Cyclopentolate-Induced Systemic Complications in a Pediatric Patient: A Case Report

Cyclopentolate-Induced Systemic Complications in a Pediatric Patient: A Case Report | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Case Report Cyclopentolate-Induced Systemic Complications in a Pediatric Patient: A Case Report Moti Dejene, Kumale Tolesa This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6465770/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Cyclopentolate hydrochloride is commonly used for cycloplegic refraction in pediatric patients. Although considered safe, rare systemic side effects, particularly involving the central nervous system (CNS), can occur. We report a case of a 5-year-old boy who developed acute CNS symptoms including hallucinations, hyperactivity, disorientation, and inability to maintain balance after receiving routine cycloplegic refraction with cyclopentolate 1% administered at standard dosing intervals. Supportive treatment and intravenous diazepam were administered, and the patient made a full recovery within six hours. Clinicians must remain vigilant for systemic toxicity of cyclopentolate, particularly in pediatric patients. Early recognition and prompt management are crucial for favorable outcomes. Cyclopentolate pediatric ophthalmology systemic toxicity cycloplegia adverse effects Introduction Cyclopentolate is a commonly used cycloplegic agent in pediatric ophthalmology. Its primary indication is to induce cycloplegia for accurate refractive assessment and to treat various ocular conditions such as accommodative esotropia and amblyopia. Cyclopentolate is a short-acting antimuscarinic agent that works by blocking the effects of acetylcholine on the ciliary muscle and the sphincter muscle of the iris, resulting in pupil dilation and paralysis of accommodation ( 1 ). The drug is available in concentrations ranging from 0.5–2%, with higher concentrations typically used in younger patients to achieve adequate cycloplegia. Cyclopentolate is preferred in clinical settings because of its fast onset and relatively short duration of action, generally lasting between 4 to 6 hours ( 2 ). While cyclopentolate is widely regarded as safe and effective, it is not without its risks, especially in children. Pediatric patients are particularly susceptible to the systemic side effects of cyclopentolate due to their smaller body mass, underdeveloped blood-brain barrier, and higher surface area-to-body weight ratio ( 3 ). This population also exhibits a higher incidence of adverse reactions such as tachycardia, dry mouth, urinary retention, and behavioral disturbances, including confusion, agitation, and hallucinations ( 4 ). These reactions are primarily due to the drug’s systemic anticholinergic properties, which can result in toxicity when absorbed in excess ( 5 ). The occurrence of cyclopentolate toxicity is relatively rare but can be severe, leading to significant morbidity. Symptoms of systemic toxicity typically begin 20 to 30 minutes after administration and may include central nervous system effects such as sedation, delirium, and hallucinations. Other manifestations may include fever, tachycardia, dry skin, and difficulty urinating ( 6 ). Because of these potential risks, appropriate dosing, careful monitoring, and patient selection are critical to minimizing adverse effects ( 7 ). This case report presents the occurrence of systemic toxicity in a 5-year-old male patient following the administration of cyclopentolate for cycloplegic refraction. We aim to highlight the signs of toxicity, the management approach, and the importance of preventative measures when using cycloplegic agents in pediatric populations. Purpose To present a rare but significant systemic complication due to cyclopentolate in a child and to increase awareness of the need for careful monitoring after its administration. Case presentation A 5-year-old male patient presented to the clinic with a one-week history of redness and tearing in the left eye, accompanied by a scanty mucoid discharge. There was no significant history of medication allergies. On examination, visual acuity was 0.4 in both eyes, and motility was normal in all directions. Intraocular pressure (IOP) was firm in both eyes, and the eyelids showed mild crustation with mild conjunctival injection. The cornea was clear, and the anterior chamber was deep with no cells or flare. The iris and pupils were round, regular, and reactive to light. The lens was transparent. The patient was diagnosed with blepharoconjunctivitis, and a plan was made to initiate treatment with gentamycin eye drops every 4 hours, alongside hygiene advice, and a follow-up was scheduled after three days for cycloplegic refraction. During the follow-up, cycloplegic refraction was performed using cyclopentolate, with three administrations of 1% cyclopentolate every 15 minutes. The refraction results showed a right eye (OD) prescription of + 1.50, -1.00 *5 and a left eye (OS) prescription of + 1.00, -0.50 *155. However, approximately 40–60 minutes after the final administration of cyclopentolate, the patient began exhibiting symptoms of systemic toxicity, including hallucinations, inability to stand independently, inability to recognize people, hyperactivity, and incoherent speech. Vital