Assessing National Trends and Perceived Safety of Off‐Label Ciprofloxacin‐Dexamethasone Use by Pediatric Otolaryngologists
Objectives Off‐label use of Ciprodex® (ciprofloxacin‐dexamethasone: CPD), an antibiotic‐steroid combination solution, in the airway has been reported by pediatric otolaryngologists with anecdotal success. We examined national trends regarding off‐label CPD use including prevalence, common indication...
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| Veröffentlicht in: | The Laryngoscope 2024-06, Vol.134 (6), p.2922-2930 |
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| creator | Shah, Hemali P. Shah, Rema Lockwood, Donovan Yang, Nan Rohrbaugh, Tagan Rutter, Michael J. Maurrasse, Sarah E. |
| description | Objectives
Off‐label use of Ciprodex® (ciprofloxacin‐dexamethasone: CPD), an antibiotic‐steroid combination solution, in the airway has been reported by pediatric otolaryngologists with anecdotal success. We examined national trends regarding off‐label CPD use including prevalence, common indications, prescriber patterns, adverse events, and accessibility.
Methods
15‐item cross‐sectional survey was distributed to American Society of Pediatric Otolaryngology members from January–April 2022. Univariate analyses were performed to compare responses for users of off‐label CPD versus non‐users. Ease of access was compared across geographies and practice types using multivariate logistic regressions.
Results
Of the 163 complete responses (26.6% response rate), 156 (95.7%) reported using off‐label CPD. Most common indications for off‐label CPD were tracheal granulation (87.8%, n = 137) and choanal atresia (82.1%, n = 128). Ease of access was significantly increased in the Midwest (OR:18.79, 95%CI:3.63–1.24, p = 0.001) and West (OR:29.92, 95%CI:3.55–682.00, p = 0.006). Ease of access was significantly lower at tertiary referral centers (OR:0.11, 95%CI:0.01–0.64, p = 0.041) and private practices (OR:0.04, 95%CI:0.002–0.33, p = 0.009) compared to academic free‐standing children's hospitals. Two‐thirds of respondents reported feeling “Very Comfortable” with the safety profile of off‐label CPD; 99.4% (n = 156) felt that the benefits outweighed the risks of off‐label use. Seven respondents (4.5%) reported adverse events (e.g., local allergic reaction, cushingoid symptoms) from off‐label use.
Conclusions
Our findings (26.6% response rate) suggest that off‐label CPD is commonly used by pediatric otolaryngologists, many of whom reported feeling that the benefits of off‐label CPD outweigh the risks. Our results establish a baseline for future efforts to assess the efficacy and safety of off‐label CPD and to improve its accessibility.
Level of Evidence
V Laryngoscope, 134:2922–2930, 2024
Anecdotal success with off‐label use of ciprofloxacin‐dexamethasone, an antibiotic‐steroid combination solution, has been reported in the airway. Our survey found that off‐label ciprofloxacin‐dexamethasone is commonly used by pediatric otolaryngologists. Studies to further assess safety and efficacy are needed. |
| doi_str_mv | 10.1002/lary.31211 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2906774889</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3051916480</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3161-4936c1ad5c3a8c9800088eb6b5941a0138880affeeffe5159c95deb8242434a63</originalsourceid><addsrcrecordid>eNp9kcFuEzEQhi0EoqFw4QGQJS4IKcWzXm_sYxQoIEUEQSvByfJ6x8GVs253NrS5IB6BZ-RJcEjhwIGDZcn-9Gn--Rl7DOIEhKheJDfsTiRUAHfYBJSEaW2Mussm5VNOtao-HbEHRBdCwEwqcZ8dSQ21mYlmwr7NiZAo9mv-zo0x9y7xswH7jrjrO_4eB4_xK3b8ows47ngOfBXCz-8_lq7FxBfxcsgh5RvnY19eX-KN2-D4xVHukZ8T8nZXJF104xA9X415P2y_zimvI430kN0LLhE-ur2P2fnpq7PFm-ly9frtYr6cegnNPo9sPLhOeem0N1oIoTW2TatMDU6A1FoLFwJiOQqU8UZ12OqqrmpZu0Yes2cHbxn3aos02k0kjym5HvOWbGVEM5vVWpuCPv0HvcjboeyFrBQKDDS1FoV6fqD8kIkGDPZyiJuSzYKw-1bsPqj93UqBn9wqt-0Gu7_onxoKAAfgOibc_Udll_MPnw_SX4TGmo0</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3051916480</pqid></control><display><type>article</type><title>Assessing