title: Treatment of severe mucositis pain with oral ketamine mouthwash.
abstract: Mucositis is a significant complication of intensive chemotherapy or hematopoietic cell transplantation (HCT), with few treatment options. Ketamine mouthwashes have been used for pain relief, but supporting evidence is limited. The primary objective of this study was to assess the reduction in pain intensity of stomatodynia and odynophagia compared to baseline assessment.
  
  
  
  This open-label, prospective, phase II interventional study (NCT01566448) was conducted from February 2012 through July 2015. Patients with grade 3 or 4 oral mucositis according to the World Health Organization (WHO) scale as a result of chemotherapy were treated with ketamine mouthwash 20 mg/5 mL four times daily and every 4 h as needed.
  
  
  
  Thirty patients were enrolled and a total of 136 assessments were conducted. A statistically significant reduction in pain scores of 2 and 3 points was achieved after 1 h and 3 days, respectively (p < 0.0001, p = 0.0003). Pain scores were significantly improved while swallowing, reduced 1 and 4 points at 1-h and 3-day assessment, respectively (p = 0.0006, p = 0.0001). No patients developed adverse effects related to ketamine administration.
  
  
  
  Ketamine mouthwashes resulted in clinically meaningful and statistically significant reduction in pain scores, have an acceptable safety profile, and can be a useful adjunctive treatment in the multi-modal management of severe mucositis.
authors.affiliation: Department of Pharmacy, West Virginia University Medicine, P.O. Box 8045, Medical Center Drive, Morgantown, WV, 26506, USA. shillingburga@wvumedicine.org.|Osborn Hematopoietic Malignancy and Transplantation Program, West Virginia University Cancer Institute, Morgantown, WV, USA. shillingburga@wvumedicine.org.
authors.forename: Alexandra
authors.identifier: 0000-0001-6128-3225
authors.initials: A
authors.lastname: Shillingburg
authors.affiliation: Osborn Hematopoietic Malignancy and Transplantation Program, West Virginia University Cancer Institute, Morgantown, WV, USA.
authors.forename: Abraham S
authors.initials: AS
authors.lastname: Kanate
authors.affiliation: Division of Hematology/Oncology, Medical College of Wisconsin, Milwaukee, WI, USA.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Hamadani
authors.affiliation: Department of Biostatistics, West Virginia University Cancer Institute, Morgantown, WV, USA.
authors.forename: Sijin
authors.initials: S
authors.lastname: Wen
authors.affiliation: Osborn Hematopoietic Malignancy and Transplantation Program, West Virginia University Cancer Institute, Morgantown, WV, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Craig
authors.affiliation: Department of Pharmacy, West Virginia University Medicine, P.O. Box 8045, Medical Center Drive, Morgantown, WV, 26506, USA.|Osborn Hematopoietic Malignancy and Transplantation Program, West Virginia University Cancer Institute, Morgantown, WV, USA.
authors.forename: Aaron
authors.initials: A
authors.lastname: Cumpston
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006801:Humans; D007649:Ketamine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use*; D052016:Mucositis / Q000188:drug therapy* / Q000209:etiology; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D013280:Stomatitis / Q000150:complications* / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D009067:Mouthwashes; D007649:Ketamine
keywords: Ketamine; Mouthwash; Mucositis; Oral; Pain; Transplant