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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | In this group patient will receive 1000mg intravenous injection of paracetamol in combination with 4ml intravenous normal saline as placebo, and 5ml nebulisation of normal saline during 10min. |
|
| Dexamethasone group | Active Comparator | In this group, patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml intravenous dexamethasone (8mg), and 5ml nebulisation of of normal saline during 10min as placebo. |
|
| Terbutaline group | Active Comparator | In this 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 120 minutes post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | The occurrence of adverse effects | 120 minutes post-intervention |
| Rescue analgesia. | The number of patients who need rescue analgesia. |
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Inclusion criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Semir Nouira, Professor | Contact | 216_731-06046 | semir.nouira.urg@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Fattouma Bourguiba Monastir | Monastir | 5000 | Tunisia |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013726 | Terbutaline |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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. |
|
| 120 minutes post-intervention |
| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |