Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Terbutaline 2.5 mg, Dexamethasone, Placebo.
- Who it may be relevant to
- Registry conditions: Renal Colic. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tunisia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Increment Value of Intravenous Dexametasone Versus Nebulized Terbutaline for Renal Colic Pain Management in the Emergency Department: A Randomized Clinical Trial
Overview
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
- Drug Terbutaline 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. - Drug Dexamethasone
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. - Drug Placebo
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.
Primary outcome measures
- Change level of NRS by 50%. [Time frame: 120 minutes post-intervention]
Secondary outcome measures (2)
- Adverse effects [Time frame: 120 minutes post-intervention]
- Rescue analgesia. [Time frame: 120 minutes post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Tunisia · 1 center
- University Hospital Fattouma Bourguiba Monastir — Monastir
Identifiers
NCT: NCT06980727 · Renal Colic Terbutaline