Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Mucositis

Intervention / Treatment
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* Drug: morphine solution for injection
* Drug: Placebo
* Drug: morphine mouthwash
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C group I<br>Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) | Drug: morphine mouthwash<br>* morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection<br>Drug: Placebo<br>* Placebo solution for injection every 3 hour for 24 hours<br>|
| Active Comparator: C group II<br>Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) | Drug: morphine solution for injection<br>* morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash<br>Drug: Placebo<br>* Placebo mouthwash<br>|
| Placebo Comparator: C group III<br>Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine) | Drug: Placebo<br>* Placebo mouthwash<br>Drug: Placebo<br>* Placebo solution for injection every 3 hour for 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of supplemental analgesics |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 24 hours | 
| Frequency and severity of side effects |  | 24 hours | 
| Oral intake of food |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mucositis, Pain, Cancer, Child, Adolescent, Mouthwash, Morphine