Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children
Phase 4
N/A
N/A
N/A
N/A
Open (Enrolling)
Both
Pain, Mucositis
Both
Pain, Mucositis
Trial Information
Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Use of supplemental analgesics
Outcome Time Frame:
24 hours
Safety Issue:
No
Principal Investigator
Bettina N Nielsen, PhD student M.Sc.Pharm
Investigator Role:
Study Chair
Investigator Affiliation:
Faculty of Pharmaceutical Sciences, University of Copenhagen
Authority:
Denmark: Danish Medicines Agency
Study ID:
102010
NCT ID:
NCT00357942
Start Date:
September 2006
Completion Date:
July 2014
Related Keywords:
- Pain
- Mucositis
- Morphine
- Mouthwash
- Mucositis
- Pain
- Cancer
- Child
- Adolescent
- Stomatitis
- Mucositis
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