Comparing pain relief from paracetamol-tramadol and paracetamol-caffeine for renal colic
Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic
This study tests whether a combination of paracetamol-tramadol or paracetamol-caffeine can provide better pain relief for people who have just been treated for kidney stones.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Monastir Academic / other |
| Locations | 1 site (Monastir) |
| Trial ID | NCT06345716 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two pain relief combinations, paracetamol-tramadol and paracetamol-caffeine, compared to a placebo in patients discharged from the Emergency Department after treatment for renal colic. It is a prospective, randomized, single-blind study where eligible patients are assigned to one of the three groups upon discharge. Various parameters, including pain intensity and vital signs, are collected to assess the outcomes of the treatments. The study aims to determine which combination provides better pain management for patients experiencing renal colic.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced sudden flank or lumbar pain consistent with renal colic and have a pain score below 30 at discharge.
Not a fit: Patients who are pregnant, breastfeeding, or have renal insufficiency with low creatinine clearance will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide more effective pain management options for patients suffering from renal colic.
How similar studies have performed: Other studies have explored similar pain management approaches, but the specific combinations being tested in this trial are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * -Age \> 18 years old. * Consent to participate in the study. * Pain in the flank/lumbar fossa of sudden onset with urine strips and/or imaging corresponding to the diagnosis of renal colic. * Pain score at discharge \< 30 (visual analog scale - VAS or verbal numerical scale - VAS from 0 to 100). Exclusion Criteria: * -Inability to appreciate pain according to the VAS. * Pregnant or breastfeeding woman. * Renal insufficiency with creatinine clearance \< 60 ml/min.
Where this trial is running
Monastir
- Semir Nouira — Monastir, Tunisia (Recruiting)
Study contacts
- Study coordinator: Khaoula Bel Haj Ali
- Email: belhajalikhaoula@yahoo.fr
- Phone: 99792724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.