Salbutamol for Analgesia in Renal Colic (SARC) v1.0: a prospective, randomised, placebo-controlled Phase II trial
Renal colic
The study is a placebo-controlled randomised trial, therefore the participants will receive either salbutamol or placebo in addition to their standard pain relief and this allocation will be 1:1. A patient will present to the emergency department at the Royal Derby Hospital complaining of pain. They will be assessed on arrival and receive treatment for their pain, as per standard care. When it is felt by the assessing clinician that renal colic is the likely diagnosis, they will be assessed against screening criteria and approached about the trial. They will be provided with written information about the trial by a GCP trained member of staff. They will be given time to consider this and given the opportunity to ask questions and if they are happy to take part in the trial, asked to complete the consent form. Given the nature of the condition being studied, consent will need to be given within a short time-scale. Previous emergency department pain studies have achieved this. In addition, the Patient and Public Involvement group (which has representation from patients with previous renal colic) have felt that this is appropriate and achievable. The treating clinician will then prescribe trial medication on the department prescription chart. This will be taken to another part of the department with staff not involved in the care of the patient. They will draw a pre-made scratch card from a sealed box, which will reveal the treatment allocation for the participant. They will prepare either the active drug or placebo and take this to the treating team. Scratch cards have been used for randomisation processes in other studies, chiefly in the ambulance services. They are ideal for time-pressured environments and when access to computer randomisation may be limited. Patients with renal colic can present to the emergency department at any time, therefore we will be recruiting 24 hours a day. Having dedicated research staff available is not feasible for that, therefore
1. Subjects capable of giving informed consent 2. Age >=18 years 3. Working diagnosis of renal colic, as suggested by severe flank/unilateral abdominal pain, +/- radiating to suprapubic/groin area 4. Experiencing severe pain with a requirement for intravenous analgesia
Current participant exclusion criteria as of 19/02/2020: 1. Abdominal aortic aneurysm not yet excluded and participant aged > = 50 2. Ectopic pregnancy not yet excluded in a female of child-bearing potential 3. Currently actively taking part in another CTIMP 4. Previous participant in this trial 5. Unable to understand verbal and/or written information in English 6. Known allergy to salbutamol 7. Evidence of sepsis or clinical suspicion of urinary tract infection 8. Serum potassium < 3.7mmol/l 9. Concomitant use of: beta blockers (including eye drops); prolonged release opiates; long-acting β-agonists 10. Use of short-acting β2-agonists within the 6 hours preceding presentation to the emergency department 11. Current arrhythmia 12. History of any of: 12.1. Ischaemic heart disease 12.2. Arrhythmogenic heart disease 12.3. Valvular heart disease 12.4. Unilateral kidney 13. Any other contraindication to the use of salbutamol Previous participant exclusion criteria: 1. Abdominal aortic aneurysm not yet excluded and participant aged > = 50 2. Ectopic pregnancy not yet excluded in a female of child-bearing potential 3. Currently actively taking part in another CTIMP 4. Previous participant in this trial 5. Unable to understand verbal and/or written information in English 6. Known allergy to salbutamol 7. Evidence of sepsis or clinical suspicion of urinary tract infection 8. Serum potassium < 3.7mmol/l as measured on “point-of-care” venous blood gas 9. Concomitant use of: beta blockers (including eye drops); prolonged release opiates; long-acting β-agonists 10. Use of short-acting β2-agonists within the 6 hours preceding presentation to the emergency department 11. Current arrhythmia 12. History of any of: 12.1. Ischaemic heart disease 12.2. Arrhythmogenic heart disease 12.3. Valvular heart disease 12.4. Unilateral kidney 13. Any other contraindication to the use of salbutamol