{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T10:03:52Z","timestamp":1775815432785,"version":"3.50.1"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T00:00:00Z","timestamp":1772582400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T00:00:00Z","timestamp":1775779200000},"content-version":"vor","delay-in-days":37,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100004748","name":"Mashhad University of Medical Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004748","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Anesth Analg Crit Care"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>The benefits of Dexmedetomidne in sedation of mechanically ventilated pediatric patients are still challenging. In this study, we compared the efficacy and safety of Dexmedetomidine versus Midazolam for achieving deep sedation in pediatric patients receiving mechanical ventilation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomized clinical trial was conducted across three affiliated hospitals during February 2023 until February 2024. Eligible mechanically ventilated children aged 1\u00a0month to 18\u00a0years were randomized 1:1 to receive either Dexmedetomidine (0.25\u20131 mcg\/kg\/h) or midazolam (1\u20134 mcg\/kg\/min) for sedation, alongside fentanyl analgesia. Sedation was assessed using the Ramsey Sedation Scale and target scores set on 5\u20136. Primary outcomes included success rates in achieving target sedation at the beginning of mechanical ventilation; secondary outcomes encompassed hemodynamic adverse effects (hypotension, bradycardia), follow-up assessment of sedation level of successful patients over the next 6\u00a0h, mortality rate, mean arterial blood pressures and heart rates (HR) changes, mechanical ventilation and PICU stay duration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main results<\/jats:title>\n                    <jats:p>Among 130 eligible patients, 120 were analyzed after exclusions (60 per group). Demographic characteristics were similar between groups. The primary outcome revealed that Dexmedetomidine was less effective than Midazolam in achieving target sedation levels across all ages (p\u2009&lt;\u20090.001). In infants under one year, there was no significant difference in sedation effectiveness between the two medications (P\u2009=\u20090.157). Notably, Dexmedetomidine patients required higher drug doses to maintain sedation over 6\u00a0h, while Midazolam patients experienced fewer adjustments (p\u2009&lt;\u20090.001). Hemodynamic complications were significantly less frequent in the Dexmedetomidine group (3.3% vs. 23.3% for hypotension; p\u2009&lt;\u20090.01). However, the two groups did not differ in terms of MAP and HR changes (P\u2009=\u20090.255; P\u2009=\u20090.063). Mortality, mechanical ventilation duration and length of PICU stay were not different between two groups (P\u2009=\u20090.853; P\u2009=\u20090.076; P\u2009=\u20090.082).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Dexmedetomidine is inferior to Midazolam for deep sedation during mechanical ventilation in children aged 1\u00a0month to 18\u00a0years. However, it can be effective in infants under one year of age. Dexmedetomidine presents a lower risk of hemodynamic side effects compared to Midazolam.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>IRCT20190522043672N3 on February 16, 2023.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s44158-026-00370-2","type":"journal-article","created":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T00:13:41Z","timestamp":1772583221000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of dexmedetomidine versus midazolam for sedation in mechanically ventilated pediatric patients: a randomized clinical trial"],"prefix":"10.1186","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7109-046X","authenticated-orcid":false,"given":"Majid","family":"Sezavar","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9516-5013","authenticated-orcid":false,"given":"Hosein","family":"Akhavan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4107-2057","authenticated-orcid":false,"given":"Gholamreza","family":"Khademi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8420-0485","authenticated-orcid":false,"given":"Maryam","family":"Naseri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4396-2707","authenticated-orcid":false,"given":"Tahereh","family":"Sadeghi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-5046-2745","authenticated-orcid":false,"given":"Atiyeh","family":"Kaveh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2026,3,4]]},"reference":[{"key":"370_CR1","doi-asserted-by":"crossref","unstructured":"William