signs remained stable except pulse rate which was 132 beats per minute, but neurologic assessment revealed altered mental status with a Glasgow Coma Scale score of 14/15. Oxygen saturation was 96% without Oxygen. Cyclopentolate-induced CNS toxicity was suspected, and the patient was admitted for observation and treatment. The patient was put on maintenance Fluids of 400 ml of 1/3 Normal Saline + 2/3 Dextrose 10% over 8 hours. Following supportive management and administration of intravenous diazepam at 0.3 mg/kg, the patient's CNS symptoms gradually resolved. Monitoring of Oxygen saturation and pulse rate over 6 hours showed no further deterioration and full recovery occurred without any residual effects. The child was discharged the next day in stable condition. Discussion Cycloplegic agents such as cyclopentolate, an antimuscarinic agent, are frequently used in pediatric ophthalmology to facilitate accurate refractive assessment. The drug’s effectiveness is due to its ability to block acetylcholine receptors in the iris and ciliary body, leading to pupil dilation and accommodation paralysis. While generally considered safe, cyclopentolate can cause systemic side effects, especially in young children due to their lower body mass, immature blood-brain barrier, and increased sensitivity to anticholinergic drugs ( 2 , 8 ). The patient in this case developed symptoms of central nervous system (CNS) toxicity—hallucinations, disorientation, hyperactivity, and speech incoherence—approximately 40 minutes after administration of three doses of 1% cyclopentolate at 15-minute intervals. These symptoms are consistent with those previously reported in the literature as cyclopentolate-induced anticholinergic syndrome ( 3 ). CNS manifestations may include ataxia, agitation, psychosis, incoherence, and seizures, particularly when high doses are administered or the drug is absorbed systemically through the nasolacrimal duct ( 4 ). Cyclopentolate shares structural and pharmacologic similarities with atropine, but is known to cause more vivid CNS symptoms ( 9 ). Systemic absorption is facilitated in children due to thinner conjunctiva and greater surface area-to-body weight ratio. Moreover, occlusion of the nasolacrimal duct is often neglected during instillation, further increasing systemic uptake ( 6 ). The literature reports several similar cases. For instance, a 6-year-old child developed confusion, agitation, and visual hallucinations after cyclopentolate administration and required hospitalization ( 10 ). Another study from the Armed Forces Medical Journal of India described CNS excitation and altered sensorium following cyclopentolate use, highlighting the importance of dosage control and awareness among clinicians ( 11 ). Management of cyclopentolate toxicity is mainly supportive. Benzodiazepines like diazepam are frequently used to manage agitation and prevent injury, as was done in our patient ( 12 ). In severe cases with persistent CNS symptoms, Physostigmine, a cholinesterase inhibitor that crosses the blood-brain barrier, may be used as a specific antidote. However, due to the potential for severe side effects, its use should be limited to refractory cases under close monitoring ( 13 ). Preventive strategies include limiting the dosage, using the lowest effective concentration, applying pressure to the lacrimal sac post-instillation (punctal occlusion), and close monitoring of young patients after administration. Informed consent and counseling regarding potential side effects are essential, especially when multiple drops are required ( 7 ). In our case, prompt recognition and management led to a full recovery. This case underlines the importance of vigilance when using cycloplegic agents in pediatric patients and the need for clear institutional protocols for their safe administration. It also emphasizes the role of timely identification and supportive management of adverse drug reactions to prevent long-term sequelae. Limitations This case report describes a single patient, and therefore, the findings may not be generalizable. Cyclopentolate serum levels were not measured due to the unavailability of laboratory facilities, and other potential causes of altered mental status were not comprehensively excluded. Furthermore, the effectiveness of the treatment approach cannot be conclusively determined from this isolated observation. Conclusion Cyclopentolate-induced systemic toxicity is a rare but serious complication, particularly in pediatric patients. This case underscores the need for careful monitoring after the administration of cyclopentolate, as well as the importance of recognizing the symptoms of toxicity early to initiate appropriate management. Clinicians should be aware of the potential adverse effects of cyclopentolate and use this agent judiciously, especially in younger populations. Declarations Ethics approval and consent to participate This case report was reviewed and approved by the Institutional Review Board (IRB) of Jimma University. Written informed consent was obtained from the patient’s legal guardian for participation and publication. Consent for publication Written informed consent for publication of the clinical details was obtained from the patient’s legal guardian. Availability of data and materials