Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

Condition(s) targeted: Pain; Mucositis

Intervention: morphine solution for injection (Drug); Placebo (Drug); morphine mouthwash (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Danish University of Pharmaceutical Sciences

Official(s) and/or principal investigator(s):
Bettina N Nielsen, PhD student M.Sc.Pharm, Study Chair, Affiliation: Faculty of Pharmaceutical Sciences, University of Copenhagen

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.

Official title: Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Use of supplemental analgesics

Secondary outcome:

Pain score at rest

Pain score at activity (performance of oral hygiene)

Time to first dose of supplemental analgesics

Frequency and severity of side effects

Oral intake of food

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children and adolescents at The Juliane Marie Center at Copenhagen University

Hospital (Rigshospitalet, Denmark) or at The University Hospital in Lund (Sweden)

- Receiving chemotherapy in relation to a cancer disease

- Pain score of minimum 3 (VAS-scale) at rest for mouth pain in combination with

stomatitis of minimum grade 1 (WHO-scale) or a pain score of minimum 5 (VAS-scale) at activity for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale)

- Negative pregnancy test, when relevant (judged by physician)

- Patients and/or parents understand and speak danish (Denmark) / swedish (Sweden)

- Signed informed consent

Exclusion Criteria:

- Allergic to the investigational medical product

- Alcohol or drug abuse

The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet), Copenhagen DK-2100, Denmark

Starting date: September 2006
Last updated: February 20, 2014