{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T12:33:40Z","timestamp":1769085220039,"version":"3.49.0"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T00:00:00Z","timestamp":1733356800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T00:00:00Z","timestamp":1733356800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The acceptability of a children\u2019s premedication, prior to general anaesthesia (GA), is fundamental to ensuring positive clinical- and patient-reported outcomes. Midazolam, the current standard premedication, is known to have an unfavourable side-effects profile and presents a degree of risk which is accepted due to a need for compliance. Melatonin is a functionally diverse hormone with anxiolytic properties that offer potential benefits over midazolam. Little is currently known about how patients and health professionals view these two different premedications. This research aimed to explore the acceptability of midazolam and melatonin as premedications for anxious children undergoing GA, from the perspective of children, caregivers and health professionals involved in the Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Participants were children recruited to the MAGIC trial, their caregivers and health professionals involved in recruitment to the trial. In total, 37 participants (23 health professionals, 10 caregivers and 4 children) took part in semi-structured interviews relating to the MAGIC trial and acceptability of premedications. Interviews were carried out face-to-face, by telephone or online by a trained qualitative researcher. Interviews were transcribed verbatim and analysed using a framework approach.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The acceptability of midazolam and melatonin is related to six main factors: effectiveness as premedication prior to GA; administration of premedication; experience of recovery; prior experiences of premedication; associations and evidence; and range of options for managing anxiety. Interviews highlighted the trade-offs involved and the relevance of the wider context in which premedications are provided. Barriers and facilitators were identified on the acceptability of premedications more generally.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Future clinical trials evaluating the effectiveness of premedications in children prior to general anaesthesia need to consider that premedication choice is multifactorial. The MAGIC study found that melatonin was less effective at reducing anxiety (pre-operative distress) when compared with the standard of care, midazolam. However, there remains a need for a premedication with a better side effects profile to midazolam. While children, caregivers and health professionals are open to alternatives to midazolam, this is likely to vary by subgroup and will involve trade-offs in terms of benefits.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ISCRCTN <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/doi.org\/10.1186\/ISRCTN18296119\">ISRCTN18296119<\/jats:ext-link>. Registered on 10\/01\/2019.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08611-x","type":"journal-article","created":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T11:55:10Z","timestamp":1733399710000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Acceptability of midazolam and melatonin as premedications for anxious children undergoing general anaesthesia: a qualitative interview study with children, caregivers and health professionals participating in the MAGIC trial"],"prefix":"10.1186","volume":"25","author":[{"given":"Jennifer","family":"Kettle","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Bolt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Deery","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diana","family":"Papaioannou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"Rodd","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie C.","family":"Hyslop","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nikki","family":"Totton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0943-9637","authenticated-orcid":false,"given":"Zoe","family":"Marshman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,12,5]]},"reference":[{"issue":"6","key":"8611_CR1","doi-asserted-by":"publisher","first-page":"1290","DOI":"10.1097\/ALN.0b013e3181c14be5","volume":"111","author":"JM Chorney","year":"2009","unstructured":"Chorney JM, Torrey C, Blount R, McLaren CE, Chen W-P, Kain ZN. Healthcare provider and parent behavior and children\u2019s coping and disress at anaesthesia induction. Anaesthesiology. 2009;111(6):1290\u20136.","journal-title":"Anaesthesiology."