All relevant data supporting the findings of this case report are included within the article. Additional information is available from the corresponding author upon reasonable request. Competing interests The authors declare that they have no competing interests. Funding No funding was received for this case report preparation and publication. Conflict of Interest: None declared Authors' contributions All authors participated in the patient management. KT contributed to the conceptualization and preparation of the manuscript. MD contributed to data collection and manuscript preparation. All authors reviewed and approved the final version of the manuscript. Acknowledgments We would like to thank the Department of Ophthalmology at Jimma University for their clinical and academic support. We would like to acknowledge the staff of the Department of Ophthalmology at Jimma University for their dedicated care and management of the patient presented in this case report. Their commitment and expertise were instrumental in the successful outcome. Authors' information (optional) KT is a Pediatric Ophthalmologist and Associate Professor of Ophthalmology at Jimma University. MD is a fourth-year Ophthalmology resident at Jimma University. References Osher RH, Holmes JM. Cycloplegic refraction: Overview and practical considerations. Pediatr Ophthalmol Strabismus. 2010;47(2):123–9. Eustis HS, Chamberlain WA. Central nervous system manifestations after cyclopentolate use. Arch Ophthalmol. 1981;99(7):1212–3. Turtz AI, Meleth PM. Toxic psychosis from cyclopentolate hydrochloride. JAMA. 1977;237(13):1357–8. Galvis V, Tello A, Parra MM, et al. Cycloplegic agents: indications and side effects. Colomb Med (Cali). 2014;45(1):28–35. Day SH, MacKinnon J. Acute psychotic reaction to topical cyclopentolate: case report and review. Can J Ophthalmol. 1986;21(4):144–7. Duane’s Ophthalmology. Anticholinergic Cycloplegic Agents. 2012 Edition. American Academy of Ophthalmology. Pediatric Ophthalmology and Strabismus. Basic and Clinical Science Course (BCSC), 2023. Tasneem I, Lamba PA. Cyclopentolate hydrochloride toxicity. Med J Armed Forces India. 2010;66(3):288–9. 10.1016/S0377-1237(10)80069-3 . Stidham DB, Younge BR. Cyclopentolate toxicity in children. Am J Ophthalmol. 1981;92(6):694–7. Fraunfelder FW, Scafidi AF. Possible adverse effects from topical ophthalmic drugs in children. J Am Assoc Pediatr Ophthalmol Strabismus. 2004;8(6):392–6. Tripathi S, Mahajan D. Cyclopentolate toxicity: a rare presentation. Med J Armed Forces India. 2010;66(3):288–9. 10.1016/S0377-1237(10)80069-3 . Craig JP, Tucker T, Mulvihill A. Cyclopentolate toxicity in children: case report and review. Br J Ophthalmol. 2001;85(4):451–3. Westfall TC, Westfall DP. Adrenergic agonists and antagonists. In: Brunton LL, Chabner BA, Knollmann BC, editors. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 12th ed. New York, NY: McGraw-Hill; 2011. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6465770","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Case Report","associatedPublications":[],"authors":[{"id":474725363,"identity":"81a3ef36-33cc-46a4-bca4-36c8e6c44586","order_by":0,"name":"Moti Dejene","email":"","orcid":"","institution":"Jimma University","correspondingAuthor":false,"prefix":"","firstName":"Moti","middleName":"","lastName":"Dejene","suffix":""},{"id":474725364,"identity":"425c3463-6710-4f59-b68f-b135ee978cf9","order_by":1,"name":"Kumale Tolesa","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAElEQVRIiWNgGAWjYBACCRDxAESwg4gKNhBpQFhLAohmBrHOwLXg1oaqhbGNgbAWyRnZiQ8SKhjq+JmZD3/4OY8vsYG9eZsEQ8UfnFqkJXI3GyScYZCQbGZLk+zdxpbYwHOsTILhDG5b5CRyt0kktjFIGBzmMWPgBWmRyDGTYGzDq2X7j8R/IC38nz/+nQPUIv8GqOUfbi1Ah21jSGwA28IgzdsAsoUHqKUBj/d73m6WSDgmITmzmc1MWuYYm3EbT1qxRcIxY5xaJI7nbvzwocaGn5+9+fHHNzXHZPvZD2+88aFGDqcWmE4Y4xgDODITCGlAAjUkqB0Fo2AUjIKRAgBQYEl9d3eK6QAAAABJRU5ErkJggg==","orcid":"","institution":"Jimma University","correspondingAuthor":true,"prefix":"","firstName":"Kumale","middleName":"","lastName":"Tolesa","suffix":""}],"badges":[],"createdAt":"2025-04-16 18:08:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6465770/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6465770/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":87172113,"identity":"b9e4add5-02df-4347-8b1d-1f6984c5520f","added_by":"auto","created_at":"2025-07-21 07:39:23","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":323628,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6465770/v1/090aea78-94b9-43bc-87ec-eb0defbba47f.