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Morphine Hydrochloride for Resting Breathlessness in Adults with Serious Chronic Life‑Limiting Disease Receiving Palliative Care

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on people with a serious chronic life‑limiting disease who often feel shortness of breath even while resting. The study tests whether a low dose of morphine can reduce this breathlessness compared with a simple saline solution used as a placebo. Both the medication and the placebo are given by a subcutaneous injection, which means the fluid is placed just under the skin.

The purpose of the study is to see if the breathlessness rating improves after the medication is given. Participants are randomly assigned to receive either the morphine or the saline solution, and they are asked to rate how strong their breathlessness feels using a short questionnaire called ESAS-r. The rating is recorded before the injection and again about half an hour and one hour afterward.

During the short observation period, basic safety checks such as breathing rate and level of alertness are monitored, and any side effects are noted. The study follows each participant for a brief time after the injection to ensure safety and to collect the final breathlessness scores.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
After enrollment you are randomly assigned to receive either morphine or a placebo (sodium chloride). the assignment is unknown to you.
Step 2
Baseline assessment
You complete the ESAS-r questionnaire, rating breathlessness and other symptoms such as pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety and wellbeing.
A nurse measures your oxygen level (SpO2), breathing rate and level of consciousness using the GCS scale.
Step 3
Receive injection
A single subcutaneous injection (under the skin) of 9 ml is given.
If you are in the test group the injection contains morphine 10 mg/ml, delivering a total of 90 mg of morphine.
If you are in the control group the injection contains 9 ml of sodium chloride solution (placebo).
Step 4
30‑minute follow‑up
30 minutes after the injection you again rate your breathlessness on the ESAS-r questionnaire.
Step 5
60‑minute follow‑up
60 minutes after the injection you repeat the breathlessness rating on the ESAS-r questionnaire.
The nurse records your oxygen level (SpO2), breathing rate, level of consciousness (GCS) and any side effects or adverse reactions.
Step 6
Adverse‑reaction monitoring
Any adverse drug reactions that may be related to the study medication are documented before any further dose (no additional doses are scheduled) and at the end of the 60‑minute observation period.
Step 7
Study completion and follow‑up
After the 60‑minute assessment the active part of the trial for you is finished.
Information about death, if it occurs, may be collected for up to three months after the first randomization.

Who can join the trial?

6 criteria

Signed informed consent: you must sign a document that shows you understand the study and agree to take part.
Age 18 years or older: you must be at least 18 years old.
Having a serious, chronic, life‑limiting disease: you must have a long‑term illness that is serious and expected to affect your lifespan.
Short expected survival as judged by staff, using the “surprise question”: “Would you be surprised if the patient died within the next year?” – staff must answer “no,” meaning they think you are unlikely to live more than a year.
Ability to self‑report symptoms: you must be able to tell the researchers about how you feel.
Self‑rated breathlessness of at least 3 out of 10 on the ESAS‑r breathlessness scale while at rest: you must rate your shortness of breath as 3 or higher on a 0‑10 questionnaire.

Who cannot join the trial?

8 criteria

If you have a sudden worsening of breathlessness that could be better treated with medication for your specific disease, you cannot join the study.
If you are unable to understand the study because of mental inability, unwillingness, or language difficulties, you cannot join the study.
If the doctor decides there is a contraindication (meaning the study drug is not safe for you), such as an allergy to morphine or if you are currently pregnant or planning to become pregnant, you cannot join the study.
If you are taking methadone (a strong pain medication) at any dose, you cannot join the study.
If you are using a high amount of other opioid pain medicines—more than the equivalent of 160 mg morphine per day (which is similar to more than 50 µg fentanyl, 80 mg oral oxycodone, 60 mg injected oxycodone, or 16 mg injected hydromorphone) in the last 24 hours, you cannot join the study.
If you have received the study’s randomized treatment within the past 6 hours, you cannot join the study.
If you have already received the study’s randomized treatment 8 times, you cannot join the study.
If you have participated in another clinical trial with an investigational medicine within the last 30 days, you cannot join the study.

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Verified sites

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Verified
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden
Verified
Region Skane Skanes Universitetssjukhus
Lund, Sweden

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Investigated drugs

Morphine is an opioid medication that helps reduce the feeling of breathlessness in people with severe illness. In this trial, it was given as a liquid that is injected under the skin. The drug works by calming the part of the brain that controls breathing discomfort, allowing patients to feel less shortness of breath during the study period.

What is already known about the treatment

Natriumklorid Fresenius Kabi 9 mg/ml infusionsvätska, lösning
This medication is given as a subcutaneous injection of a clear liquid solution. It is a well‑known electrolyte (sodium chloride) used to replace salt and water in the body and has no specific effect on breathlessness, so it serves as a placebo in this study. Sodium chloride works by providing sodium and chloride ions that help keep the body’s fluid balance normal. It is classified as an electrolyte solution.
Morfin Abcur, 10 mg/ml, injektionsvätska, lösning
This drug is administered by subcutaneous injection as a clear liquid solution. It is a widely used opioid pain medicine that is also prescribed to ease severe breathlessness in people with advanced illness. Morphine works by attaching to opioid receptors in the brain and spinal cord, which lowers the feeling of pain and the urge to breathe heavily. It belongs to the opioid analgesic class.

Investigated diseases

Respiratory tract disease - A respiratory tract disease is any condition that affects the airways, lungs, or surrounding structures, leading to symptoms such as breathlessness, cough, and wheeze. It may begin with mild irritation or inflammation and can progress to chronic changes that narrow the airways or impair gas exchange. Over time the difficulty in breathing often increases as the lungs become less able to move air efficiently. The condition can develop slowly, with symptoms gradually worsening, or it may flare up suddenly, causing a rapid increase in breathlessness.