Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect.

The purpose of this study is to test the analgesic effect of a morphine mouthwash versus morphine injections or placebo (no active drug) in children/adolescents with stomatitis related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine injections) the children/adolescents receive a standardized analgesic treatment for stomatitis-related pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish University of Pharmaceutical Sciences
• Collaborator: Copenhagen University Hospital, Denmark
• Treatments: Analgesics; Morphine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Children and adolescents at The Juliane Marie Center at Copenhagen University Hospital (Rigshospitalet, Denmark) or at The University Hospital in Lund (Sweden)

• Receiving chemotherapy in relation to a cancer disease

• Pain score of minimum 3 (VAS-scale) at rest for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale) or a pain score of minimum 5 (VAS-scale) at activity for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale)

• Negative pregnancy test, when relevant (judged by physician)

• Patients and/or parents understand and speak danish (Denmark) / swedish (Sweden)

• Signed informed consent

Exclusion Criteria:

• Allergic to the investigational medical product

• Alcohol or drug abuse