V, Angurana SK. Sedation in critically ill mechanically ventilated children: common though contentious. Journal of Pediatric Critical Care. 2023;10(1):7\u20139. PubMed PMID: 01961613\u2013202310010\u201300004.","DOI":"10.4103\/jpcc.jpcc_91_22"},{"issue":"1","key":"370_CR2","doi-asserted-by":"publisher","DOI":"10.1186\/s43054-023-00191-w","volume":"71","author":"N Shajan","year":"2023","unstructured":"Shajan N, Sharma M, Kaur G (2023) Sedation in pediatric intensive care unit and its impact on outcomes of ventilated children: a prospective observational study. Egypt Pediatr Assoc Gaz 71(1):41","journal-title":"Egypt Pediatr Assoc Gaz"},{"key":"370_CR3","doi-asserted-by":"crossref","unstructured":"RamachandRan R, Pariyarath N, Ponnarmeni S, Jain P, Subramanian M (2020) Prospective observational cohort study on dexmedetomidine and midazolam in mechanically ventilated children. J Clin Diagn Res 14(8):05\u201309","DOI":"10.7860\/JCDR\/2020\/44758.13911"},{"key":"370_CR4","doi-asserted-by":"publisher","DOI":"10.3346\/jkms.2019.34.e21","author":"B Lee","year":"2019","unstructured":"Lee B, Park JD, Choi YH, Han YJ, Suh DI (2019) Efficacy and safety of fentanyl in combination with midazolam in children on mechanical ventilation. J Korean Med Sci. https:\/\/doi.org\/10.3346\/jkms.2019.34.e21","journal-title":"J Korean Med Sci"},{"issue":"3","key":"370_CR5","doi-asserted-by":"publisher","first-page":"63","DOI":"10.15171\/hpr.2017.17","volume":"2","author":"B Najafian","year":"2017","unstructured":"Najafian B, Esmaeili B, Khosravi MH (2017) Comparison of fentanyl and midazolam for the sedation of infants under mechanical ventilation; a randomized clinical trial. Hospital Practices and Research 2(3):63\u201367","journal-title":"Hospital Practices and Research"},{"issue":"1","key":"370_CR6","volume":"2014","author":"GM Pacifici","year":"2014","unstructured":"Pacifici GM (2014) Clinical pharmacology of midazolam in neonates and children: effect of disease\u2014a review. Int J Pediatr 2014(1):309342","journal-title":"Int J Pediatr"},{"key":"370_CR7","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s13643-021-01617-5","volume":"10","author":"A Conway","year":"2021","unstructured":"Conway A, Chang K, Mafeld S, Sutherland J (2021) Midazolam for sedation before procedures in adults and children: a systematic review update. Syst Rev 10:1\u201312","journal-title":"Syst Rev"},{"issue":"7","key":"370_CR8","doi-asserted-by":"publisher","first-page":"1592","DOI":"10.1097\/CCM.0000000000000326","volume":"42","author":"SR Kudchadkar","year":"2014","unstructured":"Kudchadkar SR, Yaster M, Punjabi NM (2014) Sedation, sleep promotion, and delirium screening practices in the care of mechanically ventilated children: a wake-up call for the pediatric critical care community. Crit Care Med 42(7):1592\u20131600","journal-title":"Crit Care Med"},{"key":"370_CR9","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1590\/S0034-70942012000100015","volume":"62","author":"J Afonso","year":"2012","unstructured":"Afonso J, Reis F (2012) Dexmedetomidine: current role in anesthesia and intensive care. Rev Bras Anestesiol 62:125\u2013133","journal-title":"Rev Bras Anestesiol"},{"issue":"8","key":"370_CR10","doi-asserted-by":"publisher","first-page":"862","DOI":"10.1111\/cns.13377","volume":"26","author":"B Lang","year":"2020","unstructured":"Lang B, Zhang L, Zhang W, Lin Y, Fu Y, Chen S (2020) A comparative evaluation of dexmedetomidine and midazolam in pediatric sedation: a meta\u2010analysis of randomized controlled trials with trial sequential analysis. CNS Neurosci Ther 26(8):862\u2013875","journal-title":"CNS Neurosci Ther"},{"key":"370_CR11","first-page":"1015054","volume":"2018","author":"H Elmoutaz Mahmoud","year":"2018","unstructured":"Elmoutaz Mahmoud H, Rashwan DAE (2018) Efficacy of Dexmedetomidine versus Ketofol for Sedation of Postoperative Mechanically Ventilated Patients with Obstructive Sleep Apnea. Crit Care Res Prac 2018:1015054 (PubMed PMID: 29623221)","journal-title":"Crit Care Res Prac"},{"issue":"11","key":"370_CR12","doi-asserted-by":"publisher","first-page":"1151","DOI":"10.1001\/jama.2012.304","volume":"307","author":"SM Jakob","year":"2012","unstructured":"Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ et al (2012) Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA 