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

Phase 2

Completed

• Conditions: Renal colic; Urological and Genital Diseases; Unspecified renal colic

• Registration Number: ISRCTN14552440
• Lead Sponsor: Derby Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-22
• Study Completion: 2022-09-22
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1. Subjects capable of giving informed consent
2. Age > = 18
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

Exclusion Criteria

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 ß-agonists
10. Use of short-acting ß2-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 ß-agonists
10. Use of short-acting ß2-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pain score measured using a 100 mm Visual Analogue Scale (VAS) at baseline and 30 minutes post drug administration in patients with confirmed renal colic