{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T15:07:28Z","timestamp":1779289648518,"version":"3.51.4"},"reference-count":22,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T00:00:00Z","timestamp":1779235200000},"content-version":"unspecified","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Fondation LENVAL \u2013 Lenval Children\u2019s Hospital, Nice"},{"name":"FONDATION APICIL"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,3,23]]},"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Effective management of severe pain in children presenting to emergency departments remains challenging. Intravenous analgesia is often delayed due to technical and emotional difficulties related to vascular access. Intranasal administration offers a rapid, needle-free route. Although ketamine is widely used intranasally for paediatric analgesia, sufentanil may represent a potent alternative with favourable pharmacological properties. However, comparative paediatric data are lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>SUF-KET-PED is a single-centre, randomised controlled superiority trial conducted in the paediatric emergency department of Lenval Children\u2019s Hospital, Nice, France. A total of 116 children aged 6 to 17 years presenting with severe traumatic limb pain (Visual Analogue Scale (VAS) &gt;6\/10) will be randomised in a 1:1 ratio to receive either intranasal sufentanil at 0.5\u2009\u00b5g\/kg or ketamine at 1\u2009mg\/kg in addition to standard care including inhaled nitrous oxide-oxygen mixture. Pain will be assessed using the VAS at baseline and at predefined intervals up to 30\u2009min. Sedation will be monitored using the Ramsay Sedation Scale and adverse events will be recorded throughout a 60-minute follow-up period.<\/jats:p>\n                    <jats:p>The primary outcome is the mean change in VAS score between baseline and 30\u2009min. Secondary outcomes include time to effective analgesia, excessive sedation, adverse events, use of rescue analgesia and patient and parent satisfaction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study was approved by the French Ethics Committee CPP Sud M\u00e9diterran\u00e9e V and authorised by the French National Agency for Medicines and Health Products Safety, IDRCB no 2025-521075-31-00. Results will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      EU Clinical Trials Information System: 2025-521075-31-00. ClinicalTrials.gov:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06968546\">NCT06968546<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-112617","type":"journal-article","created":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T14:10:40Z","timestamp":1779286240000},"page":"e112617","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Intranasal sufentanil versus ketamine for acute severe traumatic pain in children: protocol for a phase II randomised controlled trial (SUF-KET-PED)"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06968546","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06968546","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-8550-502X","authenticated-orcid":false,"given":"C\u00e9line","family":"Mendes Dos Reis","sequence":"first","affiliation":[{"name":"Paediatric Emergency, H\u00f4pitaux P\u00e9diatriques de Nice CHU-LENVAL, Nice, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Olla","sequence":"additional","affiliation":[{"name":"Paediatric Emergency, H\u00f4pitaux P\u00e9diatriques de Nice CHU-LENVAL, Nice, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Freyssinet","sequence":"additional","affiliation":[{"name":"Paediatric Emergency, H\u00f4pitaux P\u00e9diatriques de Nice CHU-LENVAL, Nice, France"},{"name":"Equipe de Recherche EA 3279 \"Sant\u00e9 Publique, Maladies Chroniques et Qualit\u00e9 de Vie\u201d, Aix-Marseille Universit\u00e9, Marseille, France"},{"name":"School of medicine, Universit\u00e9 C\u00f4te d\u2019Azur, Nice, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Baranton","sequence":"additional","affiliation":[{"name":"Paediatric Emergency, H\u00f4pitaux P\u00e9diatriques de Nice CHU-LENVAL, Nice, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aline","family":"Joulie","sequence":"additional","affiliation":[{"name":"D\u00e9l\u00e9gation \u00e0 la Recherche Clinique et \u00e0 l\u2019Innovation, CHU Nice, Nice, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Fontas","sequence":"additional","affiliation":[{"name":"D\u00e9l\u00e9gation \u00e0 la Recherche Clinique et \u00e0 l\u2019Innovation, CHU Nice, Nice, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1836-2742","authenticated-orcid":false,"given":"Antoine","family":"Tran","sequence":"additional","affiliation":[{"name":"Paediatric Emergency, H\u00f4pitaux P\u00e9diatriques de Nice CHU-LENVAL, Nice, France"},{"name":"Equipe de Recherche EA 3279 \"Sant\u00e9 Publique, Maladies Chroniques et Qualit\u00e9 de Vie\u201d, Aix-Marseille Universit\u00e9, Marseille, France"},{"name":"School of medicine, Universit\u00e9 C\u00f4te d\u2019Azur, Nice, France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,5,20]]},"reference":[{"key":"2026052007101900000_16.5.e112617.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annemergmed.2003.11.019"},{"key":"2026052007101900000_16.5.e112617.2","doi-asserted-by":"crossref","first-page":"287","DOI":"10.1007\/s40272-016-0181-5","article-title":"Managing Pediatric Pain in the Emergency Department","volume":"18","author":"Bailey","year":"2016","journal-title":"Paediatr Drugs"},{"key":"2026052007101900000_16.5.e112617.