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Completed

NCT Number: NCT00357942

Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

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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Key information

Conditions

Pain Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)

Copenhagen, DK-2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Use of supplemental analgesics

    Time frame: 24 hours

Secondary outcomes

  1. Pain score at rest

    Time frame: 24 hours

  2. Pain score at activity (performance of oral hygiene)

    Time frame: 24 hours

  3. Time to first dose of supplemental analgesics

    Time frame: 24 hours

  4. Frequency and severity of side effects

    Time frame: 24 hours

  5. Oral intake of food

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Danish University of Pharmaceutical Sciences

Other

Collaborators

  • Copenhagen University Hospital, Denmark

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2014
First posted
Jul 28, 2006
Registry last updated
Feb 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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