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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Renal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Paracétamol-tramadol

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

Group Type EXPERIMENTAL

paracétamol tramadol

Intervention Type DRUG

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

Paracetamol-caffeine

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

Group Type EXPERIMENTAL

Paracétamol cafeine

Intervention Type DRUG

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

Placebo

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

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

Interventions

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paracétamol tramadol

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

Intervention Type DRUG

Paracétamol cafeine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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B A C

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No