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharmthera.2012.03.003"},{"key":"2026052007101900000_16.5.e112617.4","first-page":"217","article-title":"Intranasal drug administration for procedural sedation in children admitted to pediatric Emergency Room","volume":"22","author":"Fantacci","year":"2018","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"2026052007101900000_16.5.e112617.5","doi-asserted-by":"crossref","DOI":"10.1186\/s12887-023-04203-x","article-title":"Intranasal analgesia for acute moderate to severe pain in children - a systematic review and meta-analysis","volume":"23","author":"Prescott","year":"2023","journal-title":"BMC Pediatr"},{"key":"2026052007101900000_16.5.e112617.6","doi-asserted-by":"publisher","DOI":"10.1111\/acem.13313"},{"key":"2026052007101900000_16.5.e112617.7","doi-asserted-by":"crossref","first-page":"1860","DOI":"10.1016\/j.ajem.2020.05.094","article-title":"Intranasal ketamine for acute pain management in children: A systematic review and meta-analysis","volume":"38","author":"Oliveira J. e Silva","year":"2020","journal-title":"Am J Emerg Med"},{"key":"2026052007101900000_16.5.e112617.8","doi-asserted-by":"crossref","DOI":"10.3390\/jcm10173978","article-title":"Efficacy and Safety of Intranasal Ketamine for Acute Pain Management in the Emergency Setting: A Systematic Review and Meta-Analysis","volume":"10","author":"Seak","year":"2021","journal-title":"J Clin Med"},{"key":"2026052007101900000_16.5.e112617.9","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1016\/j.ajem.2023.04.020","article-title":"A systematic review of sufentanil for the management of adults with acute pain in the emergency department and pre-hospital setting","volume":"70","author":"Hutchings","year":"2023","journal-title":"Am J Emerg Med"},{"key":"2026052007101900000_16.5.e112617.10","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1007\/s11739-018-02014-y","article-title":"Intranasal sufentanil given in the emergency department triage zone for severe acute traumatic pain: a randomized double-blind controlled trial","volume":"14","author":"Lemoel","year":"2019","journal-title":"Intern Emerg Med"},{"key":"2026052007101900000_16.5.e112617.11","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1002849","article-title":"Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study","volume":"16","author":"Blancher","year":"2019","journal-title":"PLoS Med"},{"key":"2026052007101900000_16.5.e112617.12","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1016\/j.jemermed.2018.12.002","article-title":"Intranasal Sufentanil Versus Intravenous Morphine for Acute Pain in the Emergency Department: A Randomized Pilot Trial","volume":"56","author":"Sin","year":"2019","journal-title":"J Emerg Med"},{"key":"2026052007101900000_16.5.e112617.13","doi-asserted-by":"publisher","DOI":"10.1111\/j.1460-9592.2010.03411.x"},{"key":"2026052007101900000_16.5.e112617.14","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2016-012190","article-title":"Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department","volume":"6","author":"Reynolds","year":"2016","journal-title":"BMJ Open"},{"key":"2026052007101900000_16.5.e112617.15","doi-asserted-by":"crossref","first-page":"170","DOI":"10.1111\/pan.12268","article-title":"Intranasal sufentanil\/ketamine analgesia in children","volume":"24","author":"Nielsen","year":"2014","journal-title":"Paediatr Anaesth"},{"key":"2026052007101900000_16.5.e112617.16","doi-asserted-by":"publisher","DOI":"10.1007\/BF03005373"},{"key":"2026052007101900000_16.5.e112617.17","doi-asserted-by":"crossref","first-page":"1439","DOI":"10.7150\/ijms.34656","article-title":"Comparison of the Analgesic Effect of Sufentanil versus Fentanyl in Intravenous Patient-Controlled Analgesia after Total Laparoscopic Hysterectomy: A Randomized, Double-blind, Prospective Study","volume":"16","author":"Oh","year":"2019","journal-title":"Int J Med Sci"},{"key":"2026052007101900000_16.5.e112617.18","doi-asserted-by":"crossref","DOI":"10.1186\/s12873-016-0107-0","article-title":"Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety","volume":"16","author":"Shimonovich","year":"2016","journal-title":"BMC Emerg Med"},{"key":"2026052007101900000_16.5.e112617.19","first-page":"23","article-title":"Clinical meaning of a decline in pain intensity in children and its implications in care and research","volume":"8","author":"Cepeda","year":"2006","journal-title":"Pediatr Pain Lett"},{"key":"2026052007101900000_16.5.e112617.20","doi-asserted-by":"crossref","first-page":"140","DOI":"10.1001\/jamapediatrics.2018.4582","article-title":"Effect of Intranasal Ketamine vs Fentanyl on Pain Reduction for Extremity Injuries in Children: The PRIME Randomized Clinical Trial","volume":"173","author":"Frey","year":"2019","journal-title":"JAMA Pediatr"},{"key":"2026052007101900000_16.5.e112617.21","doi-asserted-by":"publisher","DOI":"10.1016\/S0196-0644(96)70238-X"},{"key":"2026052007101900000_16.5.e112617.22","doi-asserted-by":"publisher","DOI":"10.1067\/mem.2001.118863"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-112617","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T14:10:43Z","timestamp":1779286243000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-112617"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5]]},"references-count":22,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2026,5,20]]},"published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1136\/bmjopen-2025-112617"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-112617","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5]]}}}