Salbutamol for Analgesia in Renal Colic (SARC)

Salbutamol for analgesia in renal colic: A prospective, randomised, placebo controlled Phase II trial - Salbutamol for Analgesia in Renal Colic (SARC) v1.0

Status

Not yet recruiting

Phases

Phase 2Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004305-11-GB

Enrollment

118

Registered

2019-05-24

Start date

2019-07-08

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal colic MedDRA version: 20.1 Level: PT Classification code 10038419 Term: Renal colic System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: Ventolin Injection 500 micrograms in 1ml Product Name: Ventolin Injection 500 micrograms in 1ml Pharmaceutical Form: Injection INN or Propos

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore whether salbutamol improves the pain associated with renal colic, when added to the conventional pain relief for patients presenting to the emergency department with subsequently confirmed renal colic.; Secondary Objective: To explore whether salbutamol improves the pain associated with renal colic, when added to the conventional pain relief for patients presenting to the emergency department with suspected renal colic. To assess the feasibility of conducting a definitive phase III multi-centre randomised controlled trial (RCT) of the cost and clinical effectiveness of salbutamol as an analgesic adjunct for patients with renal colic when added to the standard analgesic regime in the ED. ;Primary end point(s): The primary outcome will be the difference in the change in pain scores (measured on an 100mm Visual Analogue Scale [VAS]) from baseline to 30 minutes post drug administration between trial arms in patients with "Confirmed Renal Colic". ;Timepoint(s) of evaluation of this end point: 30 minutes from time of IMP injection	—

Measure

Time frame

Main Objective: To explore whether salbutamol improves the pain associated with renal colic, when added to the conventional pain relief for patients presenting to the emergency department with subsequently confirmed renal colic.; Secondary Objective: To explore whether salbutamol improves the pain associated with renal colic, when added to the conventional pain relief for patients presenting to the emergency department with suspected renal colic. To assess the feasibility of conducting a definitive phase III multi-centre randomised controlled trial (RCT) of the cost and clinical effectiveness of salbutamol as an analgesic adjunct for patients with renal colic when added to the standard analgesic regime in the ED. ;Primary end point(s): The primary outcome will be the difference in the change in pain scores (measured on an 100mm Visual Analogue Scale [VAS]) from baseline to 30 minutes post drug administration between trial arms in patients with "Confirmed Renal Colic". ;Timepoint(s) of evaluation of this end point: 30 minutes from time of IMP injection

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Secondary

Measure	Time frame
Secondary end point(s): 1. The difference in the change in pain scores (measured on an 100mm Visual Analogue Scale [VAS]) from baseline to 30 minutes post drug administration between trial arms in patients with "Suspected Renal Colic" 2. The difference in the change from baseline pain score to pain scores at the following time points between trial arms: 15min, 60min, 120min, 240min, and then four-hourly thereafter, until 24 hours post drug administration or hospital discharge (whichever happens first) in both of the above subgroups. 3. The difference in the change in qualitative pain description from baseline pain assessment to pain assessments at the following time points between trial arms as measured using the short-form McGill Pain Questionnaire: 15min, 30min, 60min, 120min post drug administration. 4. Frequency and dose of morphine during the first 24 hours from enrolment (including prehospitally) 5. Any other analgesics required and the timing of their administration 6. Length of hospital stay ; Timepoint(s) of evaluation of this end point: 1. At 30 minutes post drug administration 2. 15 minutes, 60 minutes, 120 minutes. Then four hourly from 4 hours, 8 hours, 12 hours, 16 hours, 20 hours and 24 hours (or hospital discharge, whichever is first), all from the time of drug administration. 3. 15min, 30min, 60min, 120min post drug administration. 4. Logged for the 24 hour study period, or until hospital discharge, whichever is first. 5. Logged for the 24 hour study period, or until hospital discharge, whichever is first. 6. Logged for the 24 hour study period, or until hospital discharge, whichever is first.	—

Measure

Time frame

Secondary end point(s): 1. The difference in the change in pain scores (measured on an 100mm Visual Analogue Scale [VAS]) from baseline to 30 minutes post drug administration between trial arms in patients with "Suspected Renal Colic" 2. The difference in the change from baseline pain score to pain scores at the following time points between trial arms: 15min, 60min, 120min, 240min, and then four-hourly thereafter, until 24 hours post drug administration or hospital discharge (whichever happens first) in both of the above subgroups. 3. The difference in the change in qualitative pain description from baseline pain assessment to pain assessments at the following time points between trial arms as measured using the short-form McGill Pain Questionnaire: 15min, 30min, 60min, 120min post drug administration. 4. Frequency and dose of morphine during the first 24 hours from enrolment (including prehospitally) 5. Any other analgesics required and the timing of their administration 6. Length of hospital stay ; Timepoint(s) of evaluation of this end point: 1. At 30 minutes post drug administration 2. 15 minutes, 60 minutes, 120 minutes. Then four hourly from 4 hours, 8 hours, 12 hours, 16 hours, 20 hours and 24 hours (or hospital discharge, whichever is first), all from the time of drug administration. 3. 15min, 30min, 60min, 120min post drug administration. 4. Logged for the 24 hour study period, or until hospital discharge, whichever is first. 5. Logged for the 24 hour study period, or until hospital discharge, whichever is first. 6. Logged for the 24 hour study period, or until hospital discharge, whichever is first.

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Countries

United Kingdom

Contacts

Public ContactDr Graham Johnson

University Hospitals of Derby & Burton NHS Foundation Trust

graham.johnson4@nhs.net01332 787867

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 18, 2026