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Cyclopentolate-Induced Systemic Complications in a Pediatric Patient: A Case Report","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCyclopentolate is a commonly used cycloplegic agent in pediatric ophthalmology. Its primary indication is to induce cycloplegia for accurate refractive assessment and to treat various ocular conditions such as accommodative esotropia and amblyopia. Cyclopentolate is a short-acting antimuscarinic agent that works by blocking the effects of acetylcholine on the ciliary muscle and the sphincter muscle of the iris, resulting in pupil dilation and paralysis of accommodation (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). The drug is available in concentrations ranging from 0.5\u0026ndash;2%, with higher concentrations typically used in younger patients to achieve adequate cycloplegia. Cyclopentolate is preferred in clinical settings because of its fast onset and relatively short duration of action, generally lasting between 4 to 6 hours (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eWhile cyclopentolate is widely regarded as safe and effective, it is not without its risks, especially in children. Pediatric patients are particularly susceptible to the systemic side effects of cyclopentolate due to their smaller body mass, underdeveloped blood-brain barrier, and higher surface area-to-body weight ratio (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). This population also exhibits a higher incidence of adverse reactions such as tachycardia, dry mouth, urinary retention, and behavioral disturbances, including confusion, agitation, and hallucinations (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). These reactions are primarily due to the drug\u0026rsquo;s systemic anticholinergic properties, which can result in toxicity when absorbed in excess (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe occurrence of cyclopentolate toxicity is relatively rare but can be severe, leading to significant morbidity. Symptoms of systemic toxicity typically begin 20 to 30 minutes after administration and may include central nervous system effects such as sedation, delirium, and hallucinations. Other manifestations may include fever, tachycardia, dry skin, and difficulty urinating (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Because of these potential risks, appropriate dosing, careful monitoring, and patient selection are critical to minimizing adverse effects (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThis case report presents the occurrence of systemic toxicity in a 5-year-old male patient following the administration of cyclopentolate for cycloplegic refraction. We aim to highlight the signs of toxicity, the management approach, and the importance of preventative measures when using cycloplegic agents in pediatric populations.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003ePurpose\u003c/strong\u003e \u003cp\u003eTo present a rare but significant systemic complication due to cyclopentolate in a child and to increase awareness of the need for careful monitoring after its administration.\u003c/p\u003e \u003c/p\u003e"},{"header":"Case presentation","content":"\u003cp\u003eA 5-year-old male patient presented to the clinic with a one-week history of redness and tearing in the left eye, accompanied by a scanty mucoid discharge. There was no significant history of medication allergies. On examination, visual acuity was 0.4 in both eyes, and motility was normal in all directions. Intraocular pressure (IOP) was firm in both eyes, and the eyelids showed mild crustation with mild conjunctival injection. The cornea was clear, and the anterior chamber was deep with no cells or flare. The iris and pupils were round, regular, and reactive to light. The lens was transparent. The patient was diagnosed with blepharoconjunctivitis, and a plan was made to initiate treatment with gentamycin eye drops every 4 hours, alongside hygiene advice, and a follow-up was scheduled after three days for cycloplegic refraction. During the follow-up, cycloplegic refraction was performed using cyclopentolate, with three administrations of 1% cyclopentolate every 15 minutes. The refraction results showed a right eye (OD) prescription of +\u0026thinsp;1.50, -1.00 *5 and a left eye (OS) prescription of +\u0026thinsp;1.00, -0.50 *155. However, approximately 40\u0026ndash;60 minutes after the final administration of cyclopentolate, the patient began exhibiting symptoms of systemic toxicity, including hallucinations, inability to stand independently, inability to recognize people, hyperactivity, and incoherent speech.\u003c/p\u003e \u003cp\u003eVital signs remained stable except pulse rate which was 132 beats per minute, but neurologic assessment revealed altered mental status with a Glasgow Coma Scale score of 14/15. Oxygen saturation was 96% without Oxygen. Cyclopentolate-induced CNS toxicity was suspected, and the patient was admitted for observation and treatment. The patient was put on maintenance Fluids of 400 ml of 1/3 Normal Saline\u0026thinsp;+\u0026thinsp;2/3 Dextrose 10% over 8 hours.\u003c/p\u003e \u003cp\u003eFollowing supportive management and administration of intravenous diazepam at 0.3 mg/kg, the patient's CNS symptoms gradually resolved. Monitoring of Oxygen saturation and pulse rate over 6 hours showed no further deterioration and full recovery occurred without any residual effects. The child was discharged the next day in stable condition.