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o Chronic rhinosinusitis is one of the most common health issue affected American population. Surgery plays an important role in the patients who failed the medical treatment. The most difficult location to be operated endoscopically is the frontal sinus. Frontal sinus is also found to be one of the most common sinus for residual and recurrence after the operation. Intranasal steroid seems to be one of the most beneficent post-sinus surgery cares. The topical therapy can be delivered by many approaches. According to the standard clinical practice guideline and recommendations, intranasal corticosteroid spray is suggested. The technique proved to have greater distribution than standard intranasal spray is instillation of steroid nose drops. The head position for instillation of steroid nose drops proven to have a greater access to olfactory cleft and frontal area is Vertex-to-floor position.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide nasal instillation | Experimental | budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily |
|
| Normal saline nasal instillation | Placebo Comparator | Normal saline solution instilled in vertex to floor position daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide nasal instillation | Drug |
| ||
| Normal saline nasal instillation |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sinonasal outcome test (SNOT) 20 score (validated Thai version) | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES) | three months | |
| Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version) | three months |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Bangkok | Bangkok | 10330 | Thailand | ||
| Srinagarind Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23883597 | Result | Halawi AM, Smith SS, Chandra RK. Chronic rhinosinusitis: epidemiology and cost. Allergy Asthma Proc. 2013 Jul-Aug;34(4):328-334. doi: 10.2500/aap.2013.34.3675. | |
| 24819891 | Result | Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161. |
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| Drug |
|
| Khon Kaen |
| Changwat Khon Kaen |
| 40002 |
| Thailand |
| 21859049 | Result | Bhattacharyya N. Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States. Ann Otol Rhinol Laryngol. 2011 Jul;120(7):423-7. doi: 10.1177/000348941112000701. |
| 22469599 | Result | Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000. |
| 18641522 | Result | Grobler A, Weitzel EK, Buele A, Jardeleza C, Cheong YC, Field J, Wormald PJ. Pre- and postoperative sinus penetration of nasal irrigation. Laryngoscope. 2008 Nov;118(11):2078-81. doi: 10.1097/MLG.0b013e31818208c1. |
| 15547811 | Result | Musy PY, Kountakis SE. Anatomic findings in patients undergoing revision endoscopic sinus surgery. Am J Otolaryngol. 2004 Nov-Dec;25(6):418-22. doi: 10.1016/j.amjoto.2004.06.002. |
| 18585576 | Result | Harvey RJ, Goddard JC, Wise SK, Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation. Otolaryngol Head Neck Surg. 2008 Jul;139(1):137-42. doi: 10.1016/j.otohns.2008.04.020. |
| 14755189 | Result | Miller TR, Muntz HR, Gilbert ME, Orlandi RR. Comparison of topical medication delivery systems after sinus surgery. Laryngoscope. 2004 Feb;114(2):201-4. doi: 10.1097/00005537-200402000-00004. |
| 19932850 | Result | Harvey RJ, Debnath N, Srubiski A, Bleier B, Schlosser RJ. Fluid residuals and drug exposure in nasal irrigation. Otolaryngol Head Neck Surg. 2009 Dec;141(6):757-61. doi: 10.1016/j.otohns.2009.09.006. |
| 2862235 | Result | Hardy JG, Lee SW, Wilson CG. Intranasal drug delivery by spray and drops. J Pharm Pharmacol. 1985 May;37(5):294-7. doi: 10.1111/j.2042-7158.1985.tb05069.x. |
| 973982 | Result | Aoki FY, Crowley JC. Distribution and removal of human serum albumin-technetium 99m instilled intranasally. Br J Clin Pharmacol. 1976 Oct;3(5):869-78. doi: 10.1111/j.1365-2125.1976.tb00640.x. |
| 19793277 | Result | Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x. |
| 24618629 | Result | Snidvongs K, Dalgorf D, Kalish L, Sacks R, Pratt E, Harvey RJ. Modified Lund Mackay Postoperative Endoscopy Score for defining inflammatory burden in chronic rhinosinusitis. Rhinology. 2014 Mar;52(1):53-59. doi: 10.4193/Rhino13.056. |