National Trends and Perceived Safety of Off‐Label Ciprofloxacin‐Dexamethasone Use by Pediatric Otolaryngologists</title><source>MEDLINE</source><source>Access via Wiley Online Library</source><creator>Shah, Hemali P. ; Shah, Rema ; Lockwood, Donovan ; Yang, Nan ; Rohrbaugh, Tagan ; Rutter, Michael J. ; Maurrasse, Sarah E.</creator><creatorcontrib>Shah, Hemali P. ; Shah, Rema ; Lockwood, Donovan ; Yang, Nan ; Rohrbaugh, Tagan ; Rutter, Michael J. ; Maurrasse, Sarah E.</creatorcontrib><description>Objectives
Off‐label use of Ciprodex® (ciprofloxacin‐dexamethasone: CPD), an antibiotic‐steroid combination solution, in the airway has been reported by pediatric otolaryngologists with anecdotal success. We examined national trends regarding off‐label CPD use including prevalence, common indications, prescriber patterns, adverse events, and accessibility.
Methods
15‐item cross‐sectional survey was distributed to American Society of Pediatric Otolaryngology members from January–April 2022. Univariate analyses were performed to compare responses for users of off‐label CPD versus non‐users. Ease of access was compared across geographies and practice types using multivariate logistic regressions.
Results
Of the 163 complete responses (26.6% response rate), 156 (95.7%) reported using off‐label CPD. Most common indications for off‐label CPD were tracheal granulation (87.8%, n = 137) and choanal atresia (82.1%, n = 128). Ease of access was significantly increased in the Midwest (OR:18.79, 95%CI:3.63–1.24, p = 0.001) and West (OR:29.92, 95%CI:3.55–682.00, p = 0.006). Ease of access was significantly lower at tertiary referral centers (OR:0.11, 95%CI:0.01–0.64, p = 0.041) and private practices (OR:0.04, 95%CI:0.002–0.33, p = 0.009) compared to academic free‐standing children's hospitals. Two‐thirds of respondents reported feeling “Very Comfortable” with the safety profile of off‐label CPD; 99.4% (n = 156) felt that the benefits outweighed the risks of off‐label use. Seven respondents (4.5%) reported adverse events (e.g., local allergic reaction, cushingoid symptoms) from off‐label use.
Conclusions
Our findings (26.6% response rate) suggest that off‐label CPD is commonly used by pediatric otolaryngologists, many of whom reported feeling that the benefits of off‐label CPD outweigh the risks. Our results establish a baseline for future efforts to assess the efficacy and safety of off‐label CPD and to improve its accessibility.
Level of Evidence
V Laryngoscope, 134:2922–2930, 2024
Anecdotal success with off‐label use of ciprofloxacin‐dexamethasone, an antibiotic‐steroid combination solution, has been reported in the airway. Our survey found that off‐label ciprofloxacin‐dexamethasone is commonly used by pediatric otolaryngologists. Studies to further assess safety and efficacy are needed.