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eCycloplegic agents such as cyclopentolate, an antimuscarinic agent, are frequently used in pediatric ophthalmology to facilitate accurate refractive assessment. The drug\u0026rsquo;s effectiveness is due to its ability to block acetylcholine receptors in the iris and ciliary body, leading to pupil dilation and accommodation paralysis. While generally considered safe, cyclopentolate can cause systemic side effects, especially in young children due to their lower body mass, immature blood-brain barrier, and increased sensitivity to anticholinergic drugs (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe patient in this case developed symptoms of central nervous system (CNS) toxicity\u0026mdash;hallucinations, disorientation, hyperactivity, and speech incoherence\u0026mdash;approximately 40 minutes after administration of three doses of 1% cyclopentolate at 15-minute intervals. These symptoms are consistent with those previously reported in the literature as cyclopentolate-induced anticholinergic syndrome (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). CNS manifestations may include ataxia, agitation, psychosis, incoherence, and seizures, particularly when high doses are administered or the drug is absorbed systemically through the nasolacrimal duct (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eCyclopentolate shares structural and pharmacologic similarities with atropine, but is known to cause more vivid CNS symptoms (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Systemic absorption is facilitated in children due to thinner conjunctiva and greater surface area-to-body weight ratio. Moreover, occlusion of the nasolacrimal duct is often neglected during instillation, further increasing systemic uptake (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe literature reports several similar cases. For instance, a 6-year-old child developed confusion, agitation, and visual hallucinations after cyclopentolate administration and required hospitalization (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Another study from the Armed Forces Medical Journal of India described CNS excitation and altered sensorium following cyclopentolate use, highlighting the importance of dosage control and awareness among clinicians (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eManagement of cyclopentolate toxicity is mainly supportive. Benzodiazepines like diazepam are frequently used to manage agitation and prevent injury, as was done in our patient (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). In severe cases with persistent CNS symptoms, Physostigmine, a cholinesterase inhibitor that crosses the blood-brain barrier, may be used as a specific antidote. However, due to the potential for severe side effects, its use should be limited to refractory cases under close monitoring (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e).\u003c/p\u003e \u003cp\u003ePreventive strategies include limiting the dosage, using the lowest effective concentration, applying pressure to the lacrimal sac post-instillation (punctal occlusion), and close monitoring of young patients after administration. Informed consent and counseling regarding potential side effects are essential, especially when multiple drops are required (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn our case, prompt recognition and management led to a full recovery. This case underlines the importance of vigilance when using cycloplegic agents in pediatric patients and the need for clear institutional protocols for their safe administration. It also emphasizes the role of timely identification and supportive management of adverse drug reactions to prevent long-term sequelae.\u003c/p\u003e"},{"header":"Limitations","content":"\u003cp\u003eThis case report describes a single patient, and therefore, the findings may not be generalizable. Cyclopentolate serum levels were not measured due to the unavailability of laboratory facilities, and other potential causes of altered mental status were not comprehensively excluded. Furthermore, the effectiveness of the treatment approach cannot be conclusively determined from this isolated observation.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eCyclopentolate-induced systemic toxicity is a rare but serious complication, particularly in pediatric patients. This case underscores the need for careful monitoring after the administration of cyclopentolate, as well as the importance of recognizing the symptoms of toxicity early to initiate appropriate management. Clinicians should be aware of the potential adverse effects of cyclopentolate and use this agent judiciously, especially in younger populations.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis case report was reviewed and approved by the Institutional Review Board (IRB) of Jimma University. Written informed consent was obtained from the patient\u0026rsquo;s legal guardian for participation and publication.\u003cstrong\u003e\u003cbr\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWritten informed consent for publication of the clinical details was obtained from the patient\u0026rsquo;s legal guardian.\u003cstrong\u003e\u003cbr\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll relevant data supporting the findings of this case report are included within the article. Additional information is available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003cstrong\u003e\u003cbr\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo funding was received for this case report preparation and publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest:\u003c/strong\u003e None declared\u003cstrong\u003e\u003cbr\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors participated in the patient management. KT contributed to the conceptualization and preparation of the manuscript. MD contributed to data collection and manuscript preparation. All authors reviewed and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank the Department of Ophthalmology at Jimma University for their clinical and academic support. We would like to acknowledge the staff of the Department of Ophthalmology at Jimma University for their dedicated care and management of the patient presented in this case report. Their commitment and expertise were instrumental in the successful outcome.