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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001686-16 | EudraCT Number |
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Numerous premature study discontinuations due to adverse events
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral morphine gel | Experimental | 1 mg / ml of Morphine hydrochloride, presented in a 5 mL sterile syringe (single dose). Gel will be applied 8 times per day and for the duration of the mucositis (between 8 to 21 days). |
|
| placebo gel | Placebo Comparator | 1 mg / ml of Placebo gel that is presented in a 5 mL sterile syringe (single dose). Gel will be applied 8 times per day and for the duration of the mucositis (between 8 to 21 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| morphine gel | Drug | 1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily assessment through out the mucositis |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the local tolerance and other topical treatment taken throughout the mucositis | Evaluation of the local tolerance ( taste, burns) with a questionnaire | daily, 8-21 days throughout the mucositis |
| Evaluation of the local tolerance and other topical treatment taken throughout the mucositis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'oncohématologie pédiatrique, Hôpital de Hautepierre | Strasbourg | Alsace | 67098 | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| placebo gel | Drug | 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 |
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Assessment of the quantity of morphine in mg/ day (reported in mg morphine), the nature and amount of all systemic analgesics |
| 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 | 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) | daily, 8-21 days throughout the mucositis |
| D009057 |
| Stomatognathic Diseases |