</description><identifier>ISSN: 0023-852X</identifier><identifier>EISSN: 1531-4995</identifier><identifier>DOI: 10.1002/lary.31211</identifier><identifier>PMID: 38149706</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject><![CDATA[aerodigestive ; airway surgery ; Anti-Bacterial Agents - administration & dosage ; Anti-Bacterial Agents - adverse effects ; Child ; Ciprodex ; Ciprofloxacin - administration & dosage ; Ciprofloxacin - adverse effects ; Ciprofloxacin - therapeutic use ; Cross-Sectional Studies ; Dexamethasone - administration & dosage ; Dexamethasone - adverse effects ; Dexamethasone - therapeutic use ; Drug Combinations ; Female ; Humans ; Male ; Off-Label Use - statistics & numerical data ; off‐label ; Otolaryngologists - statistics & numerical data ; Otolaryngology ; pediatric ; Pediatrics ; Practice Patterns, Physicians' - statistics & numerical data ; Practice Patterns, Physicians' - trends ; Response rates ; Surveys and Questionnaires ; tracheostomy ; Trends ; United States]]></subject><ispartof>The Laryngoscope, 2024-06, Vol.134 (6), p.2922-2930</ispartof><rights>2023 The American Laryngological, Rhinological and Otological Society, Inc.</rights><rights>2024 The American Laryngological, Rhinological and Otological Society, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3161-4936c1ad5c3a8c9800088eb6b5941a0138880affeeffe5159c95deb8242434a63</cites><orcidid>0000-0003-2740-7516 ; 0000-0003-1677-6439 ; 0000-0003-1522-5109 ; 0000-0001-6788-0979</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Flary.31211$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Flary.31211$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38149706$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shah, Hemali P.</creatorcontrib><creatorcontrib>Shah, Rema</creatorcontrib><creatorcontrib>Lockwood, Donovan</creatorcontrib><creatorcontrib>Yang, Nan</creatorcontrib><creatorcontrib>Rohrbaugh, Tagan</creatorcontrib><creatorcontrib>Rutter, Michael J.</creatorcontrib><creatorcontrib>Maurrasse, Sarah E.</creatorcontrib><title>Assessing National Trends and Perceived Safety of Off‐Label Ciprofloxacin‐Dexamethasone Use by Pediatric Otolaryngologists</title><title>The Laryngoscope</title><addtitle>Laryngoscope</addtitle><description>Objectives
Off‐label use of Ciprodex® (ciprofloxacin‐dexamethasone: CPD), an antibiotic‐steroid combination solution, in the airway has been reported by pediatric otolaryngologists with anecdotal success. We examined national trends regarding off‐label CPD use including prevalence, common indications, prescriber patterns, adverse events, and accessibility.
Methods
15‐item cross‐sectional survey was distributed to American Society of Pediatric Otolaryngology members from January–April 2022. Univariate analyses were performed to compare responses for users of off‐label CPD versus non‐users. Ease of access was compared across geographies and practice types using multivariate logistic regressions.
Results
Of the 163 complete responses (26.6% response rate), 156 (95.7%) reported using off‐label CPD. Most common indications for off‐label CPD were tracheal granulation (87.8%, n = 137) and choanal atresia (82.1%, n = 128). Ease of access was significantly increased in the Midwest (OR:18.79, 95%CI:3.63–1.24, p = 0.001) and West (OR:29.92, 95%CI:3.55–682.00, p = 0.006). Ease of access was significantly lower at tertiary referral centers (OR:0.11, 95%CI:0.01–0.64, p = 0.041) and private practices (OR:0.04, 95%CI:0.002–0.33, p = 0.009) compared to academic free‐standing children's hospitals. Two‐thirds of respondents reported feeling “Very Comfortable” with the safety profile of off‐label CPD; 99.4% (n = 156) felt that the benefits outweighed the risks of off‐label use. Seven respondents (4.5%) reported adverse events (e.g., local allergic reaction, cushingoid symptoms) from off‐label use.
Conclusions
Our findings (26.6% response rate) suggest that off‐label CPD is commonly used by pediatric otolaryngologists, many of whom reported feeling that the benefits of off‐label CPD outweigh the risks. Our results establish a baseline for future efforts to assess the efficacy and safety of off‐label CPD and to improve its accessibility.
