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: Recruiting

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

Overall contact:
Bettina N Nielsen, PhD student M.Sc.Pharm, Phone: 0045 35336228, Email: bnn@farma.ku.dk

Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with soreness and painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local pain-relieving effect.

The purpose of this study is to test the pain-relieving 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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Bettina N Nielsen, PhD student M.Sc.Pharm, Phone: 0045 35336228, Email: bnn@farma.ku.dk

The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet), Copenhagen DK-2100, Denmark; Recruiting
Kjeld Schmiegelow, Professor M.D., Principal Investigator
Steen W. Henneberg, M.D., Sub-Investigator

Barn- och Ungdomssjukvård, Universitetssjukhuset i Lund, Lund 221 85, Sweden; Not yet recruiting
Mariann Stenberg, MD, Principal Investigator

Starting date: September 2006
Ending date: December 2009
Last updated: January 8, 2009