Renal ColicPhase 3NCT06980727
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
A Phase 3 study testing Terbutaline 2.5 mg and Dexamethasone in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- Terbutaline 2.5 mg and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- 8 Aug 2026to 1 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
University Hospital Fattouma Bourguiba Monastir
Monastir, Monastir Governorate, 5000
About this study
Official title: Increment Value of Intravenous Dexametasone Versus Nebulized Terbutaline for Renal Colic Pain Management in the Emergency Department: A Randomized Clinical 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 \&lt;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.
- Conditions
- Renal Colic
- Being tested
- Terbutaline 2.5 mg, Dexamethasone, Placebo
- Keywords
- Renal Colic, Dexamethasone
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbutaline 2.5 mgDrug
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.
DexamethasoneDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo |
| 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. Receives: Drug: Dexamethasone |
| 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 Receives: Drug: Terbutaline 2.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes post-intervention
Secondary outcomes (2)
Adverse effects
The occurrence of adverse effects
Measured: 120 minutes post-intervention
Rescue analgesia.
The number of patients who need rescue analgesia.
Measured: 120 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start8 Aug 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980727
- Sponsor's protocol ID
- Renal Colic Terbutaline
- Status last verified
- Nov 2026
- First submitted
- 7 May 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increment Value of Intravenous Dexametasone Versus Nebulized Terbutaline for Renal Colic Pain Management in the Emergency Department: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06980727
- Acronym / sponsor ID
- Renal Colic Terbutaline
- Conditions
- Renal Colic
- Keywords
- Renal Colic, Dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 8 Aug 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 \&lt;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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: PlaceboIn 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 | Drug: DexamethasoneIn 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 | Drug: Terbutaline 2.5 mgIn 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terbutaline 2.5 mgIn 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 | Terbutaline group |
| DexamethasonePatients 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 | Dexamethasone group |
| PlaceboPatients 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. | Drug | Placebo group |
Primary outcome
Change level of NRS by 50%.
Time frame: 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.
2 secondary outcomes
Adverse effects
Time frame: 120 minutes post-intervention
Rescue analgesia.
Time frame: 120 minutes post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Terbutaline 2.5 mg and Dexamethasone in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Semir Nouira, Professor (216_731-06046, semir.nouira.urg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change level of NRS by 50%. (time frame: 120 minutes post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.