Level of Evidence
V Laryngoscope, 134:2922–2930, 2024
Anecdotal success with off‐label use of ciprofloxacin‐dexamethasone, an antibiotic‐steroid combination solution, has been reported in the airway. Our survey found that off‐label ciprofloxacin‐dexamethasone is commonly used by pediatric otolaryngologists. Studies to further assess safety and efficacy are needed.</description><subject>aerodigestive</subject><subject>airway surgery</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Anti-Bacterial Agents - adverse effects</subject><subject>Child</subject><subject>Ciprodex</subject><subject>Ciprofloxacin - administration & dosage</subject><subject>Ciprofloxacin - adverse effects</subject><subject>Ciprofloxacin - therapeutic use</subject><subject>Cross-Sectional Studies</subject><subject>Dexamethasone - administration & dosage</subject><subject>Dexamethasone - adverse effects</subject><subject>Dexamethasone - therapeutic use</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Off-Label Use - statistics & numerical data</subject><subject>off‐label</subject><subject>Otolaryngologists - statistics & numerical data</subject><subject>Otolaryngology</subject><subject>pediatric</subject><subject>Pediatrics</subject><subject>Practice Patterns, Physicians' - statistics & numerical data</subject><subject>Practice Patterns, Physicians' - trends</subject><subject>Response rates</subject><subject>Surveys and Questionnaires</subject><subject>tracheostomy</subject><subject>Trends</subject><subject>United States</subject><issn>0023-852X</issn><issn>1531-4995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kcFuEzEQhi0EoqFw4QGQJS4IKcWzXm_sYxQoIEUEQSvByfJ6x8GVs253NrS5IB6BZ-RJcEjhwIGDZcn-9Gn--Rl7DOIEhKheJDfsTiRUAHfYBJSEaW2Mussm5VNOtao-HbEHRBdCwEwqcZ8dSQ21mYlmwr7NiZAo9mv-zo0x9y7xswH7jrjrO_4eB4_xK3b8ows47ngOfBXCz-8_lq7FxBfxcsgh5RvnY19eX-KN2-D4xVHukZ8T8nZXJF104xA9X415P2y_zimvI430kN0LLhE-ur2P2fnpq7PFm-ly9frtYr6cegnNPo9sPLhOeem0N1oIoTW2TatMDU6A1FoLFwJiOQqU8UZ12OqqrmpZu0Yes2cHbxn3aos02k0kjym5HvOWbGVEM5vVWpuCPv0HvcjboeyFrBQKDDS1FoV6fqD8kIkGDPZyiJuSzYKw-1bsPqj93UqBn9wqt-0Gu7_onxoKAAfgOibc_Udll_MPnw_SX4TGmo0</recordid><startdate>202406</startdate><enddate>202406</enddate><creator>Shah, Hemali P.</creator><creator>Shah, Rema</creator><creator>Lockwood, Donovan</creator><creator>Yang, Nan</creator><creator>Rohrbaugh, Tagan</creator><creator>Rutter, Michael J.</creator><creator>Maurrasse, Sarah E.</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2740-7516</orcidid><orcidid>https://orcid.org/0000-0003-1677-6439</orcidid><orcidid>https://orcid.org/0000-0003-1522-5109</orcidid><orcidid>https://orcid.org/0000-0001-6788-0979</orcidid></search><sort><creationdate>202406</creationdate><title>Assessing National Trends and Perceived Safety of Off‐Label Ciprofloxacin‐Dexamethasone Use by Pediatric Otolaryngologists</title><author>Shah, Hemali P. ; Shah, Rema ; Lockwood, Donovan ; Yang, Nan ; Rohrbaugh, Tagan ; Rutter, Michael J. ; Maurrasse, Sarah E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3161-4936c1ad5c3a8c9800088eb6b5941a0138880affeeffe5159c95deb8242434a63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>aerodigestive</topic><topic>airway surgery</topic><topic>Anti-Bacterial Agents - administration & dosage</topic><topic>Anti-Bacterial Agents - adverse effects</topic><topic>Child</topic><topic>Ciprodex</topic><topic>Ciprofloxacin - administration & dosage</topic><topic>Ciprofloxacin - adverse effects</topic><topic>Ciprofloxacin - therapeutic use</topic><topic>Cross-Sectional Studies</topic><topic>Dexamethasone - administration & dosage</topic><topic>Dexamethasone - adverse effects</topic><topic>Dexamethasone - therapeutic use</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Off-Label Use - statistics & numerical data</topic><topic>off‐label</topic><topic>Otolaryngologists - statistics & numerical data</topic><topic>Otolaryngology</topic><topic>pediatric</topic><topic>Pediatrics</topic><topic>Practice Patterns, Physicians' - statistics & numerical data</topic><topic>Practice Patterns, Physicians' - trends</topic><topic>Response rates</topic><topic>Surveys and Questionnaires</topic><topic>tracheostomy</topic><topic>Trends</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shah, Hemali P.</creatorcontrib><creatorcontrib>Shah, Rema</creatorcontrib><creatorcontrib>Lockwood, Donovan</creatorcontrib><creatorcontrib>Yang, Nan</creatorcontrib><creatorcontrib>Rohrbaugh, Tagan</creatorcontrib><creatorcontrib>Rutter, Michael J.</creatorcontrib><creatorcontrib>Maurrasse, Sarah E.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>The Laryngoscope</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shah, Hemali P.</au><au>Shah, Rema</au><au>Lockwood, Donovan</au><au>Yang, Nan</au><au>Rohrbaugh, Tagan</au><au>Rutter, Michael J.</au><au>Maurrasse, Sarah E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessing National Trends and Perceived Safety of Off‐Label Ciprofloxacin‐Dexamethasone Use by Pediatric Otolaryngologists</atitle><jtitle>The Laryngoscope</jtitle><addtitle>Laryngoscope</addtitle><date>2024-06</date><risdate>2024</risdate><volume>134</volume><issue>6</issue><spage>2922</spage><epage>2930</epage><pages>2922-2930</pages><issn>0023-852X</issn><eissn>1531-4995</eissn><abstract>Objectives
Off‐label use of Ciprodex® (ciprofloxacin‐dexamethasone: CPD), an antibiotic‐steroid combination solution, in the airway has been reported by pediatric otolaryngologists with anecdotal success. We examined national trends regarding off‐label CPD use including prevalence, common indications, prescriber patterns, adverse events, and accessibility.
