Ketamine Mouthwash versus Placebo in the Treatment of Severe Oral
Mucositis Pain in Children with Cancer: A Randomized Double-Blind
Placebo-Controlled Trial
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.