307(11):1151\u20131160","journal-title":"JAMA"},{"key":"370_CR13","doi-asserted-by":"publisher","first-page":"1481","DOI":"10.2165\/11207190-000000000-00000","volume":"71","author":"SM Hoy","year":"2011","unstructured":"Hoy SM, Keating GM (2011) Dexmedetomidine: a review of its use for sedation in mechanically ventilated patients in an intensive care setting and for procedural sedation. Drugs 71:1481\u20131501","journal-title":"Drugs"},{"issue":"7","key":"370_CR14","doi-asserted-by":"publisher","first-page":"811","DOI":"10.1007\/s00134-022-06712-2","volume":"48","author":"K Lewis","year":"2022","unstructured":"Lewis K, Alshamsi F, Carayannopoulos KL, Granholm A, Piticaru J, Al Duhailib Z et al (2022) Dexmedetomidine vs other sedatives in critically ill mechanically ventilated adults: a systematic review and meta-analysis of randomized trials. Intensive Care Med 48(7):811\u2013840","journal-title":"Intensive Care Med"},{"issue":"11","key":"370_CR15","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0294292","volume":"18","author":"J Wen","year":"2023","unstructured":"Wen J, Ding X, Liu C, Jiang W, Xu Y, Wei X et al (2023) A comparation of dexmedetomidine and midazolam for sedation in patients with mechanical ventilation in ICU: a systematic review and meta-analysis. PLoS ONE 18(11):e0294292","journal-title":"PLoS ONE"},{"issue":"5","key":"370_CR16","doi-asserted-by":"publisher","first-page":"451","DOI":"10.1097\/00007611-200405000-00007","volume":"97","author":"JD Tobias","year":"2004","unstructured":"Tobias JD, Berkenbosch JW (2004) Sedation during mechanical ventilation in infants and children: dexmedetomidine versus midazolam. South Med J 97(5):451\u2013456","journal-title":"South Med J"},{"key":"370_CR17","doi-asserted-by":"crossref","unstructured":"Buck ML. Dexmedetomidine use in pediatric intensive care and procedural sedation. J Pediatr Pharmacol Ther. 2010 Jan;15(1):17\u201329. PubMed PMID: 22477789. Pubmed Central PMCID: Pmc3017406. Epub 2010\/01\/01. eng.","DOI":"10.5863\/1551-6776-15.1.17"},{"key":"370_CR18","doi-asserted-by":"crossref","unstructured":"Chrysostomou C, Di Filippo S, Manrique AM, Schmitt CG, Orr RA, Casta A, et al. Use of dexmedetomidine in children after cardiac and thoracic surgery. Pediatr Crit Care Med. 2006 Mar;7(2):126\u201331. PubMed PMID: 16446599. Epub 2006\/02\/01. eng.","DOI":"10.1097\/01.PCC.0000200967.76996.07"},{"key":"370_CR19","doi-asserted-by":"crossref","unstructured":"Aydogan MS, Korkmaz MF, Ozg\u00fcl U, Erdogan MA, Yucel A, Karaman A, et al. Pain, fentanyl consumption, and delirium in adolescents after scoliosis surgery: dexmedetomidine vs midazolam. Paediatr Anaesth. 2013 May;23(5):446\u201352. PubMed PMID: 23448434. Epub 2013\/03\/02. eng.","DOI":"10.1111\/pan.12128"},{"key":"370_CR20","doi-asserted-by":"publisher","first-page":"117","DOI":"10.1007\/s13312-021-2124-7","volume":"58","author":"KM Gulla","year":"2021","unstructured":"Gulla KM, Sankar J, Jat KR, Kabra SK, Lodha R (2021) Dexmedetomidine vs midazolam for sedation in mechanically ventilated children: a randomized controlled trial. Indian Pediatr 58:117\u2013122","journal-title":"Indian Pediatr"},{"issue":"7","key":"370_CR21","doi-asserted-by":"publisher","first-page":"625","DOI":"10.1097\/PCC.0000000000002350","volume":"21","author":"F Sperotto","year":"2020","unstructured":"Sperotto F, Mondardini MC, Dell\u2019Oste C, Vitale F, Ferrario S, Lapi M et al (2020) Efficacy and safety of dexmedetomidine for prolonged sedation in the PICU: a prospective multicenter study (PROSDEX). Pediatr Crit Care Med 21(7):625\u2013636","journal-title":"Pediatr Crit Care Med"},{"key":"370_CR22","doi-asserted-by":"crossref","unstructured":"Lozano-D\u00edaz D, Valdivielso Serna A, Garrido Palomo R, Arias-Arias \u00c1, T\u00e1rraga L\u00f3pez PJ, Mart\u00ednez Guti\u00e9rrez A. Validation of the Ramsay scale for invasive procedures under deep sedation in pediatrics. Paediatr Anaesth. 