Cancer Clinical Trial
Chemotherapy kills tumor cells but can also damage healthy cells and cause significant
digestive disorders such as ulcers of the mouth, called mucositis. Mucositis are transient
but their intensity may require special measures. Mucositis are painful and morphine gel or
intravenous morphine is used to relieve pain.
However, the pain of oral mucositis induced by chemotherapy is not completely relieved by
morphine administered intravenously.
As part of the study, the investigators want to evaluate an oral gel containing a small
amount of morphine so that it acts directly on the mucositis. The investigators believe that
the direct action of morphine on mucositis may be more effective on pain.
The objective of the study is to compare the analgesic efficacy of topical morphine gel
versus placebo gel in the pediatric oncohaematology oral mucositis induced by chemotherapy
in children treated with systemic opioids.
To confirm these results, we propose to conduct a randomized double-blinded study designed
to compare the analgesic efficacy of morphine oral topical gel versus placebo gel in
children over 5 years with mucositis induced by chemotherapy and treated with systemic
opioids. This analgesic effect should reduce persistent pain to maintain oral feeding and
thus delay the implementation of parenteral nutrition, and hence reduce the dose of systemic
morphine and also reduce the adverse effects of opioids
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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