A prospective, double-blind, randomized study on the use of a topical anesthetic, vasoconstrictor, and placebo during transnasal flexible fiberoptic endoscopy. Postoperative care for Samter's triad patients undergoing endoscopic sinus surgery: a double-blinded, randomized controlled trial. Is local anaesthesia actually beneficial in flexible fibreoptic nasendoscopy? Sensitivity of a new grading system for studying nasal polyps with the potential to detect early changes in polyp size after treatment with a topical corticosteroid (budesonide). Fluticasone propionate aqueous nasal spray does not influence the recurrence rate of chronic rhinosinusitis and nasal polyps 1 year after functional endoscopic sinus surgery. The use of topical nasal anaesthesia before flexible nasendoscopy: a double-blind, randomized controlled trial comparing cophenylcaine with placebo. Effect of fluticasone in severe polyposis. Infections after endoscopic polypectomy using nasal steroids. Functional endoscopic sinus surgery: 5 year follow up and results of a prospective, randomised, stratified, double-blind, placebo controlled study of postoperative fluticasone propionate aqueous nasal spray.
The purpose of the present study was to compare patient comfort levels following administration of a topical anesthetic, vasoconstrictor, placebo, or nothing to the nasal mucosa prior to flexible fiberoptic transnasal endoscopy. Using a prospective, double-blind, randomized design, 152 consecutive patients were randomly assigned to receive a topical anesthetic (N = 54), vasoconstrictor (N = 50), or placebo (N = 48). No significant differences were found among the three variables. An additional 50 consecutive patients had endoscopy performed without administration of any substance to the nares, and no significant differences were found among the four variables (N = 202). It was concluded that speech-language pathologists can perform independent and comfortable transnasal endoscopy without administration of any substance to the nasal mucosa. Flexible fiberoptic endoscopy, however, should be performed by experienced clinicians with care taken to examine visually the patency of both nares for ease and comfort of scope insertion. Evidence is lacking to guide the postoperative management of Samter's triad patients with chronic rhinosinusitis with polyposis (CRSwP) undergoing endoscopic sinus surgery (ESS). The purpose of this study was to compare three different standardized medication regimens prescribed to these patients after ESS.
                Three-arm, randomized, double-blinded, controlled trial.
                Patients with Samter's triad undergoing ESS were postoperatively randomized into three medication regimens, those being saline irrigation alone (control group A), saline irrigation plus separate budesonide nasal spray (group B), and saline irrigation mixed with budesonide nasal spray (group C). Outcome measures were Sino-Nasal Outcome Test scores, Lund-Mackay computed tomography scores, and Lund-Kennedy endoscopic scores taken at preoperative baseline, and then at 6 months and 1 year postoperatively. Side effect profiles were also measured (adrenocorticotropic hormone blood level ranges and intraocular pressure at the same interval points). Analysis of variance and χ(2) analyses were conducted using a Bonferroni correction method and routine descriptive statistics. Inter- and intragroup comparisons were made.
                Sixty subjects were recruited. All groups were equivalent at baseline in all outcomes. All intragroup analyses showed statistically and clinically significant improvement in disease status as compared to baseline (P < .0167), with a sustained but lessened improvement at 1 year. However, no statistically or clinically significant differences were observed between groups at any time point (P > .05). There was no treatment effect noted.
                In this study, nasal steroids did not confer any additional benefit over saline alone as post-ESS care for the Samter's triad CRSwP patient population.
                Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc. Although the application of a topical local anaesthetic before fibreoptic nasendoscopy is routine practice in many otolaryngological outpatients, the actual benefit to the patient of this procedure remains in doubt. Eighty-two patients were recruited in this double-blind randomized control trial which compared the patients' experiences of fibreoptic nasendoscopy with nasal preparations of Xylocaine (lidocaine), normal saline, and no spray to the nose and throat. A visual analogue scoring system was used to determine scores for the overall unpleasantness of procedure, receiving a spray, and taste of the spray, and pain. This study has shown significantly worse overall experience (P = 0.001) and pain (P = 0.048) scores for Xylocaine spray versus no spray. It is concluded that the routine use of topical local anaesthetics within the nose before routine fibreoptic nasendoscopy is not only of no value, but actually makes the experience worse for the patient. We have previously compared different scoring systems for endoscopic staging of nasal polyps. Of the five methods evaluated, we found that two were better than the others with regard to reproducibility and agreement between physicians. One method was lateral imaging, developed by the authors, and the other was a scoring system developed by Lildholdt et al. The main objective of the present study was to compare the sensitivity of these two methods. Another aim was to study the effect on nasal polyposis of topical nasal corticosteroids over a 2-week period. Patients with bilateral nasal polyposis (n = 100) were randomized to a 2-week treatment with a topical corticosteroid (budesonide aqueous nasal spray: 128 microg b.i.d.) or placebo in a double-blind manner. Nasal symptoms were scored before treatment and after 3, 7 and 14 days of treatment, and the patients underwent nasal endoscopy at clinical visits. Patients treated with active substance had an improvement in their symptoms, an effect already detectable after 3 days of treatment, compared with those who received placebo. In addition, a statistically significant decrease in polyp size could be registered after 14 days using lateral imaging but not with the other scoring system. In conclusion, lateral imaging was more sensitive and could detect effects earlier than the other scoring system and can be recommended for the endoscopic staging of nasal polyps in clinical studies. Local corticosteroids are widely used in the treatment of nasal polyps and chronic rhinosinusitis both before and after nasal surgery. Their efficacy after functional endoscopic sinus surgery (FESS) has not been fully established by placebo-controlled trials.
                This double-blind placebo-controlled randomized study was performed in order to investigate whether fluticasone propionate aqueous nasal spray (FPANS) reduces the recurrence rate of nasal polyps and chronic rhinosinusitis during the first year after FESS.
                The trial looked at 162 patients aged 18 years and older requiring FESS for chronic rhinosinusitis or nasal polyps. After FESS combined with peri-operative systemic corticosteroids, patients were randomized and given FPANS 400 microg b.i.d., FPANS 800 microg b.i.d. or placebo b.i.d. for the duration of 1 year. Patients were withdrawn from the trial (but still included in the study for statistical purposes) if there were recurrent or persistent diseases, defined as progressive regrowth of nasal polyps, recurrent signs and symptoms of chronic sinusitis combined with abnormalities on computed tomography scan and persistent complaints for at least 2 months after FESS.
                A significant reduction of symptoms was seen after FESS. After 1 year, 46 patients had been withdrawn from the trial because of recurrent diseases and 32 patients because of persistent symptoms. No differences in the number of patients withdrawn because of recurrent or persistent diseases were found between the patients treated with FPANS and patients treated with placebo. We were also unable to find a positive effect of FPANS compared with placebo in several subgroups such as patients with nasal polyps, high score at FESS or no previous sinus surgery.
                This placebo-controlled study does not show that treatment with FPANS up to 1 year after FESS had a positive effect compared with placebo. The objective was to evaluate the necessity to use topical nasal anaesthesia before flexible nasendoscopy and to compare its use with placebo. The study was carried out using a double-blind randomized controlled trial, with three treatment arms, at the out-patient department at Raigmore Hospital, Inverness. The participants were 90 patients attending the otolaryngology out-patient department who required flexible nasendoscopy as part of their assessment. Each participant was randomized to one of three groups. Group 1 received cophenylcaine spray, group 2 received a placebo spray, and group 3 received no nasal preparation. Flexible nasendoscopy was carried out via a stated protocol and the patient's diagnosis and findings were discussed in the usual way. After the consultation, the patient filled in a questionnaire marking answers on a visual analogue scale. The main outcome measures were pain and overall unpleasantness of procedure. Patient anxiety and willingness to be examined again in the same way if necessary were also assessed. Ease of examination and quality of view were asked from the operator's perspective. The mean scores on a visual analogue scale showed the main outcome measures to be as follows. Pain score measured 1.7 for cophenylcaine, 2.1 for no spray and 2.2 for placebo. Overall unpleasantness scores were 2.0 for cophenylcaine, 1.9 for no spray and 2.4 for placebo. On a visual analogue scale of 0-10, none of these mean main outcome measures reached levels of significance. It was concluded that the use of cophenylcaine spray before flexible nasendoscopy does not give significant advantages over the use of no nasal preparation. To investigate the effect of intranasal corticosteroids in the treatment of polyps in patients with severe polyposis listed for surgical treatment and to determine the treatment effect on the progression of the disease.
                A double-blind, randomized, parallel-group, placebo-controlled, 12-week study at a single center.
                A tertiary referral center in London, England.
                Thirty-four patients with severe polyposis listed for endoscopic surgical treatment.
                By random allocation, fluticasone propionate aqueous nasal spray (FPANS), 200 microg twice a day; beclomethasone dipropionate aqueous nasal spray, 200 microg twice a day; or placebo nasal spray twice a day was administered. Patients received 2 actuations to each nostril in the morning and in the evening.
