Evaluation of Oral Morphine Gel in Oral Mucositis Induced by Chemotherapy in Children and Young Adults

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Morphine

Criteria

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