Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic
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: paracétamol tramadol, Paracétamol cafeine, Placebo.
- Who it may be relevant to
- Registry conditions: Renal Colic. Basic parameters: 18 years — 99 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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Overview
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
Detailed description
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
Different parameters are collected on a standard form prepared for all cases of renal colic included in our study. This sheet essentially contains:
Temperature, systolic and diastolic blood pressure, heart rate, pain intensity assessed by VAS, abdominal tenderness as well as the existence of Giardano signs.
Additional examinations were not systematically carried out for all patients: AUSP, ECBU, renal ultrasound, creatinemia and blood sugar. Their realization depended on the clinical context.
The use of imaging was done following the indications specified in the text of the consensus of the French Society of Emergency Medicine (updated in 2008)
Interventions
- Drug paracétamol tramadol
Each patient received 1 tablet \* 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days - Drug Paracétamol cafeine
Each patient received 1 tab \* 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days - Drug Placebo
Each patient received 1 tab \* 3 / d of placebo (flour) every day for 7 days
Primary outcome measures
- Recurrence of RC and ED readmission [Time frame: 7 day after inclusion]
Secondary outcome measures (2)
- mean time interval [Time frame: 7 day after inclusion]
- side effects [Time frame: 7 days 30 days]
Eligibility 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.
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
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Tunisia · 1 center
- Semir Nouira — Monastir
Identifiers
NCT: NCT06345716 · renal colic 2024