"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer

Sankt Lukas Hospice20 enrolled

Overview

The purpose of this study is to test whether "red morphine drops" applied in the mouth are superior to an equivalent amount of morphine applied as subcutaneous injection for the relief of breathlessness in terminal patients suffering from primary lung cancer or lung metastases.

Breathlessness or dyspnea in terminal cancer patients with lung cancer is common and opioids such as morphine is the mainstay of symptomatic treatment. Subcutaneous administration of morphine provides fast symptomatic relief, but it has been the impression in our institution that "red morphine drops" applied orally may have equal or better efficacy and faster onset time. Comparison: Patients with lung cancer or lung metastases with moderate to severe dyspnea at rest are treated with either orally applied "red morphine drops" or an equivalent amount of morphine applied subcutaneously.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dyspnea Lung Neoplasms

Interventions

Morphine p.o.DRUG

Morphine p.o. in "red morphine drops" calculated as 1/12 of the 24 hours opioid consumption converted to morphine p.o., max. 24 mg morphine p.o.and isotonic sodium chloride s.c.

Morphine s.c.DRUG

False "red morphine drops" without morphine p.o. and 60% of 1/12 of the 24 hours opioid consumption converted to morphine p.o. but given s.c., max. 14,4 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary lung cancer or lung metastases and * Moderate to severe dyspnea at rest (VAS equal to or more than 30) Exclusion Criteria: * Causal treatment of dyspnea possible and indicated * Not receiving opioids on a regular basis * Methadone treatment * Intolerance to morphine * Without understanding of patient information * Depressed consciousness * Oxygen treatment, if changed with-in 20 min before start * Short-acting opioids with-in 4 h before start * Inhalation therapy for bronchodilation with-in 20 min before start

Locations (1)

Sankt Lukas Hospice

Copenhagen, Hellerup, Denmark

Outcomes

Primary Outcomes

Dyspnea on a VAS scale

Time frame: 1 hour

Secondary Outcomes

Respiratory rate, pulse rate, oxygen saturation

Time frame: 1 hour

Data from ClinicalTrials.gov

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