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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003260-53 | |||
| 2006-003260-53 | EudraCT Number |
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| Name | Class |
|---|---|
| Copenhagen University Hospital, Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C group I | Experimental | Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) |
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| C group II | Active Comparator | Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) |
|
| C group III | Placebo Comparator | Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| morphine solution for injection | Drug | morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash |
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| Measure | Description | Time Frame |
|---|---|---|
| Use of supplemental analgesics | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score at rest | 24 hours | |
| Pain score at activity (performance of oral hygiene) | 24 hours | |
| Time to first dose of supplemental analgesics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina N Nielsen, PhD student M.Sc.Pharm | Faculty of Pharmaceutical Sciences, University of Copenhagen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet) | Copenhagen | DK-2100 | Denmark |
| ID | Term |
|---|---|
| D010146 | Pain |
| D052016 | Mucositis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebo | Drug | Placebo mouthwash |
|
| morphine mouthwash | Drug | morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection |
|
| Placebo | Drug | Placebo solution for injection every 3 hour for 24 hours |
|
| 24 hours |
| Frequency and severity of side effects | 24 hours |
| Oral intake of food | 24 hours |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |