Salbutamol for Analgesia in Renal Colic (SARC) v1.0
Research type
Research Study
Full title
Salbutamol for analgesia in renal colic: A prospective, randomised, placebo controlled Phase II trial
IRAS ID
252075
Contact name
Graham Johnson
Contact email
Sponsor organisation
University Hospitals of Derby & Burton NHS Foundation Trust
Eudract number
2018-004305-11
Duration of Study in the UK
1 years, 10 months, 16 days
Research summary
Research Summary
Kidney stones can become stuck in the ureter (the tube between the kidney and the bladder) in a condition known as renal colic. Patients with renal colic often attend the Emergency Department due to high levels of pain; traditional painkillers are only partly effective in reducing this pain, and can have side effects such as sleepiness and being sick.
There is evidence that salbutamol (a drug used to treat asthma) relaxes the human ureter and we believe this may reduce the pain associated with kidney stones, however there have been no studies in humans to demonstrate this effect.
In this trial, patients with suspected kidney stones who consent to take part will be randomly chosen to receive an intravenous injection of either salbutamol (the active drug) or placebo (saline). The study will be double-blind, so neither the patient nor the research team will know which drug was given.
We will collect information about patients’ pain levels over the following 24 hours, along with information on their vital signs, e.g their heart rate to monitor the drug's effectiveness. Patients will still be given all normal pain relief, both on their arrival and during their time in hospital.
This is the first trial investigating this treatment for renal colic so we are conducting a small study of approximately 100 patients with the condition. The main aim is to see if salbutamol has any possible effect on the pain caused by kidney stones and the results of this study will help with the design of a further, much larger research project to further explore this.
Summary of Results
Background and study aims Kidney stones can become stuck in the ureter (the tube between the kidney and the bladder) in a condition known as renal colic. Patients with renal colic often attend the Emergency Department due to severe pain. Traditional painkillers are only partly effective in reducing this pain and have side effects. There is evidence that salbutamol (a drug used to treat asthma) relaxes the human ureter and this may reduce the pain. This is the first trial investigating this treatment for renal colic so the researchers have conducted a small study of 106 patients with the condition. The main aim is to see if salbutamol has any effect on the pain caused by kidney stones.
Methods
Participants were randomly allocated to receive an intravenous injection of either salbutamol (the active drug) or placebo (saline). Neither the patient nor the research team knew which drug was given. Information was collected about patients’ pain levels over the following 24 hours, along with information on their vital signs, such as their heart rate to monitor the drug's effectiveness. Patients were still given all normal pain relief, both on their arrival and during their time in hospital.Key findings
Salbutamol does not improve the pain of renal colic when given alongside normal pain killers to emergency department patients. Patients who received salbutamol had no difference in the amount of other pain relief required or the length of their hospital stay.Dissemination
Study findings will be published in a peer-reviewed journal, presented at conferences and shared with relevant patient groups.Patient and public involvement
Patients and members of the public were involved in the design of this study, and were part of the study management committee.Conclusions and future plans
No further research is planned as a result of this study.REC name
West of Scotland REC 1
REC reference
19/WS/0087
Date of REC Opinion
10 Jun 2019
REC opinion
Favourable Opinion