pathology of the nasal cavity and paranasal sinuses in elderly people is presented.

Topical nasal xylometazoline for flexible bronchoscopy (VAIN): A randomized, double-blind, placebo-controlled trial.

BACKGROUND: The role of topical nasal vasoconstrictor administration during flexible bronchoscopy is unclear. METHODS: Consecutive subjects undergoing flexible bronchoscopy were randomized to receive either topical xylometazoline (0.1%) or placebo (saline nasal spray, 0.74% w/v isotonic solution) before bronchoscopy. Background topical anesthesia included 2% nasal lignocaine gel, pharyngeal spray of 10% lignocaine, and 1% lignocaine solution for spray-as-you-go administration. The primary outcome was the operator rated ease of nasal negotiation of the bronchoscope on the visual analog scale (Negotiation VAS). Secondary objectives included assistant rated facial pain scale score, patient-rated nasal pain score (Pain VAS), time to reach the vocal cords after bronchoscope insertion, operator rated nasal mucosal trauma score (Trauma VAS), hemodynamic changes, and complications between the groups. RESULTS: In all, 148 subjects were recruited and randomized to the placebo (73) and xylometazoline groups (75). Operator rated ease of nasal bronchoscope negotiation (Negotiation VAS) was similar in both the groups [Median (IQR), 1 (1-2) in both groups, p = 0.79]. There were no differences in the other outcomes including assistant rated score of facial pain [(Median (IQR), 2 (2-4) placebo and 2 (2-4) xylometazoline, p = 0.36], Pain VAS [Median (IQR), placebo 2 (1-2) and xylometazoline 2 (1-3), p = 0.28], Trauma VAS, [Median (IQR), placebo 1 (0-2) and xylometazoline 1 (0-1), p = 0.28], hemodynamic changes, or complications between the two groups. CONCLUSION: The findings of this study do not support the administration of topical nasal xylometazoline in flexible bronchoscopy. TRIAL REGISTRY: Trial registered on Clinicaltrials.gov, www.clinicaltrials.govNCT03424889, on January 02, 2018.

Use of Paediatric Xylometazoline Nasal Drop is not a Child's Play in Hypertensive Patients on Bisoprolol: A Case Report.

BACKGROUND: Xylometazoline, a sympathomimetic agent, is considered safe in hypertensive patients as a relief measure for nasal congestion with intranasal application. CASE REPORT: In the present case, a 58-year old male patient, having ischemic heart disease, controlled hypertension on telmisartan and bisoprolol, experienced hypertensive urgency in a span of two hours of intranasal administration of the paediatric formulation of xylometazoline. CONCLUSION: The interaction with bisoprolol should be kept in mind while using xylometazoline.

Effect of Hypertonic Saline during Flexible Nasopharyngeal Laryngoscopy: A Double-Blinded, Randomized, Controlled Trial.

OBJECTIVES: Flexible nasopharyngeal laryngoscopy (NPL) is a cost-effective, simple procedure that provides visualization of the nasal airways. However, it involves a number of challenges for both the clinician and the patient. Hypertonic saline nasal wash is used to prevent nasal secretion in acute/chronic sinusitis and after nasal surgery. We aimed to determine the efficacy of hypertonic saline by comparing the clinician's and patients' experiences during NPL. METHODS: This prospective, double-blinded, randomized, controlled study was performed at a tertiary referral university hospital. Two hundred patients were randomly divided into hypertonic saline, lidocaine, xylometazoline, and isotonic saline groups. During NPL, the clinician's experiences in terms of the quality of the field of view and the patients' experiences in terms of pain and discomfort resulting from the 4 premedication drugs were compared. RESULTS: The groups differed significantly in terms of the clinician's field of view, and patients' pain scores and levels of discomfort (P < 0.025). The field of view results were the highest in the hypertonic saline group, and the lowest in the lidocaine group. The pain scores were the lowest in the lidocaine group, whereas they were the highest in the hypertonic saline group. The discomfort scores were the lowest in the xylometazoline group, but the highest in the lidocaine and isotonic saline groups. CONCLUSION: The use of hypertonic saline facilitated the NPL procedure by improving the clinician's field of view. Moreover, intranasal hypertonic saline reduced the patient's discomfort. Intranasal hypertonic saline can be a good alternative to premedication before NPL.