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; information (optional)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eKT is a Pediatric Ophthalmologist and Associate Professor of Ophthalmology at Jimma University.\u003cbr\u003e\u0026nbsp;MD is a fourth-year Ophthalmology resident at Jimma University.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eOsher RH, Holmes JM. Cycloplegic refraction: Overview and practical considerations. Pediatr Ophthalmol Strabismus. 2010;47(2):123\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEustis HS, Chamberlain WA. Central nervous system manifestations after cyclopentolate use. Arch Ophthalmol. 1981;99(7):1212\u0026ndash;3.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTurtz AI, Meleth PM. Toxic psychosis from cyclopentolate hydrochloride. JAMA. 1977;237(13):1357\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGalvis V, Tello A, Parra MM, et al. Cycloplegic agents: indications and side effects. Colomb Med (Cali). 2014;45(1):28\u0026ndash;35.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDay SH, MacKinnon J. Acute psychotic reaction to topical cyclopentolate: case report and review. Can J Ophthalmol. 1986;21(4):144\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDuane\u0026rsquo;s Ophthalmology. Anticholinergic Cycloplegic Agents. 2012 Edition.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAmerican Academy of Ophthalmology. Pediatric Ophthalmology and Strabismus. Basic and Clinical Science Course (BCSC), 2023.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTasneem I, Lamba PA. Cyclopentolate hydrochloride toxicity. Med J Armed Forces India. 2010;66(3):288\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/S0377-1237(10)80069-3\u003c/span\u003e\u003cspan address=\"10.1016/S0377-1237(10)80069-3\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStidham DB, Younge BR. Cyclopentolate toxicity in children. Am J Ophthalmol. 1981;92(6):694\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFraunfelder FW, Scafidi AF. Possible adverse effects from topical ophthalmic drugs in children. J Am Assoc Pediatr Ophthalmol Strabismus. 2004;8(6):392\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTripathi S, Mahajan D. Cyclopentolate toxicity: a rare presentation. Med J Armed Forces India. 2010;66(3):288\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/S0377-1237(10)80069-3\u003c/span\u003e\u003cspan address=\"10.1016/S0377-1237(10)80069-3\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCraig JP, Tucker T, Mulvihill A. Cyclopentolate toxicity in children: case report and review. Br J Ophthalmol. 2001;85(4):451\u0026ndash;3.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWestfall TC, Westfall DP. Adrenergic agonists and antagonists. In: Brunton LL, Chabner BA, Knollmann BC, editors. Goodman \u0026amp; Gilman\u0026rsquo;s The Pharmacological Basis of Therapeutics. 12th ed. New York, NY: McGraw-Hill; 2011.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Cyclopentolate, pediatric ophthalmology, systemic toxicity, cycloplegia, adverse effects","lastPublishedDoi":"10.21203/rs.3.rs-6465770/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6465770/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eCyclopentolate hydrochloride is commonly used for cycloplegic refraction in pediatric patients. Although considered safe, rare systemic side effects, particularly involving the central nervous system (CNS), can occur. We report a case of a 5-year-old boy who developed acute CNS symptoms including hallucinations, hyperactivity, disorientation, and inability to maintain balance after receiving routine cycloplegic refraction with cyclopentolate 1% administered at standard dosing intervals. Supportive treatment and intravenous diazepam were administered, and the patient made a full recovery within six hours. Clinicians must remain vigilant for systemic toxicity of cyclopentolate, particularly in pediatric patients. Early recognition and prompt management are crucial for favorable outcomes.\u003c/p\u003e","manuscriptTitle":"Cyclopentolate-Induced Systemic Complications in a Pediatric Patient: A Case Report","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-24 08:36:30","doi":"10.21203/rs.3.rs-6465770/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"402391ce-55bc-4342-99d1-fe55c2068e83","owner":[],"postedDate":"June 24th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-07-21T07:39:13+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-24 08:36:30","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6465770","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6465770","identity":"rs-6465770","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}