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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash
Placebo mouthwash
morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection
Placebo solution for injection every 3 hour for 24 hours
The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)
Copenhagen, Denmark
Use of supplemental analgesics
Time frame: 24 hours
Pain score at rest
Time frame: 24 hours
Pain score at activity (performance of oral hygiene)
Time frame: 24 hours
Time to first dose of supplemental analgesics
Time frame: 24 hours
Frequency and severity of side effects
Time frame: 24 hours
Oral intake of food
Time frame: 24 hours
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