Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED

ConditionRenal Colic
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Monastir

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Terbutaline 2.5 mg

    Drug

    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.

  • Dexamethasone

    Drug

    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.

  • Placebo

    Drug

    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.

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Placebo groupPlacebo comparator 1 intervention
Group B: Dexamethasone groupActive comparator 1 intervention
Group C: Terbutaline groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change level of NRS by 50%.

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.

Time frame
120 minutes post-intervention

Secondary outcomes

1

Adverse effects

The occurrence of adverse effects

Time frame
120 minutes post-intervention
2

Rescue analgesia.

The number of patients who need rescue analgesia.

Time frame
120 minutes post-intervention

Other outcomes

Sponsors and contacts

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