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NCT Number: NCT06345716

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

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paracétamol tramadol

Drug

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

Other names: B

Paracétamol cafeine

Drug

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

Other names: A

Placebo

Drug

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

Other names: C

Primary outcomes

  1. Recurrence of RC and ED readmission

    Time frame: 7 day after inclusion

    included recurrence of RC and ED readmission within 7-day follow-up

Secondary outcomes

  1. mean time interval

    Time frame: 7 day after inclusion

    mean time to recurrence of pain

  2. side effects

    Time frame: 7 days 30 days

    occurence of side effects

Other outcomes

  1. Adverse effects

    Time frame: 7 days 30 days

    -Adverse effects of treatment and its tolerance.

Study contacts

Contact information is provided by the study sponsor or research team.

Khaoula Bel Haj Ali

CONTACT

[email protected]

99792724

Semir Nouira, Pr

CONTACT

21673106046

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Acronym: RC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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