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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose
Sterile placebo gel with raspberry aroma, 30% glucose presented in 5 mL syringe (single dose) of the same appearance and the same packaging as morphine gel to maintain the blind
Service d'oncohématologie pédiatrique, Hôpital de Hautepierre
Strasbourg, Alsace, France
change in pain of mucositis before and after meal
Pain is assessed before gel application and 30 minutes after application (i e 8 times per day and for the duration of the mucositis between 8 to 21 days). The gel is administered 4 times daily 30 minutes before each meal. Response to treatment is defined as a greater than or equal to 30% decrease in pain level between before and after application of the gel.
Time frame: Daily assessment through out the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Evaluation of the local tolerance ( taste, burns) with a questionnaire
Time frame: daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Assessment of the quantity of morphine in mg/ day (reported in mg morphine), the nature and amount of all systemic analgesics
Time frame: daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Daily grading of mucositis by the doctor
Time frame: daily, 8-21 days throughout the mucositis
Evaluation of the local tolerance and other topical treatment taken throughout the mucositis
Daily evaluation of other topical treatments administered (mouthwashes: time frames when administered, doses, nature)
Time frame: daily, 8-21 days throughout the mucositis
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