Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Use of supplemental analgesics
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Allergic to the investigational medical product
- •Alcohol or drug abuse
研究组 & 干预措施
C group I
Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
干预措施: morphine mouthwash (Drug)
C group II
Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
干预措施: Placebo (Drug)
C group I
Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
干预措施: Placebo (Drug)
C group II
Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
干预措施: morphine solution for injection (Drug)
C group III
Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)
干预措施: Placebo (Drug)
结局指标
主要结局
Use of supplemental analgesics
时间窗: 24 hours
次要结局
- 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)
研究者
Bettina Nygaard Nielsen
M.Sc. Pharm, sponsor contact person
Danish University of Pharmaceutical Sciences