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

University of Monastir

Status and phase: Enrolling; Phase 2

Conditions: Renal Colic

Treatments: Drug: Paracétamol cafeine; Drug: Placebo; Drug: paracétamol tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT06345716

renal colic 2024

Details and patient eligibility

About

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.

Full 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)

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 3 patient groups

Paracétamol-tramadol

Experimental group

Description:

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

Treatment:

Drug: paracétamol tramadol

Paracetamol-caffeine

Experimental group

Description:

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

Treatment:

Drug: Paracétamol cafeine

Placebo

Experimental group

Description:

Each patient received 1 tab \* 3 / d of placebo (flour) every day for 7 days. \*For the three groups, the tablets were packaged hermetically in identical envelopes taken at random to respect double blinding.

Treatment:

Drug: Placebo