Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

Danish University of Pharmaceutical Sciences

Status and phase: Completed; Phase 4

Conditions: Mucositis; Pain

Treatments: Drug: Placebo; Drug: morphine solution for injection; Drug: morphine mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT00357942

2006-003260-53

102010

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups, including a placebo group

C group I

Experimental group

Description:

Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Treatment:

Drug: morphine mouthwash

Drug: Placebo

Drug: Placebo

C group II

Active Comparator group

Description:

Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Treatment:

Drug: morphine solution for injection

Drug: Placebo

Drug: Placebo

C group III

Placebo Comparator group

Description:

Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Treatment:

Drug: Placebo

Drug: Placebo