Effect of Topical Morphine (Mouthwash) on Oral Pain Due to Chemo- and/or Radiotherapy Induced Mucositis
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
Introduction:
Oral pain due to mucosal lesion is quite frequent in oncology, geriatric as well as
palliative care settings. The oncology patient is mainly suffering from radio- and/or
chemotherapy induced oral mucositis. The incidence of oral mucositis in oncology patients
ranges from 15-40% in those receiving stomatotoxic chemotherapy or radiotherapy. The degree
of mucositis is variable, but the associated pain is frequent and well documented. Nowadays,
basic oral care protocols are the mainstay of preventing or reducing mucositis pain. Pain is
mainly managed by systemically administered analgesia. The only pioneer work in the field of
radio-or chemotherapy induced mucositis treatment with topical opioids has been done by
Cerchietti in two pilot studies: one compared "magic" mouthwash (lidocaine, diphenhydramine,
magnesium aluminium hydroxide) with morphine mouthwash in a randomized trial; the other
compared 1%o and 2% morphine solutions in an open trial. The results showed a significant
decrease in the duration of pain, the intensity as well as a decrease the need for systemic
analgesia in the group with morphine mouthwash. No systemic clinically relevant adverse
effects were noted.
Hypothesis:
Mouthwashes with a morphine containing solution decrease oral pain substantially, while not
causing the side effects seen in systemic administration of narcotic analgesics.
Method:
A randomised double-blind cross-over study to evaluate the effect of topical oral application
of a 0.2% morphine solution in patients suffering from radio- and/or chemotherapy induced
oral mucositis. 60 patients will be included. Randomly assigned to either the morphine
solution or a placebo mouthwash, they receive the first three days one of the solutions and
then are switched over to the other treatment for three more days. General basic oral care is
offered to all of the patients. Efficacy of treatment will be measured with a self-assessment
pain scale. Doses of systemic opioids and other symptoms (appetite, dysphagia) will also be
measured. If patient's don't receive systemic opioids, serum concentrations of morphine will
be measured.