Cancer
Conditions
Keywords
chemotherapy, mucositis, systemic opioids, morphine
Brief summary
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.
Detailed description
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
Interventions
DRUGmorphine gel
1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose
DRUGplacebo gel
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
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Children older than 5 years or adults over 18 and up to 25 years with a chemotherapy * greater than or equal to grade 2 mucositis that has lasted for 24 hours and treated with systemic opioid
Exclusion criteria
* Patients in emergency ward -Patients having difficulties in understanding the study - * Patients who have already been treated with oral morphine gel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in pain of mucositis before and after meal | Daily assessment through out the mucositis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the local tolerance and other topical treatment taken throughout the mucositis | daily, 8-21 days throughout the mucositis | Evaluation of the local tolerance ( taste, burns) with a questionnaire |
Countries
France
Outcome results
None listed