Effect of Topical Morphine (Mouthwash) on Oral Pain Due to Chemo- and/or Radiotherapy Induced Mucositis
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
difference of pain alleviation in the two branches one hour after mouthwash and as well as the duration of pain relief.
Sophie Pautex, MD
University Hospital, Geneva
Switzerland: institut suisse produits thérapeutiques