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AbgeschlossenPhase IIInterventionell

Does salbutamol reduce the pain of kidney stones when used alongside normal pain relief?

Passing a kidney stone can be intensely painful. When a stone gets stuck in the ureter (the narrow tube linking your kidney to your bladder), it causes muscle spasms and sharp cramps known as renal colic. Standard painkillers do not always clear the pain completely and can cause unpleasant side effects like sickness and drowsiness. Researchers believe that salbutamol, a medicine commonly used in asthma inhalers to open airways, may also relax the muscular tube where the stone is trapped. By relaxing these muscles, it might reduce cramping and calm severe pain. This UK hospital trial is comparing salbutamol given through a drip against a dummy salt-water injection (placebo). All patients will still receive their normal, strong pain relief. Researchers want to find out if adding salbutamol makes a meaningful difference to pain control and comfort during an emergency hospital visit.

Auf einen Blick

Status
Abgeschlossen
Phase
Phase II
Sponsor
Derby Hospitals NHS Foundation Trust
Einschreibeziel
152
Starten
16 Sep 2019
Geschätzte Fertigstellung
22 Sep 2022

Worum geht es in dieser Studie?

Kidney stones are small, hard crystals that form inside the kidneys. When a stone moves out of the kidney and gets stuck in the ureter (the tube that carries urine to the bladder), it triggers intense, cramping pain in the back and lower tummy. This sudden condition is known as renal colic and is a frequent reason people visit the Emergency Department (A&E).

Doctors normally treat this severe pain with strong painkillers given through an injection or drip. However, these medicines do not always work completely. They can also cause unwanted side effects such as nausea, dizziness, and extreme drowsiness. Finding new ways to safely tackle this pain is an important goal for emergency medical teams.

Early laboratory research shows that salbutamol—a trusted and affordable medicine widely used to treat asthma—can relax the smooth muscle walls of the human ureter. By helping the tube relax, salbutamol may stop the painful spasms and allow the stone to pass more comfortably. This trial is the first in humans to test whether salbutamol actually reduces kidney stone pain when used alongside standard pain medicines.

Around 100 emergency patients are taking part in this study. The results will help doctors decide if salbutamol shows promise and whether a larger, nationwide clinical trial should take place. If successful, this simple treatment could give hospital teams a new, effective tool to help relieve kidney stone pain faster.

Wichtige Erkenntnisse

  • Testing whether asthma drug salbutamol helps reduce severe pain from kidney stones.
  • Participants receive the trial drug or a placebo alongside all standard pain relief.
  • Open to adults aged 18 and over attending hospital with suspected renal colic.
  • Pain levels and vital signs are tracked for 24 hours while in hospital.
  • No extra hospital visits or long-term check-ups are required after discharge.

Wer könnte berechtigt sein?

This trial is open to adults aged 18 and older who arrive at hospital with severe, sudden pain that doctors strongly suspect is caused by a kidney stone. To be eligible, your pain must be severe enough to require strong painkillers given directly into a vein, and you must be able to understand the study details and give your consent.

The trial is not suitable for people with certain medical conditions. You cannot take part if you have a history of heart disease, heart rhythm problems, or only one kidney. It is also unsuitable for anyone with an allergy to salbutamol, very low potassium levels in their blood, or anyone taking medicines such as beta-blockers or specific asthma treatments that could clash with the study drug.

Before you can join, doctors will also run checks to confirm that your symptoms are not caused by other urgent conditions, such as a problem with a major blood vessel (an abdominal aneurysm) or a pregnancy outside the womb (ectopic pregnancy).

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. I am aged 18 or over.
  2. I have severe back or lower tummy pain suspected to be a kidney stone.
  3. I do not have a history of heart disease or irregular heart rhythms.
  4. I have not taken asthma inhalers or beta-blocker medicines in the last few hours.
  5. I am not allergic to salbutamol.
  6. I have two functioning kidneys.
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

Taking part happens entirely during your emergency hospital visit. If you agree to participate, you will be placed into one of two groups by chance (randomly). One group receives salbutamol through a drip into a vein, and the other group receives a simple salt-water injection (a placebo). Neither you nor your care team will know which one you receive. You will still receive all of your usual, strong painkillers as normal. Hospital staff will check your pain levels, heart rate, and blood pressure regularly over the next 24 hours. Taking part will not keep you in hospital any longer than necessary, and there are no extra appointments or clinic visits to attend once you are discharged home.

Potenzielle Risiken und Vorteile

There is no guarantee that taking part will improve your pain, as doctors do not yet know if salbutamol works for kidney stones. However, taking part will provide vital information that could improve pain treatment for future patients. Salbutamol is a widely used and well-tested medicine, but it can occasionally cause short-lived side effects, such as a mild tremor (shaky hands), muscle cramps, a headache, or a fast heartbeat. Joining the study is entirely your choice. You are free to stop at any time, and doing so will never affect your medical care or your access to standard pain relief.

Standorte (1)

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  • Universitätskliniken von Derby und Burton NHS Stiftungstreuhand
    Nur Stadt
    Derby, England

Häufige Fragen

Will I still receive standard pain relief if I join?

Yes. Your comfort and care come first. You will receive all the usual, strong pain relief given to anyone arriving at hospital with kidney stones.

Was ist ein Placebo?

A placebo is a dummy treatment that looks identical to the real medicine but contains no active ingredients—in this trial, it is a plain, sterile salt-water solution.

Why is an asthma drug being tested for kidney stones?

Salbutamol relaxes the tight muscles in the airways of people with asthma. Laboratory tests show it can also relax the muscle tube connecting the kidney to the bladder, which might relieve painful spasms.

Will taking part make my hospital stay longer?

No. Taking part will not delay your discharge or extend your stay. All monitoring takes place while you are receiving your standard emergency care.

Do I need to return to the hospital for follow-up visits?

No. The study only monitors your symptoms and vital signs for 24 hours while you are in hospital. There are no clinic check-ups after you go home.

Wie Sie mehr erfahren können

Graham Johnson

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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