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Ketamine Mouthwash versus Placebo in the Treatment of Severe Oral Mucositis Pain in Children with Cancer: A Randomized Double-Blind Placebo-Controlled Trial
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  • Satya Prakash,
  • Jagdish Meena,
  • Aditya Gupta,
  • Sameer Bakhshi,
  • Thirumurthy Velpandian,
  • Ravindra Pandey,
  • Rachna Seth
Satya Prakash
All India Institute of Medical Sciences
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Jagdish Meena
All India Institute of Medical Sciences
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Aditya Gupta
All India Institute of Medical Sciences
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Sameer Bakhshi
All India Institute of Medical Sciences
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Thirumurthy Velpandian
All India Institute of Medical Sciences
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Ravindra Pandey
All India Institute of Medical Sciences
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Rachna Seth
All India Institute of Medical Sciences
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Abstract

Background and aims: Oral mucositis (OM) is common and distressing toxicity in children on chemotherapy. There is limited number of safe and effective therapeutic options available for OM. Ketamine oral rinse has shown promising results in few studies in adults. This randomized, double-blind placebo-controlled trial aimed to test the efficacy of ketamine mouthwash in reducing chemotherapy-induced severe OM pain in children. Methods: Children aged 8-18 years with severe OM were randomized to a single dose of ketamine mouthwash (4 mg/ml solution; dose 1 mg/kg) or a placebo. A sample size of 44 patients was determined. Pain score (6-point faces scale) was noted at baseline and 15, 30, 45, 60, 120, 180, and 240 min. The outcome variables were a reduction in pain score, need for rescue medications, and adverse events. Results: The baseline characteristics were comparable in the two groups. The mean OM pain at 60 min decreased by 1.64 points (CI 1.13-2.14) in the ketamine group and 1.32 points (CI 0.76-1.87) in the placebo group (p=0.425), with a group difference of 0.32 points. Rescue pain medication (at 60 min) was required in 13.6% in the ketamine group and 18.2% in the placebo group (p=1.000). There were no significant adverse events observed. Conclusions: Among children on cancer chemotherapy with severe OM, ketamine mouthwash at a dose of 1 mg/kg did not significantly reduce OM pain. It did not decrease the need for rescue pain medications. Further research is warranted to test higher doses of ketamine for a clinically significant effect.

Peer review status:Published

05 Jun 2020Submission Checks Completed
05 Jun 2020Assigned to Editor
05 Jun 2020Submitted to Pediatric Blood & Cancer
05 Jun 2020Reviewer(s) Assigned
23 Jun 2020Review(s) Completed, Editorial Evaluation Pending
23 Jun 2020Editorial Decision: Revise Major
25 Jun 2020Submission Checks Completed
25 Jun 2020Assigned to Editor
25 Jun 20201st Revision Received
25 Jun 2020Review(s) Completed, Editorial Evaluation Pending
25 Jun 2020Editorial Decision: Accept
Sep 2020Published in Pediatric Blood & Cancer volume 67 issue 9. 10.1002/pbc.28573