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Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic

Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06345716
Acronym
RC
Enrollment
1500
Registered
2024-04-03
Start date
2024-04-10
Completion date
2025-11-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Colic

Keywords

renal colic, paracetamol-tramadol, paracetamol-cafeine, placebo

Brief summary

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

DRUGparacétamol tramadol

Each patient received 1 tablet \* 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days

DRUGParacétamol cafeine

Each patient received 1 tab \* 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days

DRUGPlacebo

Each patient received 1 tab \* 3 / d of placebo (flour) every day for 7 days

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of RC and ED readmission7 day after inclusionincluded recurrence of RC and ED readmission within 7-day follow-up

Secondary

MeasureTime frameDescription
mean time interval7 day after inclusionmean time to recurrence of pain
side effects7 days 30 daysoccurence of side effects

Other

MeasureTime frameDescription
Adverse effects7 days 30 days-Adverse effects of treatment and its tolerance.

Countries

Tunisia

Contacts

Primary ContactKhaoula Bel Haj Ali
belhajalikhaoula@yahoo.fr99792724
Backup ContactSemir Nouira, Pr
21673106046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026