Methods
15‐item cross‐sectional survey was distributed to American Society of Pediatric Otolaryngology members from January–April 2022. Univariate analyses were performed to compare responses for users of off‐label CPD versus non‐users. Ease of access was compared across geographies and practice types using multivariate logistic regressions.
Results
Of the 163 complete responses (26.6% response rate), 156 (95.7%) reported using off‐label CPD. Most common indications for off‐label CPD were tracheal granulation (87.8%, n = 137) and choanal atresia (82.1%, n = 128). Ease of access was significantly increased in the Midwest (OR:18.79, 95%CI:3.63–1.24, p = 0.001) and West (OR:29.92, 95%CI:3.55–682.00, p = 0.006). Ease of access was significantly lower at tertiary referral centers (OR:0.11, 95%CI:0.01–0.64, p = 0.041) and private practices (OR:0.04, 95%CI:0.002–0.33, p = 0.009) compared to academic free‐standing children's hospitals. Two‐thirds of respondents reported feeling “Very Comfortable” with the safety profile of off‐label CPD; 99.4% (n = 156) felt that the benefits outweighed the risks of off‐label use. Seven respondents (4.5%) reported adverse events (e.g., local allergic reaction, cushingoid symptoms) from off‐label use.
Conclusions
Our findings (26.6% response rate) suggest that off‐label CPD is commonly used by pediatric otolaryngologists, many of whom reported feeling that the benefits of off‐label CPD outweigh the risks. Our results establish a baseline for future efforts to assess the efficacy and safety of off‐label CPD and to improve its accessibility.
Level of Evidence
V Laryngoscope, 134:2922–2930, 2024
Anecdotal success with off‐label use of ciprofloxacin‐dexamethasone, an antibiotic‐steroid combination solution, has been reported in the airway. Our survey found that off‐label ciprofloxacin‐dexamethasone is commonly used by pediatric otolaryngologists. Studies to further assess safety and efficacy are needed.</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>38149706</pmid><doi>10.1002/lary.31211</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-2740-7516</orcidid><orcidid>https://orcid.org/0000-0003-1677-6439</orcidid><orcidid>https://orcid.org/0000-0003-1522-5109</orcidid><orcidid>https://orcid.org/0000-0001-6788-0979</orcidid></addata></record> |
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| subjects | aerodigestive airway surgery Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - adverse effects Child Ciprodex Ciprofloxacin - administration & dosage Ciprofloxacin - adverse effects Ciprofloxacin - therapeutic use Cross-Sectional Studies Dexamethasone - administration & dosage Dexamethasone - adverse effects Dexamethasone - therapeutic use Drug Combinations Female Humans Male Off-Label Use - statistics & numerical data off‐label Otolaryngologists - statistics & numerical data Otolaryngology pediatric Pediatrics Practice Patterns, Physicians' - statistics & numerical data Practice Patterns, Physicians' - trends Response rates Surveys and Questionnaires tracheostomy Trends United States |
| title | Assessing National Trends and Perceived Safety of Off‐Label Ciprofloxacin‐Dexamethasone Use by Pediatric Otolaryngologists |
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