Ketamine mouthwash versus placebo in the treatment of severe oral mucositis pain in children with cancer : A randomized double-blind placebo-controlled trial
© 2020 Wiley Periodicals LLC..
BACKGROUND AND AIMS: Oral mucositis (OM) is a common and distressing toxicity in children on chemotherapy. There are a limited number of safe and effective therapeutic options available for OM. Ketamine oral rinse has shown promising results in a 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). No significant adverse events were 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:67 |
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| Enthalten in: |
Pediatric blood & cancer - 67(2020), 9 vom: 15. Sept., Seite e28573 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Prakash, Satya [VerfasserIn] |
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| Links: |
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| Themen: |
690G0D6V8H |
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| Anmerkungen: |
Date Completed 07.12.2020 Date Revised 14.12.2020 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/pbc.28573 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM312257678 |
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| 100 | 1 | |a Prakash, Satya |e verfasserin |4 aut | |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2020 Wiley Periodicals LLC. | ||
| 520 | |a BACKGROUND AND AIMS: Oral mucositis (OM) is a common and distressing toxicity in children on chemotherapy. There are a limited number of safe and effective therapeutic options available for OM. Ketamine oral rinse has shown promising results in a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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). No significant adverse events were observed | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Comparative Study | |
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| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a chemotherapy | |
| 650 | 4 | |a children | |
| 650 | 4 | |a ketamine mouthwash | |
| 650 | 4 | |a oral mucositis pain | |
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| 700 | 1 | |a Gupta, Aditya Kumar |e verfasserin |4 aut | |
| 700 | 1 | |a Bakhshi, Sameer |e verfasserin |4 aut | |
| 700 | 1 | |a Velpandian, Thirumurthy |e verfasserin |4 aut | |
| 700 | 1 | |a Pandey, R M |e verfasserin |4 aut | |
| 700 | 1 | |a Seth, Rachna |e verfasserin |4 aut | |
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