RecruitingPhase 2NCT06345716

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


Sponsor

University of Monastir

Enrollment

1,500 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • 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 Criteria3

  • Inability to appreciate pain according to the VAS.
  • Pregnant or breastfeeding woman.
  • Renal insufficiency with creatinine clearance \< 60 ml/min.

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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


Locations(1)

Semir Nouira

Monastir, Tunisia

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NCT06345716


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