                Efficacy end points were the need for polypectomy at the end of treatment, the results of acoustic rhinometry, the polyp score, the peak nasal inspiratory flow rate, and an assessment of symptoms.
                The polyp score was significantly decreased in the FPANS-treated group (P < or = .01). The nasal cavity volume was significantly increased in both the FPANS-treated group and the group receiving beclomethasone compared with placebo (P < or = .01) at the end of treatment. The percentage change in the mean morning peak nasal inspiratory flow rate was greater in the FPANS-treated group, with a significant effect observed at week 2 (P = .01). Nasal blockage was significantly decreased in both active groups compared with the group receiving placebo. No significant difference was observed between the treatment groups in the number of patients requiring polypectomy.
                Fluticasone and beclomethasone aqueous nasal sprays are effective in treating the symptoms of severe nasal polyps. There was some evidence that the group treated with FPANS responded more quickly to intervention and that the magnitude of the response was greater than in the group receiving beclomethasone. Topical nasal steroids such as beclomethasone dipropionate and fluticasone propionate have been widely used in the treatment of rhinitis and polyposis. An increase in infection has occurred with the use of fluticasone propionate after endoscopic polypectomy.
                The purpose of this study was to determine the prevalence of nasal and paranasal infections with the use of topic nasal steroids after endoscopic polypectomy and to compare the recurrence rates of the polyposis.
                We conducted a prospective, comparative, open, experimental, longitudinal study at an academic tertiary referral medical center.
                One hundred sixty-two patients in whom endoscopic polypectomy had been indicated were randomly divided into 3 groups of 54 patients each. The patients from the first group were treated with saline lavage only. Patients from the second group also received fluticasone propionate 400 microg/day in nasal spray after lavage. Patients from the third group received beclomethasone dipropionate 600 microg/day after lavage. The prevalence of infections and recurrence of polyposis was compared in the 3 groups.
                Three patients, 2 in the placebo group and 1 in the beclomethasone group, developed infections during the first 3 months after surgical procedure. The recurrence of polyps in the group without steroids was 44%. In contrast, 15% from the patients treated with fluticasone showed recurrence of polyposis; furthermore, 26% of the patients treated with beclomethasone showed recurrence of polypsosis, with a minimum follow-up of 12 months.
                The use of nasal steroids does not seem to increase the prevalence of infections after endoscopic polypectomy. One hundred nine patients with chronic rhinosinusitis underwent functional endoscopic sinus surgery. Seventy seven patients had polyposis. The population was studied prospectively for 5 years postoperatively. Seventy two patients attended the 5 year follow-up visit. At 1, 2, 3, 4 and 5 years of follow-up all outcome measures except olfactory detection thresholds (visual analogue scores, endoscopic findings, nasal mucociliary clearance times, total nasal volumes) were significantly improved compared to preoperative baseline values. Olfactory detection thresholds were significantly improved at 1 and 2 years postoperation. Patient symptom scores were improved in a greater percentage of patients than more objective outcome measures. Thirty eight patients required a total of 88 postoperative rescue medication courses with prednisolone and antibiotic. Twelve patients failed the study as they required at least 1 rescue medication course a month for 2 consecutive months. We demonstrated an 89% 5 year "survival" rate with regards to the risk of failure. The patients were also entered into a randomised, stratified, prospective, double-blind, placebo controlled study of fluticasone propionate aqueous nasal spray 200 mcg twice daily, commencing 6 weeks after FESS, with a 5 year follow-up. The change in overall visual analogue score was significantly better in the FPANS group at 5 years. The changes in endoscopic oedema and polyp scores and in total nasal volumes were significantly better in the FPANS group at 4 years but not 5 years. Last value carried forward analysis demonstrated that changes in endoscopic polyp score and in total nasal volume was significantly better in the FPANS group at 5 years. Significantly more prednisolone rescue medication courses were prescribed in the placebo group. Of the 12 patients who failed the study, 10 were in the placebo group. This difference nearly achieved significance.
The included studies do not demonstrate any evidence to support the use of topical treatments prior to the use of a fibre-optic nasal endoscope. Some go as far as to suggest that these agents should not be used due to cost and unpleasant side effects. Five studies did not demonstrate any advantage in terms of reducing pain or discomfort when using a topical treatment prior to endoscopy. The absence of demonstrable effect may be due to relatively small patient groups. It is therefore possible that there is a small effect of using these sprays. Further research using standardised reporting methods is needed.