},{"issue":"10","key":"8611_CR2","doi-asserted-by":"publisher","first-page":"1495","DOI":"10.1111\/jcpt.13763","volume":"47","author":"C-Q Yang","year":"2022","unstructured":"Yang C-Q, Yu K-H, Huang R-R, Qu S-S, Zhang J-M, Li Y-L. Comparison of different sedatives in children before general anaesthesia for selective surgery: a network meta-analysis. J Clin Pharm Ther. 2022;47(10):1495\u2013505.","journal-title":"J Clin Pharm Ther"},{"issue":"9","key":"8611_CR3","doi-asserted-by":"publisher","first-page":"713","DOI":"10.4103\/ija.IJA_491_19","volume":"63","author":"NM Dave","year":"2019","unstructured":"Dave NM. Premedication and induction of anaesthesia in paediatric patients. Indian J Anasth. 2019;63(9):713\u201320.","journal-title":"Indian J Anasth."},{"key":"8611_CR4","doi-asserted-by":"publisher","first-page":"1315","DOI":"10.1016\/j.joms.2012.01.004","volume":"70","author":"S Maeda","year":"2012","unstructured":"Maeda S, Tomoyasu Y, Higuchi H, Mori T, Egusa M, Miyawaki T. Midazolam is associated with delay in recovery and agitation after ambulatory general anesthesia for dental treatment in patients with disabilities: a retrospective cohort study. J Oral Maxillofac Surg. 2012;70:1315\u201320.","journal-title":"J Oral Maxillofac Surg"},{"issue":"2","key":"8611_CR5","doi-asserted-by":"publisher","first-page":"161","DOI":"10.1111\/acem.13115","volume":"24","author":"D Smith","year":"2017","unstructured":"Smith D, Cheek H, Denson B, Pruitt C. Lidocaine pretreatment reduces the discomfort of intranasal midazolam administration: a randomized, double-blind, placebo-controlled trial. Acad Emerg Med. 2017;24(2):161\u20137.","journal-title":"Acad Emerg Med."},{"issue":"6","key":"8611_CR6","doi-asserted-by":"publisher","first-page":"502","DOI":"10.1053\/crad.2001.0923","volume":"57","author":"K Johnson","year":"2002","unstructured":"Johnson K, Page A, Williams H, Wassemer E, Whitehouse W. The use of melatonin as an alternative to sedation in uncooperative children undergoing an MRI examinsiation. Clin Radiol. 2002;57(6):502\u20136.","journal-title":"Clin Radiol."},{"issue":"7","key":"8611_CR7","doi-asserted-by":"publisher","first-page":"947","DOI":"10.1007\/s00431-017-2933-9","volume":"176","author":"P Impellizzeri","year":"2017","unstructured":"Impellizzeri P, Vinci E, Gugliandolo MC, Cuzzocrea F, Larcan R, Russo T, et al. Premedication with melatonin vs midazolam: efficacy on anxiety and compliance in paediatric surgical patients. Eur J Pediatr. 2017;176(7):947\u201353.","journal-title":"Eur J Pediatr"},{"issue":"11","key":"8611_CR8","doi-asserted-by":"publisher","first-page":"1130","DOI":"10.1097\/EJA.0000000000001561","volume":"38","author":"L Singla","year":"2021","unstructured":"Singla L, Mathew PJ, Jain A, Yaddanapudi S, Peters NJ. Oral melatonin as part of multimodal anxiolysis decreases emergence delirium in children whereas midazolam does not: a randomised, double-blind, placebo-controlled study. Eur J Anaesthesiol. 2021;38(11):1130\u20137.","journal-title":"Eur J Anaesthesiol"},{"key":"8611_CR9","doi-asserted-by":"publisher","first-page":"107","DOI":"10.1186\/s12887-022-03149-w","volume":"22","author":"K Mellor","year":"2022","unstructured":"Mellor K, Papaioannou D, Thomason A, Bolt R, Evans C, Wilson M, et al. Melatonin for pre-medication in children: a systematic review. BMC Paediatr. 2022;22:107.","journal-title":"BMC Paediatr."},{"issue":"5","key":"8611_CR10","first-page":"317","volume":"15","author":"G Ansari","year":"2018","unstructured":"Ansari G, Fathi M, Ghajari MF, Bargizan M, Eghbali A. Oral melatonin versus midazolam as premedication for intravenous sedation in pediatric dental patients. Journal of dentistry (Tehran, Iran). 2018;15(5):317\u201324.","journal-title":"Journal of dentistry (Tehran, Iran)."},{"key":"8611_CR11","doi-asserted-by":"publisher","unstructured":"Deery C, Bolt R, Papaioannou D, Totton N, Herbert E, Hyslop M, et al. The MAGIC trial (Melatonin for Anxiety prior to General anaesthesia In Children): a multicentre, parallel randomised controlled trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia. 2023; The University of Sheffield. Workflow. Available from: https:\/\/doi.org\/10.15131\/shef.data.22220884.v1. Accesssed 3 Oct 2024.","DOI":"10.15131\/shef.data.22220884.v1"},{"key":"8611_CR12","doi-asserted-by":"publisher","first-page":"458","DOI":"10.1186\/s13063-021-05425-z","volume":"22","author":"J Kettle","year":"2021","unstructured":"Kettle J, Deery C, Bolt R, Papaioannou D, Marshman Z. Stakeholder perspectives on barriers and enablers to recruiting anxious children undergoing day surgery under general anaesthetic: a qualitative internal pilot study of the MAGIC randomised controlled trial. Trials. 2021;22:458.","journal-title":"Trials."},{"key":"8611_CR13","volume-title":"What\u2019s Wrong with Ethnography?","author":"M Hammersley","year":"1992","unstructured":"Hammersley M. What\u2019s Wrong with Ethnography? London: Routledge; 1992."},{"key":"8611_CR14","first-page":"219","volume-title":"Qualitative Research Practice","author":"J Ritchie","year":"2003","unstructured":"Ritchie J, Spencer L, O\u2019Connor W. Carrying out qualitative analysis. In: Ritchie J, Lewis J, editors. Qualitative research practice. London: SAGE Publications; 2003. p. 219\u201362."