drugset / Trial / NCT00357942

Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

NCT00357942 ↗

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

EvaluationDrugModalityDoseRoute
Comparator Morphine Other / unclassified 50 ug/kg Intravenous
Comparator Morphine Other / unclassified 2 mg/ml Intravenous

Indications