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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00357942

Enrollment

Registered

2006-07-28

Start date

2006-09-30

Completion date

2014-01-31

Last updated

2014-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis, Pain

Keywords

Morphine, Mouthwash, Mucositis, Pain, Cancer, Child, Adolescent

Brief 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.

Interventions

DRUGmorphine solution for injection

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

DRUGPlacebo

Placebo mouthwash

DRUGmorphine mouthwash

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Use of supplemental analgesics	24 hours

Secondary

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026