},{"issue":"1","key":"8611_CR15","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1016\/j.bja.2023.10.011","volume":"132","author":"R Bolt","year":"2024","unstructured":"Bolt R, Hyslop MC, Herbert E, Papaioannous DE, Totton N, Wilson MJ, et al. The MAGIC trial - A pragmatic, multicentre, parallel, non-inferiority, randomised controlled trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia. Br J Anaesth. 2024;132(1):75\u201385.","journal-title":"Br J Anaesth"},{"key":"8611_CR16","doi-asserted-by":"publisher","first-page":"545","DOI":"10.1097\/01.anes.0000281895.81168.c3","volume":"107","author":"NK Zeev","year":"2007","unstructured":"Zeev NK, McLaren J, McClain BC, Saadat H, Wang S-M, Mayes LC, et al. Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology. 2007;107:545\u201352.","journal-title":"Anesthesiology."},{"issue":"5","key":"8611_CR17","doi-asserted-by":"publisher","first-page":"309","DOI":"10.1111\/j.1365-263X.2006.00750.x","volume":"16","author":"MS Amin","year":"2006","unstructured":"Amin MS, Harrison RL, Weinstein P. A qualitative look at parents\u2019 experience of their child\u2019s dental general anaesthesia. Int J Paediatr Dent. 2006;16(5):309\u201319.","journal-title":"Int J Paediatr Dent"},{"key":"8611_CR18","doi-asserted-by":"publisher","first-page":"E17","DOI":"10.1038\/sj.bdj.2014.333","volume":"216","author":"H Rodd","year":"2014","unstructured":"Rodd H, Hall M, Deery C, Gilchrist F, Gibson BJ, Marshman Z. \u2018I felt weird and wobbly.\u2019 Child-reported impacts associated with a dental general anaesthetic. Br Dent J. 2014;216:E17.","journal-title":"Br Dent J."},{"key":"8611_CR19","doi-asserted-by":"publisher","first-page":"912","DOI":"10.1016\/j.jclinepi.2014.03.010","volume":"67","author":"JL Donovan","year":"2014","unstructured":"Donovan JL, de Salis I, Toerien M, Paramasivan S, Hamdy FC, Blazeby JM. The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials. J Clin Epidemiol. 2014;67:912\u201320.","journal-title":"J Clin Epidemiol."},{"issue":"3","key":"8611_CR20","first-page":"265","volume":"9","author":"KS Davies","year":"2011","unstructured":"Davies KS. Evidence-based medicine: UK doctors\u2019 attitudes and understanding. Int J Evid Based Healthc. 2011;9(3):265\u201373.","journal-title":"Int J Evid Based Healthc"},{"issue":"5","key":"8611_CR21","doi-asserted-by":"publisher","first-page":"701","DOI":"10.2165\/00003495-200767050-00005","volume":"67","author":"N Nathan","year":"2007","unstructured":"Nathan N, Odin I. Induction of anaesthesia: a guide to drug choice. drugs. 2007;67(5):701\u201323.","journal-title":"Drugs."},{"key":"8611_CR22","doi-asserted-by":"publisher","first-page":"510","DOI":"10.1258\/jrsm.2011.110180","volume":"104","author":"ZS Morris","year":"2011","unstructured":"Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011;104:510\u201320.","journal-title":"J R Soc Med"},{"issue":"3","key":"8611_CR23","doi-asserted-by":"publisher","first-page":"427","DOI":"10.1177\/13524585221140270","volume":"29","author":"RJ Fox","year":"2023","unstructured":"Fox RJ, Tervonen T, Phillips-Beyer A, Sidorenko T, Boyanova N, Brooks A, Hennessy B, Jamieson C, Levitan B. The relevance of fatigue to relapse rate in multiple sclerosis: applying patient preference data to the OPTIMUM trial. Mult Scler J. 2023;29(3):427\u201335.","journal-title":"Mult Scler J"},{"key":"8611_CR24","unstructured":"Frax calculation tool. Available from: https:\/\/www.fraxplus.org\/calculation-tool\/. Accessed 3 Oct 2024."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08611-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-024-08611-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-024-08611-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T12:04:48Z","timestamp":1733400288000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-024-08611-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,5]]},"references-count":24,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["8611"],"URL":"https:\/\/doi.org\/10.1186\/s13063-024-08611-x","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12,5]]},"assertion":[{"value":"18 December 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 November 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 December 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study received ethics approval from the North West \u2013 Liverpool Central Research Ethics Committee (reference: IRAS 228234). All adult participants in the qualitative study provided informed consent to be interviewed. Children provided assent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All adult participants in the qualitative study consented to the publication of quotations from their interviews.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"813"}}