A prospective randomized trial of xylometazoline drops and epinephrine merocele nasal pack for reducing epistaxis during nasotracheal intubation.

BACKGROUND: The most frequent complication of nasotracheal intubation (NTI) is epistaxis. Epinephrine nasal gauze packing has been used conventionally as a pre-treatment for reducing epistaxis, but it carries a disadvantage of pain and anxiety in patients. However, xylometazoline drops are easier to administer and more convenient for patients. We aimed at comparing the effectiveness of xylometazoline drops and epinephrine merocele packing in reducing bleeding and postoperative complications in our population. METHODS: Our study enrolled 120 patients in a double-blind randomized controlled trial. We randomly allocated ASA1 or 2 adult patients into 2 groups: Group X and Group E. Group X received 0.1% xylometazoline nasal drops, and epinephrine (1:10,000) merocele nasal packing was used in Group E. The primary outcome was the incidence of bleeding during NTI; the severity of bleeding, navigability, bleeding during extubation, and postoperative complications were secondary outcomes. We used IBM SPSS and Minitab software for statistical analysis, and P < 0.05 was considered statistically significant. RESULTS: We analyzed the data of 110 patients: 55 in Group X and 55 in Group E. The two groups did not have different bleeding incidence (56.4% vs 60.0%; P = 0.70); however, the incidence of severe bleeding was less with xylometazoline than with epinephrine (3.63% vs 14.54%; P < 0.05). We also observed less bleeding during extubation (38.2% vs 68.5%; P < 0.05) with xylometazoline. Other secondary outcomes were akin to both groups. CONCLUSION: The incidence of severe and post-extubation bleeding was significantly less with xylometazoline. Hence, it may be an effective alternative for reducing the incidence and severity of epistaxis during NTI.

Safety of the use of xylometazoline nasal spray in young children undergoing lacrimal surgery: an observational study.

PURPOSE: It is common practice to prepare the nasal mucosa with decongestant in children undergoing lacrimal surgery. Xylometazoline 0.05% (Otrivine) nasal spray is commonly used. It has been reported to cause cardiovascular side effects. In the absence of formal guidelines on the safety of the use of nasal decongestants in children, we reviewed our practice to answer the question: How safe is preoperative use of xylometazoline in children undergoing lacrimal surgery? To our knowledge, this is the first study to address the potential side effects of the use of xylometazoline preoperatively in children undergoing lacrimal surgery. METHODS: This was a retrospective analysis of medical notes of children undergoing lacrimal surgery with the use of preoperative intranasal xylometazoline 0.05% over a 5-year period. RESULTS: Twenty-nine children, age 1-6 years (mean 3 years), underwent lacrimal surgery under general anesthesia with preoperative use of intranasal xylometazoline. Topical intranasal 1:10,000 adrenaline was used during surgery in all patients. All children were found to have uneventful surgery and recovery from anesthesia. CONCLUSIONS: Xylometazoline 0.05% intranasal use for prelacrimal surgery was found to be effective and safe. Addition of sympathomimetic topical adrenaline (1:10,000) did not impose any risks. The type of general anesthesia may influence the cardiovascular side effects anecdotally recorded during xylometazoline use.

Xylometazoline nasal drops induced anaphylaxis: An atypical perioperative complication.

Xylometazoline nasal drops used for nasal decongestion can have side-effect in the form of palpitation, hypertension, headache, and tremors. Anaphylaxis to xylometazoline nasal drops is a relatively unrecognized complication. We encountered a patient posted for tonsillectomy who developed serious anaphylaxis upon administration of a commercially available preparation of xylometazoline nasal drops and required aggressive management for stabilization. Further evaluation and literature search indicated toward the preservative (benzylalkonium chloride) as the cause of this adverse event.