Salbutamol for Analgesia in Renal Colic (SARC)

Phase 1

• Conditions: Renal colic; MedDRA version: 20.1 Level: PT Classification code 10038419 Term: Renal colic System Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2018-004305-11-GB
• Lead Sponsor: niversity Hospitals of Derby & Burton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-24
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 118

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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:
•ischaemic heart disease
•arrhythmogenic heart disease
•valvular heart disease
•unilateral kidney
13.Any other contraindication to the use of salbutamol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified