NCT00357942

Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Danish University of Pharmaceutical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pain
• Mucositis

Interventions

Type	Name	Description
DRUG	morphine solution for injection	morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash
DRUG	Placebo	Placebo mouthwash
DRUG	morphine mouthwash	morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection
DRUG	Placebo	Placebo solution for injection every 3 hour for 24 hours

Timeline

• Start date: 2006-09-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2006-07-28
• Last updated: 2014-02-21

Locations

1 site across 1 country: Denmark