drugset / Trial / NCT00357942
Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy
Phase 4
Completed
72 enrolled
Danish University of Pharmaceutical Sciences
Copenhagen University Hospital, Denmark · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2006-09
- Primary completion
- 2013-12
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Morphine | Other / unclassified | 50 ug/kg | Intravenous |
| Comparator | Morphine | Other / unclassified | 2 mg/ml | Intravenous |