Renal Colic
Conditions
Keywords
Renal Colic, Dexamethasone
Brief summary
Adult patients (18-55 years of age) with clinical diagnosis of acute renal colic (sudden sharp colic flank pain with or without radiation to genitalia or groin and with or without urinary symptoms) who had pain score of 5 or more measured by 10-cm visual analogue scale (VAS), will be included. Will be excluded those who had history of cardiovascular, hepatic, renal or metabolic diseases, patients with evidence of sepsis or clinical suspicion of urinary tract infection, hemodynamically unstable patients (systolic blood pressure <90 mmHg), patients with uncontrolled diabetes, pregnancy, breastfeeding, patients unable to understand verbal and/or written information, patients receiving analgesics within 6 hours before presentation, serum potassium less than 3.7 mmol/l, concomitant use of any beta blockers (including beta-blocker containing eye drops), prolonged-release long-acting β-agonists, use of short-acting β2-agonists within the 6 h preceding presentation to the emergency department, any contraindication to the use of terbutaline, history of drug dependence or chronic consumption of alcohol. Will be also excluded patients with known allergy to paracetamol or terbutaline, patients with abdominal tenderness as a sign of peritoneal inflammation and those with any clinical suspicion for diseases other than urolithiasis, including abdominal aortic aneurysm or dissection.
Interventions
DRUGTerbutaline 2.5 mg
In this study group, patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml IV normal saline as placebo, and 5mg terbutaline in 5ml nebulisation during 10min.
DRUGDexamethasone
Patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml of 2ml intravenous dexamethasone (8mg) and 2 ml of saline sérum, and 5ml nebulisation of of normal saline during 10min as placebo.
DRUGPlacebo
Patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml of intravenous saline serum (placebo) with 5ml nebulized of normal saline (placebo) during 10min as placebo.
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 years * Clinical diagnosis of acute renal colic (defined as sudden sharp colicky flank pain with or without radiation to the genitalia or groin, and with or without urinary symptoms) * Pain score of 5 or more measured using the 10-cm NRS scale
Exclusion criteria
* History of cardiovascular, hepatic, renal, or metabolic diseases * Evidence of sepsis or clinical suspicion of urinary tract infection * Hemodynamically unstable (systolic blood pressure \< 90 mmHg) * Uncontrolled diabetes * Pregnancy or breastfeeding * Inability to understand verbal and/or written information * Received any analgesics within 6 hours prior to presentation * Serum potassium \< 3.7 mmol/L * Concomitant use of: Any beta-blockers (including beta-blocker-containing eye drops) Prolonged-release long-acting β-agonists Short-acting β2-agonists within 6 hours prior to presentation * Contraindication to terbutaline use * Known allergy to paracetamol or terbutaline * Abdominal tenderness suggestive of peritoneal inflammation * Clinical suspicion of conditions other than urolithiasis, including: * Abdominal aortic aneurysm * Aortic dissection * History of drug dependence or chronic alcohol consumption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change level of NRS by 50%. | 120 minutes post-intervention | The efficacy of the drug with regards to reducing the Numerical Rating Scale (NRS) A scale from 0 to 10 with 0 meaning "no pain" and 10 meaning "worst imaginable pain."during the follow-up. Criteria for treatment response was determined as pain reduction level by 50% based on the primary NRS score or NRS score of four or lower. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 120 minutes post-intervention | The occurrence of adverse effects |
| Rescue analgesia. | 120 minutes post-intervention | The number of patients who need rescue analgesia. |
Countries
Tunisia
Contacts
CONTACTSemir Nouira, Professor
Outcome results
None listed