{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T00:40:07Z","timestamp":1760834407641,"version":"build-2065373602"},"reference-count":74,"publisher":"BMJ","issue":"7","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2017,5,31]]},"published-print":{"date-parts":[[2017,7]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Pediatric sickle cell disease, highly prevalent in sub-Saharan Africa, carries great morbidity and mortality risk. Limited resources and monitoring make management of acute vaso-occlusive crises challenging. This study aims to evaluate the efficacy and safety of subdissociative intranasal ketamine as a cheap, readily available and easily administered adjunct to standard pain therapy. We hypothesise that subdissociative, intranasal ketamine may significantly augment current approaches to pain management in resource-limited settings in a safe and cost-effective manner.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>This is a multicentred, randomised, double-blind, placebo-controlled trial enrolling children 4\u201316 years of age with sickle cell disease and painful vaso-occlusive pain crises. Study sites include two sub-Saharan teaching and referral hospitals with acute intake areas. All patients receive standard analgesic therapy during evaluation. Patients randomised to the treatment arm receive 1 mg\/kg intranasal ketamine at onset of therapy, while placebo arm participants receive volume-matched intranasal normal saline. All participants and clinical staff are blinded to the treatment allocation. Data will be analysed on an intention-to-treat basis. Primary endpoints are changes in self-report pain scales (Faces Pain Scale-Revised) at 30, 60 and 120 minutes and rates of adverse events. Secondary endpoints include hospital length of stay, total analgesia use and quality of life assessment 2\u20133 weeks postintervention.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>The research methods for this study have been approved by the Cameroon Baptist Convention Health Board Institutional Review Board (IRB2015-07), the Tanzanian National Institute for Medical Research (NIMR\/HQ\/R.8a\/Vol. IX\/2299), Muhimbili National Hospital IRB (MNH\/IRB\/I\/2015\/14) and the Tanzanian Food and Drugs Authority (TFDA0015\/CTR\/0015\/9). Data reports will be provided to the Data and Safety Monitoring Board (DSMB) periodically throughout the study as well as all reports of adverse events. All protocol amendments will also be reviewed by the DSMB. Study results, regardless of direction or amplitude, will be submitted for publication in relevant peer-reviewed journals.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration<\/jats:title>\n                  <jats:p>ClinicalTrials.Gov, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02573714\">NCT02573714<\/jats:ext-link>. Date of registration: 8 October 2015. Pre-results.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-017190","type":"journal-article","created":{"date-parts":[[2017,7,11]],"date-time":"2017-07-11T20:10:16Z","timestamp":1499803816000},"page":"e017190","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Subdissociative intranasal ketamine plus standard pain therapy versus standard pain therapy in the treatment of paediatric sickle cell disease vaso-occlusive crises in resource-limited settings: study protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"7","clinical-trial-number":[{"clinical-trial-number":"nct02573714","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7776-7600","authenticated-orcid":false,"given":"James R","family":"Young","sequence":"first","affiliation":[{"name":"Division of Pediatric Emergency Medicine, Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hendry Robert","family":"Sawe","sequence":"additional","affiliation":[{"name":"Deparment of Emergency Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juma A","family":"Mfinanga","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, Muhimbili National Hospital, Dar es Salaam, United Republic of Tanzania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ernest","family":"Nshom","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, CIMS, Mbingo Baptist Hospital, Cameroon Baptist Convention, Mbingo, Cameroon"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ethan","family":"Helm","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Mbingo Baptist Hospital, Cameroon Baptist Convention, Mbingo, Cameroon"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charity G","family":"Moore","sequence":"additional","affiliation":[{"name":"Center for Outcomes Research and Evaluation, Carolinas HealthCare System, Charlotte, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael S","family":"Runyon","sequence":"additional","affiliation":[{"name":"Division of Pediatric Emergency Medicine, Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stacy L","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Division of Pediatric Emergency Medicine, Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2017,7,10]]},"reference":[{"key":"2025101815103846000_7.7.e017190.1","doi-asserted-by":"crossref","first-page":"743","DOI":"10.7196\/SAMJ.8470","article-title":"Recommendations for the management of sickle cell disease in South Africa","volume":"104","author":"Alli","year":"2014","journal-title":"S Afr Med J"},{"key":"2025101815103846000_7.7.e017190.2","unstructured":"World Health Organization. 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