2021 Oct;31(10):1097\u2013104. PubMed PMID: 34173295. Epub 2021\/06\/27. eng.","DOI":"10.1111\/pan.14248"},{"issue":"5","key":"370_CR23","doi-asserted-by":"publisher","first-page":"468","DOI":"10.1111\/pan.12587","volume":"25","author":"L Pasin","year":"2015","unstructured":"Pasin L, Febres D, Testa V, Frati E, Borghi G, Landoni G et al (2015) Dexmedetomidine vs midazolam as preanesthetic medication in children: a meta\u2010analysis of randomized controlled trials. Paediatr Anaesth 25(5):468\u2013476","journal-title":"Paediatr Anaesth"},{"issue":"2","key":"370_CR24","doi-asserted-by":"publisher","first-page":"125","DOI":"10.4212\/cjhp.v73i2.2978","volume":"73","author":"D Caldwell","year":"2020","unstructured":"Caldwell D, Wong J, Duffett M (2020) Sedative medications for critically ill children during and after mechanical ventilation: a retrospective observational study. Can J Hosp Pharm 73(2):125","journal-title":"Can J Hosp Pharm"},{"key":"370_CR25","doi-asserted-by":"crossref","unstructured":"O'Kane A, Quinney SK, Kinney E, Bergstrom RF, Tillman EM. A systematic review of dexmedetomidine pharmacology in pediatric patients. Clin Transl Sci. 2024 Dec;17(12):e70020. PubMed PMID: 39644147. Pubmed Central PMCID: PMC11624482. Epub 2024\/12\/07. eng.","DOI":"10.1111\/cts.70020"},{"key":"370_CR26","doi-asserted-by":"crossref","unstructured":"Lee S. Dexmedetomidine: present and future directions. Korean J Anesthesiol. 2019 Aug;72(4):323\u201330. PubMed PMID: 31220910. Pubmed Central PMCID: PMC6676029. Epub 2019\/06\/22. eng.","DOI":"10.4097\/kja.19259"},{"key":"370_CR27","first-page":"561","volume":"32","author":"GM Keating","year":"2012","unstructured":"Keating GM, Hoy SM, Lyseng-Williamson KA (2012) Dexmedetomidine: a guide to its use for sedation in the US. Clin Drug Investig 32:561\u2013567","journal-title":"Clin Drug Investig"},{"key":"370_CR28","doi-asserted-by":"publisher","unstructured":"Georgiev YH, Neunhoeffer F, Kumpf M, Hofbeck M, Saeed D, Michel J et al (2024) Emergency endotracheal intubations at a pediatric intensive care unit\u2014incidence and hemodynamic complications. J Pediatr Intensive Care https:\/\/doi.org\/10.1055\/s-0044-1788918","DOI":"10.1055\/s-0044-1788918"},{"key":"370_CR29","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2023.1016316","volume":"10","author":"S Sood","year":"2023","unstructured":"Sood S, Ganatra HA, Perez Marques F, Langner TR (2023) Complications during mechanical ventilation\u2014a pediatric intensive care perspective. Front Med (Lausanne) 10:1016316","journal-title":"Front Med (Lausanne)"},{"issue":"9","key":"370_CR30","doi-asserted-by":"publisher","first-page":"e731","DOI":"10.1097\/PCC.0000000000002483","volume":"21","author":"SJ Erickson","year":"2020","unstructured":"Erickson SJ, Millar J, Anderson BJ, Festa MS, Straney L, Shehabi Y et al (2020) Dexmedetomidine sedation in mechanically ventilated critically ill children: a pilot randomized controlled trial. Pediatr Crit Care Med 21(9):e731\u2013e739","journal-title":"Pediatr Crit Care Med"},{"key":"370_CR31","doi-asserted-by":"publisher","unstructured":"Lee IK, Lee KH, Han H-j, Kim NJ, Kim K (2024) Efficacy and safety of dexmedetomidine in mechanically ventilated critically ill children: a systematic review and meta-analysis of randomized controlled trials. https:\/\/doi.org\/10.21203\/rs.3.rs-4683655\/v1","DOI":"10.21203\/rs.3.rs-4683655\/v1"}],"container-title":["Journal of Anesthesia, Analgesia and Critical Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s44158-026-00370-2","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s44158-026-00370-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s44158-026-00370-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T09:29:29Z","timestamp":1775813369000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s44158-026-00370-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,4]]},"references-count":31,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["370"],"URL":"https:\/\/doi.org\/10.1186\/s44158-026-00370-2","relation":{},"ISSN":["2731-3786"],"issn-type":[{"value":"2731-3786","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,4]]},"assertion":[{"value":"9 December 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 February 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 March 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethical approval for this study was obtained from the Ethics Committee of Mashhad University of Medical Sciences (Ethics Code: IR.MUMS.MEDICAL.REC.1401.537). All procedures adhered to relevant guidelines and regulations, specifically the Declaration of Helsinki. Informed consent was obtained from parents of all participants prior to their involvement in the study. Parents of the patients were clearly informed about the voluntary nature of their child's participation and their right to withdraw at any point. To maintain confidentiality and privacy, questionnaires were completed anonymously, using unique identifiers for each participant.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"58"}}